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AbstractObjectiveMethodsResultsConclusions\nKEY POINTSTherapeutic drug monitoring (TDM) is an important tool for treatment optimisation. Its usefulness has recently been demonstrated for some first-line antidepressants; however, few studies have been reported on the relationship between blood levels of mirtazapine and its antidepressant effects. The aim of this study was to investigate the association between blood concentration of mirtazapine and antidepressant response.59 outpatients treated with mirtazapine for depression were recruited and followed up for three months in a naturalistic setting. Hamilton Depression Rating Scale-21 (HAMD-21) was administered at baseline, month 1, and month 3 to assess antidepressant response. Mirtazapine serum concentration was measured at steady state. Linear regression analysis and nonlinear least-squares regression were used to estimate association between serum concentration of mirtazapine and antidepressant response.Our results showed no overall association between serum concentration of mirtazapine and symptom improvement at month 1 and month 3. A marginally significantly higher serum concentration of mirtazapine was found in responders vs non-responders at month 3.The study suggests that serum concentration of mirtazapine is not strongly associated with the antidepressant efficacy of mirtazapine. This is probably attributed to its pharmacodynamic profile, even though higher blood levels seem to be marginally more effective.Mirtazapine plasma levels association with response is mild and do not follow the same curve of other antidepressantsMirtazapine higher plasma levels may show some benefit in a subgroup of patientsTherapeutic drug monitoring may help during antidepressant treatment [ABSTRACT FROM AUTHOR]

Analysis of melatonin in biological samples is a challenge for the analyst both because of its low concentration and because of the numerous interfering substances. Therefore, chromatography, as a powerful analytical technique used for the separation, detection, and quantification of analytes, can be the method of choice for determining melatonin in biological samples for clinical use and pharmacokinetic research. The method was developed and validated according to the internal documents in accordance with Good Laboratory Practice. The concentrations of melatonin in human serum were determined using a high-performance liquid chromatography method with a fluorescence detector and mirtazapine as an internal standard. Preparation of serum samples was performed by liquid–liquid extraction with ethyl acetate: n-hexane (1:1 v/v). High linearity was exhibited over a concentration range of 25–10,000 pg/mL of melatonin, with a correlation coefficient higher than 0.999 during the course of method validation. Repeatability and intermediate precision show a relative standard deviation lower than 6.6 %, and accuracies were from 90.7 % to 110.3 %. The lower limit of quantitation was 30 pg/mL, and the limit of detection was 7.92 pg/mL. The in-house method is simple, fast, reproducible, and applicable for the determination of melatonin in human serum. [ABSTRACT FROM AUTHOR]

This study evaluated the effect of sertraline with desvenlafaxine and sertraline with mirtazapine on HAM-D score and inflammatory markers (IL-6 and TNF-α levels) in major depressive disorder. Patients (18–60 years) with MDD diagnosed by DSM-V criteria and HAM-D score 18 or more were included (n = 60). Group A patients (n = 30) received sertraline 50 mg/day and desvenlafaxine 50 mg/day. Group B patients (n = 30) received sertraline 50 mg/day and mirtazapine 30 mg/day. All patients were followed up for 8 weeks for the evaluation of clinical efficacy, safety, serum IL-6, and TNF-α levels. Our study showed a comparatively similar and statistically significant (p < 0.05) reduction in HAM-D score in both groups in the 4th and 8th week of the treatment. Both drug combinations significantly (p < 0.05) decreased serum IL-6 and TNF-α after 8 weeks of treatment. The present study suggests that the combination therapy (as treatment initiation) with sertraline and desvenlafaxine, and sertraline with mirtazapine is effective and well tolerated in MDD patients with moderate to severe depression, and their therapeutic efficacy is accompanied by decreased inflammatory markers (serum IL-6 and TNF-α). Recent evidence indicates that combination therapy of antidepressant drugs started as treatment initiation produces superior treatment outcomes in patients of MDD with moderate to severe depression. MDD is associated with increased inflammatory markers. Combination therapy of sertraline with desvenlafaxine and sertraline with mirtazapine as treatment initiation is effective and well tolerated in MDD patients. The therapeutic efficacy of sertraline with desvenlafaxine and sertraline with mirtazapine is associated with a significant decrease in serum levels of IL-6 and TNF-α. [ABSTRACT FROM AUTHOR]

This study aimed to explore male-female differences in suicide ideation (SI) and suicide risk factors in major depressive disorder (MDD). We analysed 482 adults (sample 1) and 438 elderly outpatients (sample 2) with MDD. Sample 1 was treated with different antidepressant combinations (escitalopram; bupropion plus escitalopram; venlafaxine plus mirtazapine) and assessed by means of the Concise Health Risk Tracking (SI), Quick Inventory of Depressive Symptomatology, Altman Mania Rating Scale and Psychiatric Diagnostic Screening Questionnaire. Sample 2 was treated with venlafaxine and assessed using the Hamilton scale for depression, Anxiety Sensitivity Index and Penn State Worry Questionnaire for anxiety, Beck Scale for Suicide Ideation and Repeatable Battery for the Assessment of Neuropsychological Status. In sample 1, females had greater depression severity (O.R 0.961 99%CI: 0.929 − 0.995), males reported more alcohol abuse (O.R 1.299 99%CI: 1.118 − 1.509) and active SI (O.R 1.109 99%CI: 1.005 − 1.255). In sample 2 men showed more severe SI (O.R 1.067; 99%CI: 1.014 − 1.122) and weight loss (OR = 5.89 99%CI: 1.01 − 34.19), women more gastrointestinal symptoms. In these selected samples, although women had more severe depression, men had more suicide risk factors. Such differences might contribute to men's increased suicide risk. In major depressive disorder sex differences affect the clinical expression of depressive episodes. In comparison to men, women endorse higher levels of overall depression in adult MDD and more somatic anxiety and gastrointestinal symptoms in late-life MDD. After controlling for confounding variables, males have more severe SI and a larger number of suicide risk factors (eg. alcohol abuse; weight loss). The association between male sex and SI is detectable in both adults and elderly patients with MDD. Further studies are necessary to elucidate how sex differences in suicide ideation and suicide risk factors are related to men's increased suicide risk. [ABSTRACT FROM AUTHOR]

The development of Mirtazapine (MRT)-loaded aquasomes by co-precipitation sonication technique to boost the antidepressant potential of MRT. MRT-loaded aquasomes formulations were prepared using Box–Behnken design to investigate the effect of independent factors including sonication time (X1), sonication temperature (X2), and sugar concentration (X3) on the dependent variables as particle size and drug loading efficiency. The formulation of the optimized formula was verified by Fourier Transform Infrared Spectroscopy (FTIR), Differential Scanning Calorimetry (DSC), and X-ray Powder Diffraction (XRPD). Furthermore, the morphology of the formula was evaluated by Transmission Electron Microscopy (TEM). The optimum MRT- loaded aquasomes was assessed for physiochemical properties, in vitro MRT release and in vivo antidepressant effects in mice model. The results revealed that the optimized formula showed a small particle size of 202.7 ± 3.7 nm and a high loading efficiency of 77.65 ± 2.6%. Thermal DSC and XRPD studies demonstrated the amorphous nature of MRT-loaded aquasomes. The in vitro study demonstrated sustained release of F (opt) 88.16% after 8 h, compared with plain MRT release of 63.06% after 1 h. Mice treated with MRT-loaded aquasomes demonstrated reduced immobility time in behavioral analysis to 37% with MRT-loaded aquasomes, while plain MRT reduced it to 55%. These results confirmed that the antidepressant effect of MRT was significantly boosted in formulated aquasomes, and thereby they provide a promising carrier nano vesicular system for effective delivery of MRT. [ABSTRACT FROM AUTHOR]

