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2. C-QUALITY: cost and quality-of-life pharmacoeconomic analysis of antidepressants used in major depressive disorder in the regional Italian settings of Veneto and Sardinia

Author

Mencacci C, Aguglia E, Biggio G, Cappellari L, Di Sciascio G, Fagiolini A, Maina G, Tortorella A, Katz P, and Ripellino C

Subjects
Medicine (General), R5-920, Therapeutics. Pharmacology, RM1-950
Abstract

Claudio Mencacci,1 Eugenio Aguglia,2 Giovanni Biggio,3 Lodovico Cappellari,4 Guido Di Sciascio,5 Andrea Fagiolini,6 Giuseppe Maina,7 Alfonso Tortorella,8 Pablo Katz,9 Claudio Ripellino9 1Department of Mental Health, Fatebenefratelli Hospital, Milan, 2Department of Clinical and Molecular Biomedicine, University of Catania, Catania, 3Department of Experimental Biology and Center of Excellence for the Neurobiology of Drug Dependence, University of Cagliari, Calgiari, 4Department of Mental Health, Camposampiero Hospital, Padova, 5Department of Psychiatry, Policlinico Hospital, Bari, 6Department of Molecular Medicine, University of Siena and Department of Mental Health, University of Siena Medical Center, Siena, 7Department of Neurosciences, University of Torino, Torino, 8Department of Mental Health, University of Naples SUN, Naples, 9CSD Medical Research Srl, Milan, Italy Background: Major depression is a commonly occurring, seriously impairing, and often recurrent mental disorder. Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) are the treatments most commonly used for major depressive disorder. The objective of this study was to assess the cost-effectiveness of SSRIs and SNRIs in the treatment of major depressive disorder in two Italian regional settings, ie, Veneto and Sardinia. Methods: A decision analytic model was adapted from the Swedish Dental and Pharmaceutical Benefits Agency to reflect current clinical practice in the treatment of major depressive disorder in the most significant Italian regions. This adaptation was possible as a result of collaboration with an expert panel of Italian psychiatrists and health economists. The population comprised patients with a first diagnosis of major depressive disorder and initiating one SSRI or SNRI drug for the first time. The time frame used was 12 months. Efficacy and utility data for the model were retrieved from the literature and validated by the expert panel. Local data were used for resource utilization and for treatment costs based on the perspective of each regional health service. Scenario analyses and probabilistic sensitivity analyses were performed to test the robustness of the model. Results: Base case analysis showed that escitalopram is associated with the largest health gain (in quality-adjusted life years) and a lower total cost at one year for Sardinia (except for sertraline, against which it was cost-effective) and for Veneto, and therefore dominates the other treatment strategies, given that more quality-adjusted life years are achieved at a lower total cost. Scenario analyses and probabilistic sensitivity analyses support the robustness of the model. Conclusion: The results indicate that escitalopram is the most cost-effective pharmacologic treatment strategy for both regional health services compared with all SSRIs and all SNRIs used in the first-line treatment of major depressive disorder. Keywords: antidepressants, major depressive disorder, cost-effectiveness quality of life, Italy

Published
2013

3. Insomnia evaluation and treatment during peripartum: a joint position paper from the European Insomnia Network task force 'Sleep and Women,' the Italian Marcè Society and international experts task force for perinatal mental health

Author

Palagini, L., Bramante, A., Baglioni, C., Tang, N., Grassi, L., Altena, E., Johann, A. F., Geoffroy, P. A., Biggio, G., Mencacci, C., Sharma, V., and Riemann, D.

Subjects
Treatment, Cognitive behavioral therapy for insomnia (CBT-I), Insomnia, Pregnancy, Socio-culturale, Evaluation, Peripartum
Published
2022

7. Cognitive function modulation during aging: a focus on L-alpha-GPE

Author

Biggio, G., Di Fazio, I., and Martini, C.