Many drugs that serve as first-line medications for the treatment of depression are associated with severe side effects, including liver injury. Of the 34 antidepressants discussed in this review, four have been withdrawn from the market due to severe hepatotoxicity, and others carry boxed warnings for idiosyncratic liver toxicity. The clinical and economic implications of antidepressant-induced liver injury are substantial, but the underlying mechanisms remain elusive. Drug-induced liver injury may involve the host immune system, the parent drug, or its metabolites, and reactive drug metabolites are one of the most commonly referenced risk factors. Although the precise mechanism by which toxicity is induced may be difficult to determine, identifying reactive metabolites that cause toxicity can offer valuable insights for decreasing the bioactivation potential of candidates during the drug discovery process. A comprehensive understanding of drug metabolic pathways can mitigate adverse drug-drug interactions that may be caused by elevated formation of reactive metabolites. This review provides a comprehensive overview of the current state of knowledge on antidepressant bioactivation, the metabolizing enzymes responsible for the formation of reactive metabolites, and their potential implication in hepatotoxicity. This information can be a valuable resource for medicinal chemists, toxicologists, and clinicians engaged in the fields of antidepressant development, toxicity, and depression treatment. [ABSTRACT FROM AUTHOR]

Orally disintegrating tablets (ODTs) are designed to dissolve in the oral cavity within 3 min, providing a convenient option for patients as they can be taken without water. Direct compression is the most common method used for ODTs formulations. However, the availability of single composite excipients with desirable characteristics such as good compressibility, fast disintegration, and a good mouthfeel suitable for direct compression is limited. This research was proposed to develop a co-processed excipient composed of xylitol, mannitol, and microcrystalline cellulose for the formulation of ODTs. A total of 11 formulations of co-processed excipients with different ratios of ingredients were prepared, which were then compressed into ODTs, and their characteristics were thoroughly examined. The primary focus was on evaluating the disintegration time and hardness of the tablets, as these factors are important in ensuring the ODTs meet the desired criteria. The model drug, Mirtazapine was then incorporated into the chosen optimized formulation. The results showed that the formulation comprised of 10% xylitol, 10% mannitol and 80% microcrystalline cellulose demonstrated the fastest disintegration time (1.77 ± 0.119 min) and sufficient hardness (3.521 ± 0.143 kg) compared to the other formulations. Furthermore, the drug was uniformly distributed within the tablets and fully released within 15 min. Therefore, the developed co-processed excipients show great potential in enhancing the functionalities of ODTs, offering a promising solution to improve the overall performance and usability of ODTs in various therapeutic applications. [ABSTRACT FROM AUTHOR]

Cadmium (Cd) is one of the most hazardous metals to the environment and human health. Neurotoxicity is of the most serious hazards caused by Cd. Mirtazapine (MZP) is a central presynaptic α2 receptor antagonist used effectively in treating several neurological disorders. This study investigated the anti-inflammatory and antioxidant activity of MZP against Cd-induced neurotoxicity. In this study, rats were randomly divided into five groups: control, MZP (30 mg/kg), Cd (6.5 mg/kg/day; i.p), Cd + MZP (15 mg/kg), and Cd + MZP (30 mg/kg). Histopathological examination, oxidative stress biomarkers, inflammatory cytokines, and the impact of Nrf2 and NF-κB/TLR4 signals were assessed in our study. Compared to Cd control rats, MZP attenuated histological abrasions in the cerebral cortex and CA1 and CA3 regions of the hippocampus as well as the dentate gyrus. MZP attenuated oxidative injury by upregulating Nrf2. In addition, MZP suppressed the inflammatory response by decreasing TNF-α, IL-1β, and IL-6 mediated by downregulating TLR4 and NF-κB. It is noteworthy that MZP's neuroprotective actions were dose-dependent. Collectively, MZP is a promising therapeutic strategy for attenuating Cd-induced neurotoxicity by regulating Nrf2, and NF-κB/TLR4 signals, pending further study in clinical settings. [ABSTRACT FROM AUTHOR]

Chronic pruritus is frequently seen in daily dermatological practice and is associated with marked impact on quality of life. Research on the use of gabapentin and oral antidepressants in daily dermatological practice is scarce. To evaluate the efficacy and safety of gabapentin and oral antidepressants in patients with chronic pruritus in daily clinical practice. A prospective observational single-center cohort study was conducted including adult patients with chronic pruritus and an indication for systemic treatment between June 2016 and May 2019. Systemic treatment with gabapentin and/or antidepressants was initiated in 31 patients with severe chronic pruritus (median average pruritus NRS score 7.0), in which most cases no underlying origin was identified (83.9%). In patients treated with gabapentin 900–1800 mg/day (N = 25), median average pruritus NRS decreased to 5.5 (IQR 3.0) after 4 weeks and remained stable up to 24 weeks of treatment. Efficacy of antidepressants was variable, with the highest response after initiation of amitriptyline, nortriptyline, and mirtazapine. Side effects were frequently observed in both gabapentin and antidepressant treatments; however, were mostly mild and temporary. This was a single-site observational study, with limited sample size. Treatment with gabapentin and antidepressants should be considered in patients with chronic pruritus unresponsive to conventional treatment. [ABSTRACT FROM AUTHOR]

The response to antidepressants varies significantly among individuals and is difficult to predict before treatment. In this randomised control trial, we explored cytokines that correlate with the therapeutic effect of mirtazapine (MIR) and selective serotonin reuptake inhibitors (SSRIs) and whether they could be predictors of remission for each antidepressant. Plasma cytokines, such as tumour necrosis factor-α (TNF-α), interleukin (IL)-1β, IL-2, IL-4, IL-6, IL-8, and granulocyte-macrophage colony-stimulating factor (GM-CSF) were assayed in 95 participants before medication and assayed by the enzyme-linked immunosorbent assay. The Hamilton Rating Scale for Depression assessed depressive symptoms over 4 weeks. In the SSRI group, the baseline GM-CSF level was significantly higher in the remission group than in the non-remission group (p =.022). In the MIR group, the baseline level of TNF-α was significantly higher (p =.039) and IL-2 was lower (p =.032) in the remission group than in the non-remission group. In patients prescribed with MIR, the cut-off values of TNF-α (10.035 pg/mL) and IL-2 (1.170 pg/mL) calculated from the receiver operating characteristic curve suggested that the remission rate, which corresponds to a positive predictive value, could be increased from 31.3% to 60.0% and 50.0%, respectively. For those prescribed with SSRIs, the remission rate was 37.0% and using the cut-off value of GM-CSF (0.205 pg/mL), the remission rate could be almost doubled to 70%. Our study shows that pre-treatment plasma concentrations of TNF-α, IL-2, and GM-CSF may suggest the predictability of remission by SSRIs or MIR. [ABSTRACT FROM AUTHOR]

Employment of mesoporous silica nanostructures (MSNs) in the drug delivery field has shown a significant potential for improving the oral delivery of active pharmaceutical products with low solubility in water. Mirtazapine (MRT) is a tetracyclic antidepressant with poor water solubility (BCS Class II), which was recently approved as a potent drug used to treat severe depression. The principle of this research is to optimize the incorporation of Mirtazapine into MSNs to improve its aqueous solubility, loading efficiency, release performance, and subsequent bioavailability. The formulation was optimized by using of Box-Behnken Design, which allows simultaneous estimation of the impact of different types of silica (SBA-15, MCM-41, and Aluminate-MCM-41), a different drug to silica ratios (33.33%, 49.99%, and 66.66%), and different drug loading procedures (Incipient wetness, solvent evaporation, and solvent impregnation) on the MRT loading efficiency, aqueous solubility and dissolution rate. The optimized formula was achieved by loading MRT into SBA-15 at 33.33% drug ratio prepared by the incipient wetness method, which displayed a loading efficiency of 104.05%, water solubility of 0.2mg/ml, and 100% dissolution rate after 30 min. The pharmacokinetic profile of the optimized formula was obtained by conducting the in-vivo study in rabbits which showed a marked improvement (2.14-fold) in oral bioavailability greater than plain MRT. The physicochemical parameters and morphology of the optimized formula were characterized by; gas adsorption manometry, scanning electron microscopy (SEM), polarized light microscopy (PLM), Fourier-transform infrared spectroscopy (FT-IR), differential scanning calorimetry (DSC), and X-ray powder diffraction (XRPD). [ABSTRACT FROM AUTHOR]

This study was conducted to evaluate the potential nephroprotective effects of febuxostat, mirtazapine, and their combination against gentamicin-induced nephrotoxicity. Induction of nephrotoxicity was achieved via gentamicin injection (100 mg/kg, I.P., for 7 days). Two different doses of mirtazapine (15–30 mg/kg), febuxostat (5–10 mg/kg), and their combination were administered daily for 14 days prior to gentamicin injection and then concomitantly with gentamicin for additional 7 days. Nephrotoxicity was evaluated histopathologically and biochemically. Renal caspase-3, extracellular signal-regulated protein kinase 1/2 (ERK1/2), nuclear factor-kappa-β (NF-κβ), and monocyte chemoattractant protein (MCP-1) were assayed. Febuxostat and mirtazapine significantly (p < 0.05) alleviated biochemical and histopathological alterations that were induced by gentamicin and, for the first time, significantly decreased the renal levels of ERK1/2 and MCP-1. Conclusion: Febuxostat and mirtazapine were found to have a synergistic impact in reducing gentamicin-induced nephrotoxicity. The utility of nonpurine xanthine oxidase inhibitor, such as febuxostat and mirtazapine are offering a new potential opportunity for the future nephroprotective effects therapy: Febuxostat and mirtazapine are found to have a synergistic impact in reducing gentamicin-induced nephrotoxicity. [ABSTRACT FROM AUTHOR]

While mirtazapine is primarily prescribed for major depressive disorder, it is less commonly prescribed for anorexia related to various disease states. Mirtazapine is associated with few adverse events but potential for a discontinuation syndrome does exist. Here we describe a case of a 53-year-old man prescribed mirtazapine 15 mg/day for appetite stimulation who experienced anxiousness, nausea, tremor, loss of appetite, lack of desire for food, and an 8-pound weight loss after abrupt, inadvertent discontinuation. Symptom onset was acute and presented within 48-hours of stopping his medication. Mirtazapine was restarted at the same dose after 14 days of ongoing symptoms and his symptoms subsided immediately. Scant literature exists to highlight the potentially serious adverse events associated with abrupt mirtazapine discontinuation, even at low doses, and this case contributes to advocating for the need of mirtazapine taper when medication cessation is being considered. [ABSTRACT FROM AUTHOR]

Mirtazapine has traditionally been used for the treatment of major depressive disorder, with an added benefit in patients who have comorbid insomnia or anxiety. Recent studies describe its usefulness in treating refractory pruritus of various causes as well. Our goal is to better define the use of mirtazapine in the treatment of refractory pruritus. Through a thorough literature review of PubMed, we identified all reports of the use of mirtazapine for pruritus. Upon examination of 8 supporting articles, we found mirtazapine has quality evidence for the treatment of intra-thecal morphine-induced pruritus. Mirtazapine may also be effective in treating pruritus related to various other conditions, including psoriasis, atopic dermatitis, cutaneous malignancies (primary or metastatic), hematologic malignancies (lymphomas and leukemias), liver failure, renal failure, cholestasis, as well as pruritus of unknown origin. Mirtazapine plays a role in treatment for intra-thecel morphine-induced pruritis yet high-quality trials are needed to confirm its efficacy in other dermatologic conditions. [ABSTRACT FROM AUTHOR]

Objectives: Concurrent abuse of cocaine and nicotine is considered a public health problem. To date, no effective therapy has been known to reduce the reinforcing effects of concurrent use of cocaine and nicotine. Mirtazapine, an antagonist of the α2-adrenoceptor and the 5-HT2A/C and the 5-HT3 receptors has proven effective in reducing the cocaine, nicotine and methamphetamine behavioural effects in humans and animals. Our study evaluated the effect of mirtazapine on enhancing locomotor activity during the induction and expression of locomotor sensitisation induced by a cocaine + nicotine mixture. Methods: Wistar rats were dosed with cocaine, nicotine or cocaine + nicotine combination. Mirtazapine (30 mg/kg, i.p.) was administered during the extinction phase. Results: Mirtazapine decreased cocaine + nicotine-induced locomotor activity and induction and expression of locomotor sensitisation. In addition, we found that co-administration of mecamylamine and mirtazapine significantly enhanced the effect of mirtazapine on cocaine + nicotine-induced locomotor activity during induction and expression of behavioural sensitisation. Conclusions: Our results suggest that mirtazapine demonstrated efficacy in decreasing the psycho-stimulant effects of concurrent use of cocaine and nicotine. [ABSTRACT FROM AUTHOR]

Objectives: Depression is highly prevalent worldwide and generates significant economic burden. Despite this, there is still insufficient information on hospitalisation costs related to depression. Therefore, this paper presents a comparison of costs of inpatient care of depression among patients hospitalised in 2014 in Kiel (Germany) and in Poznan (Poland). Methods: The retrospective study was conducted from October 2015 to May 2017 in Kiel and in Poznan and concerned all patients (n = 548 and eventually included n = 444; 334 in Kiel and 110 in Poznan) hospitalised in these centres. Results: The annual cost of inpatient care of patients hospitalised due to depression in 2014 was EUR x ¯ = EUR 9397.21 (total EUR 313,8667.2) in Kiel and EUR x ¯ = EUR 2962.90 (total EUR 325,919.38) in Poznan. In Kiel, the most frequently prescribed medicine was mirtazapine while in Poznan it was venlafaxine. Conclusions: The 3-fold difference in average costs of hospitalisation might result from differences in funding of mental health care which in Poland needs urgent amendment. Besides, mental health care was underfunded in Poznan. In general, treatment was comprehensive in both centres. Non-pharmacological treatment, however, was more comprehensive in Kiel. The cost of inpatient care of depression was very high both in Kiel and Poznan. Inpatient care of depression is long-lasting, but a reduction in the length of hospital stay seems to be possible. Hospital stay is the main part of costs of inpatient care of depression. Treatment of depression should be comprehensive, but differences e.g. in pharmacotherapy used are possible between hospitals and/or countries. [ABSTRACT FROM AUTHOR]

Objectives: Neuropathic pain reduces the life qualities of patients with Diabetes mellitus. Clinical guidelines recommend relief in diabetic neuropathic pain through the use of some antidepressants, anticonvulsants, opioids as well as capsaicin cream or lidocaine patches. However, since the majority of patients do not or partially respond to current treatments, there is a growing necessity for new drugs increasing the pain relief in patients with diabetes. Therefore, based on the therapeutic potential of antidepressants on neuropathic pain, we investigated the promising antihyperalgesic effect of mirtazapine (MRT) in painful diabetic neuropathy. Methods: Experimental diabetes was induced in rats by single intraperitoneal injection of 55 mg/kg dose of streptozocin (STZ). After 4 weeks of injection of STZ, MRT was administrated for 14 days at 40 mg/kg dose. Randall–Selitto and Hargreaves tests were applied for paw-withdrawal threshold and paw-withdrawal latency measurement. TRPV1 and ASIC1 expressions measured by Western blot in dorsal root ganglion and spinal cord. Results: Administration of MRT significantly improved both of the decreased paw-withdrawal threshold and shortened the paw-withdrawal latency of diabetic rats, respectively. Besides, increased levels of TRPV1 and ASIC1 channels in dorsal root ganglion and spinal cord of diabetic rats, evaluated by Western blot method, were decreased following the MRT treatment. Discussion: These data show, for the first time, that MRT has beneficial effects against diabetes-induced hyperalgesia, and that suppressive effect of this drug on TRPV1 and ASIC1 levels, which are increased in diabetic rats, may be some of the pharmacological mechanisms underlying the exhibited antihyperalgesic effect of MRT. [ABSTRACT FROM AUTHOR]

Cisplatin (CP) is a chemotherapy medication used to treat different types of organs cancers. It has damaging effects on testes. Mirtazapine is an antidepressant, which is used primarily in the treatment of depression and other anxiety disorders. Ginger is a naturally growing plant with antioxidant properties. Thirty-six adult male albino rats, subdivided into six groups (six animals each) received treatment for 30 days. Group I (control) received saline solution orally; group II received mirtazapine (20 mg/kg). Group III received ginger (200 mg/kg/day), group IV received CP (7 mg/kg) IP single dose, at day 23rd, group V received mirtazapine (200 mg/day) orally till day 23rd, CP (7 mg/kg) IP at day 23rd, mirtazapine till day 30th, group VI received ginger (200 mg/Kg/day) orally till day 23rd, CP (7 mg/kg) IP at day 23rd, and then ginger at the previous dose till day 30th. This study examined the microscopic changes associated with CP and the possible testicular protective role of mirtazapine versus ginger of adult male rats. Mirtazapine and ginger resulted in cellular protection of testicular tissue as evident from microscopic changes including Sertoli cells, spermatogonia, and Leydig cells. Ginger showed to have a more protective effect than mirtazapine on testicular tissue against CP treatment. [ABSTRACT FROM AUTHOR]

Introduction: Functional dyspepsia (FD), defined by the Rome consensus as the presence of functional symptoms originating from the gastroduodenum, is one of the most common functional gastrointestinal disorders. FD is subdivided into postprandial distress syndrome (PDS), with meal-related symptoms such as postprandial fullness and early satiation, and epigastric pain syndrome (EPS), with meal-unrelated symptoms such as epigastric pain or burning. We used a literature search for a narrative review on the current state of knowledge regarding PDS. Areas covered: Epidemiological studies support PDS as a separate entity and the biggest FD subgroup. The pathophysiology of PDS is heterogeneous, and disorders of gastric sensorimotor function as well as low grade duodenal inflammation have been implicated. Although prokinetic agents may provide the most pathophysiology-oriented treatment option, there is a paucity of suitable agents, and proton pump inhibitors are the traditional first-line therapy. Other options include agents that enhance gastric accommodation, such as acotiamide and 5-HT1A agonists, neuromodulators such as mirtazapine, and traditional medicine approaches. Expert commentary: PDS is highly prevalent, with probably heterogeneous underlying pathophysiology. Motility modifying agents and neuromodulators are the cornerstone of PDS therapy, but there is a need for high quality studies of new therapeutic approaches. [ABSTRACT FROM AUTHOR]

Introduction: Pharmacological treatment of insomnia in patients with addictions has been hardly investigated and there are few researches about it in an inpatient detoxification. The aim of this study was to describe the outcomes of the pharmacological treatment of insomnia in SUD patients admitted to a detoxification unit in Spain, with a focus on the primary substance of abuse and co-occurring mental disorders. Methods: A quasi-experimental study was conducted in 481 addicted in patients, who were admitted for substances detoxification in Vall d´Hebron University Hospital, Barcelona, Spain, from 2010 to 2015. The patients underwent systematic evaluation of axes I and II psychiatric disorders (SCID-I, SCID-II, and CAADID). Insomnia was evaluated using a night time sleep log. Substance-dependent patients, who had insomnia during hospital detoxification, received a psychotropic medication with hypnotic effect, keeping the regular clinical practice without randomization. Results: At discharge, insomnia was considered to have been alleviated in 63.8% (n = 204) of patients while 36.2% (n = 116) of patients remained with insomnia disturbances. Comparing hypnotic treatments it was observed that mirtazapine and clotiapine were the treatment that corrected the insomnia more frequently. Discussion: Since insomnia is not corrected in all patients, it should be further investigated in medications with hypnotic purpose. Based on the results of this work, randomized clinical trials might be proposed. [ABSTRACT FROM AUTHOR]

Introduction: Orally disintegrating tablets (ODTs) provide an important treatment option for pediatric, geriatric and psychiatric patients. In our previous study, we have performed the initial studies for the formulation development and characterization of new ODT formulations containing a bitter taste drug, mirtazapine, coated with 6% (w/w) Eudragit® E-100 (first group of formulations, FGF) without taste evaluation. In present study, coating ratio of the drug was increased to 8% (w/w) (second group of formulations, SGF) to examine the effect of increased coating ratio of drug on in vitro characterization of the formulations including in vitro taste masking study. Materials and methods: Coacervation technique using Eudragit® E-100 was employed to obtain taste-masked mirtazapine granules. FGF and SGF were compared to original product (Remeron SolTab, an antidepressant drug which produced by pellet technology) in terms of in vitro permeability, in vitro taste masking efficiency which was performed by dissolution studies in salivary medium and dissolution stability. Also, the other tablet characteristics (such as diameter, thickness) of SGF were examined. Results and discussion: The disintegration time of the SGF were found as A1 < A2 < A3 < A5 < A4 (8% Eudragit® E-100), but all of the formulations dissolved under 30 seconds and friability values were less than 1%. In vitro taste masking efficiency studies demonstrated that C2 formulation (in FGF) had the most similar dissolution profile to Remeron SolTab. Conclusions: According to these findings, B2 or C2 (with citric acid or sodium bicarbonate, respectively, with 6% Eudragit® E-100) formulations could be promising alternatives to Remeron SolTab. [ABSTRACT FROM AUTHOR]

Aim:Sexual dysfunction, common in schizophrenia, may be further exaggerated by antipsychotics, especially those of First Generation (FGAs), and antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRs). Mirtazapine, an antidepressant characterized by its different action mechanism compared with that of the majority of other antidepressants, may improve SSRI-induced sexual dysfunction in patients with depression. It is unknown, however, whether mirtazapine improves sexual functioning in schizophrenia. Methods:This study randomly assigned FGA-treated patients with schizophrenia to receive either an add-on mirtazapine (n = 20) or a placebo (n = 19) for 6 weeks. Sexual functioning was prospectively measured using five relevant items from the Udvalg for Kliniske Undersogelser side-effect rating scale (UKU-SERS). Results: Orgasmic function improved with statistical significance in the mirtazapine group (p = .03), with no changes in any other sexual functions in either group. Conclusion:Add-on mirtazapine appears to relieve orgasmic dysfunction in FGA-treated patients with schizophrenia. [ABSTRACT FROM PUBLISHER]

Objective: Orally disintegrating tablets (ODTs) recently have gained much attention to fulfill the needs for pediatric, geriatric, and psychiatric patients with dysphagia. Aim of this study was to develop new ODT formulations containing mirtazapine, an antidepressant drug molecule having bitter taste, by using simple and inexpensive preparation methods such as coacervation, direct compression and to compare their characteristics with those of reference product (Remereon SolTab). Materials and methods: Coacervation method was chosen for taste masking of mirtazapine.In vitrocharacterization studies such as diameter and thickness, weight variation, tablet hardness, tablet friability and disintegration time were performed on tablet formulations. Wetting time andin vitrodissolution tests of developed ODTs also studied using 900 mL 0.1 N HCl medium, 900 mL pH 6.8 phosphate buffer or 900 mL pH 4.5 acetate buffer at 37 ± 0.2 °C as dissolution medium. Results: Ratio of Eudragit® E-100 was chosen as 6% (w/w) since the dissolution profile of A1 (6% Eudragit® E-100) was found closer to the reference product than A2 (4% Eudragit® E-100) and A3 (8% Eudragit® E-100). Group D, E and F formulations were presented better results in terms of disintegration time. Dissolution results indicated that Group E and F formulations showed optimum properties in all three dissolution media. Discussion: Formulations D1, D4, D5, E3, E4, F1 and F5 found suitable as ODT formulations due to their favorable disintegration times and dissolution profiles. Conclusion: Developed mirtazapine ODTs were found promising in terms of showing the similar characteristics to the original formulation. [ABSTRACT FROM PUBLISHER]

The aim of the study was to prepare PLGA microparticles for prolonged release of mirtazapine by o/w solvent evaporation method and to evaluate effects of PVA concentration and organic solvent choice on microparticles characteristics (encapsulation efficiency, drug loading, burst effect, microparticle morphology). Alsoin vitrodrug release tests were performed and the results were correlated with kinetic model equations to approximate drug release mechanism. It was found that dichloromethane provided microparticles with better qualities (encapsulation efficiency 64.2%, yield 79.7%). Interaction between organic solvent effect and effect of PVA concentration was revealed. The prepared samples released the drug for 5 days with kinetics very close to that of zero order (R2 = 0.9549 – 0.9816). According to the correlations, the drug was probably released by a combination of diffusion and surface erosion, enhanced by polymer swelling and chain relaxation. [ABSTRACT FROM AUTHOR]

Remeron (Mirtazapine) is an antidepressant drug which exerts its action by blocking presynaptic α-2-adrenergic receptors and postsynaptic serotonin types 2 and 3 receptors. In thisin vitroanalysis, human peripheral blood lymphocytes was treated by remeron (10, 25, 40 and 55 μg/mL) for 24 hours and 48 hours periods, then it was attempted to study of genotoxic and cytotoxic effects of the substance on human peripheral blood lymphocytes by some tests such as sister chromatid exchange (SCE), chromosomal abnormalities (CA) and micronucleus (MN) tests. Also proliferating effect of the substance was investigated. Remeron didn’t significantly cause chromosomal abnormalities and sister chromatid exchange while caused micronucleus at 40 μg/mL concentration and 24 h periodic time and increased proliferation index of the both 24 and 48 hours treated cells was decreased in a concentration manner. Also, exposing to the remeron for 24 and 48 hours leaded to a decrease in mitotic index and nucleus division index in the cells by concentration dependent manner. These findings showed that remeron did not have significantly genotoxic effects on human peripheral blood lymphocytes while it showed cytotoxic effects on the cells, which is the first report on genotoxic and cytotoxic properties of remeron. [ABSTRACT FROM PUBLISHER]

Aim: The identification of antidepressant drugs (ADs) response biomarkers in depression is of high clinical importance. We explored CHL1 and ITGB3 expression as tentative response biomarkers. Materials & methods: In vitro sensitivity to ADs, as well as gene expression and genetic variants of the candidate genes CHL1, ITGB3 and SLC6A4 were measured in lymphoblastoid cell lines (LCLs) of 58 depressed patients. Results: An association between the clinical remission of depression and the basal expression of CHL1 and ITGB3 was discovered. Individuals whose LCLs expressed higher levels of CHL1 or ITGB3 showed a significantly better remission upon AD treatment. In addition individuals with the CHL1 rs1516338 TT genotype showed a significantly better remission after 5 weeks AD treatment than those carrying a CC genotype. No association between the in vitro sensitivity of LCLs toward AD and the clinical remission could be detected. Conclusion: CHL1 expression in patient-derived LCLs correlated with the clinical outcome. Thus, it could be a valid biomarker to predict the success of an antidepressant therapy. Original submitted 8 December 2014; Revision submitted 2 March 2015 [ABSTRACT FROM AUTHOR]

The article presents a report titled " Comparative efficacy, acceptability, and safety of medicinal, cognitive-behavioral therapy, and placebo treatments for acute major depressive disorder in children and adolescents: a multiple-treatments meta-analysis." Topics discussed include characteristics of trials studying major depressive disorder treatment, efficacy and safety of treatment using venlafaxine, sertraline, and mirtazapine, and efficacy of treatment with combined fluoxetine.

Objective. There is limited information on mirtazapine overdose, but cases of severe effects (seizures, serotonin toxicity and coma) have been reported. We aimed to investigate the clinical effects and complications of mirtazapine overdose. Methods. This was an observational case series of mirtazapine overdoses (> 120 mg) identified from admissions to a toxicology unit between January 1987 and August 2013. Demographic information, details of ingestion, clinical effects, ECG parameters (HR, QT and QRS), and length of stay were extracted from a clinical database. Results. From 267 mirtazapine overdoses, there were 89 single-agent mirtazapine ingestions and 178 cases where mirtazapine was taken with at least one other drug. The median age of the 89 single-agent mirtazapine ingestions was 36 years [interquartile range (IQR): 26-49 years; Range: 15-81 years]; 45 were female (51%). The median ingested dose was 420 mg (IQR: 270-750 mg; Range: 150-1350 mg) and 41 patients (46%) had a Glasgow coma score (GCS) < 15, but the minimum GCS was 10. There were no seizures, serotonin toxicity or delirium. Tachycardia occurred in 29 patients (33%) and hypertension in 32 patients (36%). The median QRS was 80 ms (Range: 80-120 ms) and there were no cases with QT prolongation. There were no arrhythmias and no deaths. The median length of stay was 14 h (IQR: 8.8-18.2 h; Range:2.2-75 h). No single-agent mirtazapine patient was admitted to intensive care. The 178 patients taking co-ingestants had more severe toxicity depending on the co-ingested drug. Conclusion. Mirtazapine appears to be relatively benign in overdose, associated with tachycardia, mild hypertension and mild CNS depression not requiring intervention. [ABSTRACT FROM AUTHOR]

Abstract: Background: Mirtazapine is an antidepressant drug that blocks central 5-HT2 receptors with anxiolytic and sleep-promoting effects and theoretically can be used as a premedication. Methods: Sixty ASA I-II patients aged 25–50yr were randomly allocated according to the premedication received 2h before induction of anesthesia into two equal groups: group M patients received mirtazapine 30mg tablet mixed with 20ml of water and group P patients received 20ml of plain water. Anxiety level was measured by visual analogue scale (VAS) and bispectral index (BIS) electrodes were connected before induction of anesthesia. Intravenous (i.v) infusion of propofol 1% at a rate of 300mlh−1 was started to induce hypnosis till a target BIS value of 45 (BIS45) is reached, and then endotracheal intubation is performed after fentanyl and cis-atracuruim being administered. Propofol dose requirements to achieve loss of response to verbal contact (RVC), loss of eyelash reflex (ELR), and a target BIS45 were recorded. Anesthesia was maintained with sevoflurane titrated to BIS value of 40–50 and oxygen/air mixture. Recovery time was recorded. In postanaesthesia care unit (PACU), VAS for pain and Ramsay sedation score were recorded. Patients were discharged from PACU when two consecutive Aldrete scores of 9 or 10 are obtained, and time of PACU stay was recorded. Results: Preoperative anxiety by VAS and propofol doses required achieving loss of RVC and ELR, and target BIS45 were significantly lower in mirtazapine group. The two groups were comparable with regard to recovery and PACU stay times as well as postoperative pain and anxiety. Conclusion: Mirtazapine 30mg oral tablets can be used as a premedication as it reduces preoperative anxiety and hypnotic dose requirements of propofol, and does not prolong recovery time. [Copyright &y& Elsevier]

Objective: To examine the quality of infant–mother attachment in a prospective case series of infants whose mothers took selective serotonin reuptake inhibitors (SSRIs) during pregnancy. Background: SSRIs are prescribed to 2–6% of pregnant women. Recent articles on the use of SSRIs during pregnancy note the increased risk for problematic infant–mother relationships among mothers with untreated postpartum depression. However, little is known about the quality of infant–mother relationships among mothers who took SSRIs during pregnancy. Methods: Five mothers who took SSRIs during pregnancy were recruited from a community study of infant development. Mothers completed ratings of postpartum depression symptoms (Beck Depression Inventory) 4–6 times between 1 month and 1 year following the infant’s birth. At 1 year postpartum, quality of infant–mother attachment was assessed using the strange situation procedure. Results: Four of the five infant–mother dyads (80%) were classified as disorganised, a rate considerably higher than in postpartum depression samples. Conclusion: These results are used to raise questions about the clinical implications of research on in utero exposure to SSRIs, perinatal depression, and disorganised attachment. Specifically, this case series raises questions about using research on the link between postpartum depression and infant–mother attachment as a rationale for the use of SSRIs during pregnancy. Current research indicates use of SSRIs during pregnancy may: (1) increase risk for disorganised attachment, (2) decrease risk for disorganised attachment, or (3) have no effect on disorganised attachment. [ABSTRACT FROM PUBLISHER]

Objective: This was a first pilot study evaluating the acute phase (8-week) efficacy of the antidepressant medication mirtazapine for the treatment of depressive symptoms and drinking of subjects with comorbid major depressive disorder and alcohol dependence (MDD/AD). We hypothesized that mirtazapine would demonstrate within-group efficacy for the treatment of both depressive symptoms and drinking in these subjects. Methods: We conducted a first open-label study of the second-generation antidepressant mirtazapine in 12 adult outpatient subjects with comorbid MDD/AD. The pharmacological profile of that medication is unique among antidepressants, unrelated to tricyclics or selective serotonin reuptake inhibitors. Results: Mirtazapine was well tolerated in this treatment population. Self-reported depressive symptoms decreased from 31.8 to 8.3 on the Beck Depression Inventory (BDI), a 74.0% decrease (p < .001), and drinking decreased from 33.9 to 13.3 drinks per week, a 60.8% decrease (p < .05). None of the subjects were employed full time at baseline, but 9 of the 12 (75%) were employed full time at the end the of study. Conclusions: These preliminary findings suggest efficacy for mirtazapine for treating both the depressive symptoms and excessive alcohol use of comorbid major depressive disorder and alcohol dependence. Double-blind studies are warranted to further clarify the efficacy of mirtazapine in this population. [ABSTRACT FROM PUBLISHER]

In this study, the effect of mirtazapine on rat kidneys versus ischemia-reperfusion (IR) damage was biochemically and histopathologically investigated. The results have shown that malondialdehyde (MDA) level of healthy rat group is 15.2 mol/g protein. The level of this substance was measured as 26.7 mol/g in only ischemia group. The MDA levels of IR and mirtazapine ++ renal ischemia-reperfusion (MRIR) groups were 39 ± 17.6 mol/g protein. While myeloperoxidase activity of healthy rat group was 20.2 u/g, the activities of only ischemia, IR, and MRIR groups were 28, 36.3, and 21 u/g, respectively. The glutathione levels were measured as 17.7, 12.8, 7.5, and 16.2 nmol/g in healthy, only ischemia, IR, and MRIR groups, respectively. Finally, glutathione S-transferase activities of healthy, only ischemia, IR, and MRIR groups were determined as 20, 13.8, 7.1, and 18.3 u/g, respectively. Histopathologically, while hemorrhage in interstitial area was observed in only ischemia group, significant tubular epithelial swelling, necrosis, and cast accumulation were seen in IR group. In MRIR group, only mild tubular epithelial swelling and mild hyaline cast accumulation were observed in kidney tissue. Consequently, it can be said that mirtazapine has a protective effect on IR-induced kidney damage. [ABSTRACT FROM AUTHOR]

Background. Among the neuroactive steroids, 3α,5α-tetrahydrodeoxycorticosterone (3α,5α-THDOC) is at least in part produced in the adrenal gland and is therefore under the control of the hypothalamic-pituitary-adrenocortical (HPA) system. The antidepressant mirtazapine has been shown to attenuate HPA axis activity and to increase the concentrations of 3α-reduced metabolites of progesterone in depressed patients. In the present study, the impact of mirtazapine on 3α,5α-THDOC levels was investigated in relation to clinical response in depressed patients. Method. A total of 23 drug-free inpatients suffering from a major depressive episode (DSM-IV criteria) underwent 5-week treatment with mirtazapine (45 mg/day). Plasma samples were taken weekly at 08:00 h and were quantified for 3α,5α-THDOC levels. Results. 3α,5α-THDOC levels were not correlated with demographic and clinical parameters such as age and severity of depression. Moreover, 5-week treatment with mirtazapine did not influence the 3α,5α-THDOC in the depressed patients, neither in responders nor in non-responders. Conclusion. Putative increasing effects of mirtazapine on 3α-reduced neuroactive steroids such as 3α,5α-THDOC which may be mediated via an impact on the neurosteroidogenic enzyme 3α-hydroxysteroid dehydrogenase seem to be counterbalanced by the mirtazapine-induced inhibition of ACTH secretion which directly influences the 3α,5α-THDOC release of the adrenal cortex. [ABSTRACT FROM AUTHOR]

Objective. To examine suicidal behaviour risk in the short-term placebo-controlled studies of mirtazapine in Major Depressive Disorder (MDD). Method. Longitudinal Generalized Estimating Equations analyses were performed on pooled data from 15 placebo-controlled, randomized, double-blind, short-term trials of mirtazapine, using the suicide item scores from the Hamilton Depression Rating Scale (HAMD) as a proxy outcome measure for suicidality risk. Results. The overall analysis using the convention that a patient is at risk if the HAMD suicide item score is ≥3, and excluding patients at risk at baseline, demonstrated a statistically significantly lower risk for mirtazapine- compared to placebo-treated patients on the HAMD (odds ratio mirtazapine versus placebo 0.38; 95% confidence interval 0.21-0.66; P= 0.0008). Conclusion. Our results based on pooled data from 15 placebo-controlled, short-term studies of mirtazapine in MDD using the suicide item scores from the HAMD as a proxy outcome measure for suicidality risk, demonstrate that mirtazapine was associated with statistically significantly lower suicidality risk compared to placebo. [ABSTRACT FROM AUTHOR]

Background. The purpose of the present open-label study was to investigate the antidepressant efficacy of lithium and carbamazepine as augmentation strategies in unipolar depressed inpatients. Method. Forty-six patients suffering from unipolar depression (major depressive episode according to DSM-IV criteria) were pre-treated with mirtazapine for 2 weeks initially (week −2 to week 0). Thereafter, the patients received either continuation of mirtazapine monotherapy ( n = 23), combination treatment with mirtazapine and lithium ( n = 13), or combination therapy with mirtazapine and carbamazepine ( n = 10) for further 3 weeks (week 0 to week 3). Severity of depression was estimated weekly using the 21-item version of the Hamilton Depression Rating Scale (21-HAMD). Response was defined by a reduction of at least 50% in the 21-HAMD sum score after 3 weeks of pharmacotherapy (week 0-3). Results. Additional administration of lithium, but not adjunctive carbamazepine significantly augmented the antidepressant efficacy of mirtazapine in the unipolar depressed patients. Moreover, carbamazepine but not lithium significantly lowered the serum concentrations of mirtazapine. Conclusion. Whereas the clinical importance of anticonvulsants in the treatment of bipolar disorder is not in doubt, the therapeutic efficacy of antiepileptic drugs such as carbamazepine is obviously limited in the pharmacotherapy of unipolar depression. [ABSTRACT FROM AUTHOR]

Objective. To assess clinical advantages of fast dissolving tablet (FDT) formulation of mirtazapine by comparison to conventional (CT) mirtazapine tablets in the treatment of depressed patients. Methods. A posteriori analyses of pooled data of a total of 30 studies (of at least 6 weeks duration, total N=3510) with CT and FDT in depressed patients was performed. Weight changes were recorded at baseline and regular intervals until the end of the study. Patient preferences for the one or the other formulation, as well as the appraisal of the FDT qualities, were assessed by means of a global internet-based survey including 5,428 patients. Results. Compared with mirtazapine CT, the FDT was associated with an average 0.3 kg less weight increase (P=0.0015) during the 6 weeks of treatment. The qualities and preference for FDT (global survey) were positively evaluated by the majority of patients. Particular advantages of FDT over CT were: better compliance (47.3% of raters), taste, ease and overall convenience of use (>75% of raters). Conclusions. The FDT mirtazapine differed from conventional tablets (CT) not only regarding somewhat less weight increase and overall use preference, but more importantly, regarding better compliance with treatment. [ABSTRACT FROM AUTHOR]

The effects of mirtazapine, a noradrenergic and specific serotonergic antidepressant, on morphine withdrawal and morphine conditioned place preference (CPP) were investigated in rats. Our results showed that some morphine withdrawal signs, including teeth chattering, grooming, chewing, and escape attendance, were attenuated by single pretreatments with 3, 10, or 30 mg/kg mirtazapine. Wet-dog shakes, rearing, and grooming were inhibited by daily pretreatment with 1, 3, or 10 mg/kg mirtazapine. The expression of morphine-induced CPP was significantly blocked by mirtazapine (10 or 30 mg/kg, i.p.), while chronic treatment with mirtazapine (1 or 10 mg/kg, i.p. once, daily, for six consecutive days) significantly attenuated the acquisition of morphine CPP. Our results demonstrated that mirtazapine attenuates morphine withdrawal and morphine-induced CPP in rats and suggest that mirtazapine may have therapeutic potential in the treatment of opiate dependence. [ABSTRACT FROM AUTHOR]

A quantitative densitometric high performance thin layer chromatography (HPTLC) method was developed for the simultaneous separation and quantification of Mirtazapine and its structurally related impurities. The three different impurities accounting for 3.3% were identified using TLC aluminium plates precoated with silica gel 60 F254 as the stationary phase. The mobile phase consisted of a saturated solution of toluene-acetone-methanol solution (6:2:2 v/v/v) and UV detection by absorbance reflectance at 285 nm facilitated the quantitative identification of the impurities along with the drug molecule. The minimum amount of Mirtazapine that could be authentically detected and quantified was 22.34 ng/spot and 74.47 ng/spot, respectively. The results of the present work showed that scanning densitometric HPTLC with online UV detection was simple, selective, accurate, and proved to be a valuable complementary method for quantitative evaluation of bulk drugs in the presence of their impurities. [ABSTRACT FROM AUTHOR]

Chronic pruritus associated with underlying malignancy can greatly hinder a patient's quality of life. The severity is variable and patients frequently fail traditional first line therapies. We report a patient with diffuse, chronic pruritus secondary to peripheral T Cell Lymphoma (PTCL) who had same day response to mirtazapine after a litany of other agents were unsuccessful. [ABSTRACT FROM AUTHOR]

Objective. The purpose of the present study was to document the experience with the use of a new, fast-dissolving oral tablet (FDT, RemeronSolTab®) of mirtazapine, a NaSSA antidepressant, in the treatment of depressed patients in daily practice in Switzerland. Methods. It was an open, prospective collection of observations in a total of 1121 depressive patients (>18 years old, both sexes). The treatment duration was 8 weeks with assessments after the second and eighth week. Efficacy measures were CGI (seven points) and specific check-lists for the ratings of severity of anxiety and sleep disturbances. At the end of the trial the acceptance (eight-item questionnaire) of the new formulation was recorded too. Results. The results showed that there was highly significant ( P <0.001) and rapid improvement of severity of depression, anxiety and sleep disturbances in the whole population. Subgroup analyses showed that the antidepressant efficacy was independent of gender, initial severity of depression or of the type of depression (first episode, recurrent, chronic depression). The majority of patients (80%) liked at least one of the properties of FDT and, out of 75% of patients having experience with conventional tablet, 50% stated to be better compliant with this new formulation. Conclusion. This report documents the antidepressant efficacy of mirtazapine FDT. The new formulation found good acceptance by the patients. The results also suggest a likelihood of improved compliance with the mirtazapine FDT. [ABSTRACT FROM AUTHOR]

Open studies suggest that mirtazapine has efficacy in panic disorder treatment. We designed an open study that evaluates changes induced by mirtazapine compared with paroxetine in panic disorder. Patients 18–65 years old consecutively referred to a psychiatry liaison service with panic disorder (DSM-IV criteria) were offered either mirtazapine or paroxetine treatment. There were statistically significant reductions from baseline to week 3 and from week 3 to 8 for mirtazapine and paroxetine groups for: number of panic attacks, Beck Anxiety or Depression Inventory (BAI, BDI) Clinical Global Impresion (CGI) of panic disorder severity and CGI of panic disorder response (these variables were evaluated by the patient, the clinician or a blind evaluator). Responders at week 3 (BAI decrease of 50%) were 83% for the mirtazapine group and 84% for the paroxetine group. Responders at week 8 (number of panic attacks equal to 0) were 77% for the mirtazapine group and 73% for the paroxetine group Statistically significant differences between mirtazapine and paroxetine were found for number of panic attacks at weeks 3 and 8 and BAI at week 3, suggesting a faster response for mirtazapine. Responders at week 8 maintained a no recurrence figure of 95% at follow-up 6 months later. Panic disorder either with or without comorbid depression improved in both groups of treatment. Our study supports the hypothesis that mirtazapine has efficacy in the treatment of panic disorder either with or without comorbid depression. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To compare the toxicity of citalopram, venlafaxine, mirtazapine, and nefazadone after overdose. METHODS: Two-year retrospective review of consecutive patients admitted to the toxicology unit of Edinburgh Royal Infirmary. Outcome measure included physiological variables, ECG recordings, peak creatine kinase, development of arrhythmias, seizure, tremor or agitation, and the need for admission to a critical care facility. RESULTS: A total of 225 patients were studied. Venlafaxine was associated with a significantly higher pulse rate (p < 0.0001) and tremor (p = 0.007) than other antidepressants. Citalopram was associated with a significantly longer QT interval on ECG recording (p < 0.0001) but mean QTc durations were not significantly different between all drugs studied. No arrhythmias were recorded. Only venlafaxine and citalopram caused seizures and were associated with the need for admission to Intensive Care, but there was no significant difference between them. CONCLUSIONS: Mirtazapine and nefazadone appear safe in overdose and were associated with minimal features of neurological or cardiovascular toxicity. Citalopram is more likely to cause QT prolongation but other features of cardiovascular toxicity were uncommon. Both citalopram and venlafaxine are proconvulsants. Venlafaxine also causes more frequent features of the serotonin syndrome. [ABSTRACT FROM AUTHOR]

The case of a 15-year-old girl is reported, who suffered from depression and comorbid bulimia nervosa. Her suicidal behaviour worsened with parallel improvement of bulimic symptoms during fluoxetine treatment. These symptoms reversed after the medication was changed to mirtazapine and quetiapine. The small dose of quetiapine was used as an adjunct to the antidepressant treatment, and it resulted in dramatic improvement of mood, cessation of suicidal ideation and return of normal psychosocial functioning. It is suggested that the anti-bulimic effect of fluoxetine is independent of the antidepressant effect. Worsening of suicidal symptoms during fluoxetine treatment warrants a change of antidepressant. Qutiapine may be useful as an adjunct to antidepressants in the management of treatment resistant depression. [ABSTRACT FROM AUTHOR]

Depression is common in patients with advanced, irreversible disease, but it is not normal. Many drugs and morbid states have been associated with depression. Psychotherapy, cognitive therapy, and electroconvulsive therapy, as well as pharmacotherapy may be helpful. The use of antidepressants and psychostimulants to manage depression in terminally ill patients is reviewed. Evaluation instruments that have been used to assess depression in this population are described. Some open research questions are listed. A treatment algorithm, evidence tables, and drug therapy tables which include drug costs are presented. [ABSTRACT FROM PUBLISHER]

Data on the use of a combination of antidepressants during pregnancy are inadequate. This report presents the beneficial effect of low-dose mirtazapine added onto selective serotonin reuptake inhibitors in the treatment of the symptoms of severe nausea, insomnia and loss of appetite accompanying psychiatric disorders during pregnancy, which is an important problem in clinical practice. The psychiatric diagnoses were determined with the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. Assessments were performed with the Clinical Global Impression-Improvement Scale and the 17-item Hamilton Rating Scale for Depression. Further studies should be carried out to confirm the positive effects and safety of an additional low-dose mirtazapine in these cases. [ABSTRACT FROM AUTHOR]

The antidepressant mirtazapine enhances both noradrenergic and serotonergic transmission by blocking α 2- adrenergic presynaptic auto- and heteroreceptors, respectively. We here report on three patients with mood disorders with psychotic features (two cases with depressive and one with bipolar disorder). Treatment with mirtazapine significantly improved not only their depression, but also their delusions. Depressive symptoms were only partially responsive and delusions unresponsive in all three patients to previous antidepressive and/or antipsychotic treatment, and only mirtazapine induced persistent improvement. These clinical cases suggest that mirtazapine can be a valid alternative for patients with depression with psychotic features and partial treatment-resistance. [ABSTRACT FROM AUTHOR]

A correction is presented to the article, "Protective effect of mirtazapine versus ginger against cisplatin-induced testicular damage in adult male albino rats" which was published in a 2019 issue of the periodical.

We report a suicidal ingestion of six cylindrical and four button batteries, in combination with overdosed prescription medicine and smoking of cannabis. [ABSTRACT FROM AUTHOR]