Subjects
Aging, Cognition, Nootropics, Memory, Mild cognitive impairment, Neuronal plasticity, Phosphatidylethanolamines, Humans, Cognitive Dysfunction, Nootropic Agents
Abstract

The objectives of this review are to explore the neuronal pathways and cellular and molecular mechanisms involved in both healthy and impaired cognitive function and to discuss the role of nootropics, in particular, those with cholinergic activity, as promising interventions to preserve and/or improve cognitive performance in patients in the symptomatic pre-dementia stage, known as mild cognitive impairment (MCI).Papers were retrieved by a PubMed search, using different combinations of keywords (e.g., cognitive function AND aging AND nootropics), without limitations in terms of publication date or language.Nootropics modulate the activities of specific brain pathways involving neurotransmitters and neuromodulators that have distinct roles in the cognitive processes. The nootropic L-a-glyceryl-phosphoryl-ethanolamine (L-a GPE), by virtue of its action as a phospholipid (PL) precursor and acetylcholine (Ach) donor, targets neural stem cell aging, cholinergic depletion, oxidative stress and microglia activation, loss of entorhinal cortex neurons, and reduced hippocampal volume. Cognitive reserve levels may be linked to the resilience and adaptability of the brain to cope with age-related cognitive decline. L-a GPE may contribute to cognitive reserve preservation via its neuronal well-being promoting action.The substantial burden of age-related cognitive decline demands effective long-term and well-tolerated interventions aimed at maximizing the span of effective functioning. The use of inappropriate medication may lower cognitive reserve, thus hastening the onset of symptomatic AD, while the use of nootropics, such as L-a GPE may contribute to cognitive reserve preservation via its neuronal well-being promoting action.

Published
2021

9. Evaluation and management of insomnia in clinical practice and in the time of CoViD-19 in Italy. Expert consensus and task-force recommendations from five scientific societies [Valutazione e trattamento dell'insonnia nella pratica clinica e ai tempi di CoViD-19 in Italia. Raccomandazioni del panel di esperti e della task-force integrata di cinque società scientifiche]

Author

Palagini, L., Manni, R., Aguglia, E., Amore, M., Brugnoli, R., Girardi, P., Grassi, L., Mencacci, C., Plazzi, G., Minervino, A., Nobili, L., and Biggio, G.

Subjects
trattamento, receptors, melatonin, pratica clinica, epidemics, NO, antidepressive agents, societies, valutazione, sleep initiation and maintenance disorders, sonno e covid-19, italy, middle aged, pharmaceutical, scientific, raccomandazioni degli esperti, sonno, humans, hypnotics and sedatives, insonnia, insonnia, valutazione, trattamento, raccomandazioni degli esperti, pratica clinica, sonno, CoViD-19, cognitive behavioral therapy, aged, sars-cov-2, covid-19, consensus, Antidepressive Agents, SARS-CoV-2, COVID-19, Cognitive Behavioral Therapy, GABA Agonists, Hypnotics and Sedatives, Sleep Initiation and Maintenance Disorders, sleep aids, gaba agonists
Published
2020

21. Role of brain allopregnanolone in the plasticity of gamma-aminobutyric acid type A receptor in rat brain during pregnancy and after delivery

Author

Concas, A., Mostallino, M.C., Porcu, P., Follesa, P., Barbaccia, M.L., Trabucchi, M., Purdy, R.H., Grisenti, P., and Biggio, G.

Subjects
Brain -- Physiological aspects, GABA -- Research, Neuroplasticity -- Physiological aspects, Pregnancy -- Physiological aspects, Puerperium -- Physiological aspects, Rats -- Physiological aspects, Science and technology
Abstract

The relation between changes in brain and plasma concentrations of neurosteroids and the function and structure of [Gamma]-aminobutyric acid type A ([GABA.sub.A]) receptors in the brain during pregnancy and after delivery was investigated in rats. In contrast with plasma, where all steroids increased in parallel, the kinetics of changes in the cerebrocortical concentrations of progesterone, allopregnanolone (AP), and allotetrahydrodeoxycorticosterone (THDOC) diverged during pregnancy. Progesterone was already maximally increased between days 10 and 15, whereas AP and allotetrahydrodeoxycorticosterone peaked around day 19. The stimulatory effect of muscimol on 36[Cl.sup.-] uptake by cerebrocortical membrane vesicles was decreased on days 15 and 19 of pregnancy and increased 2 days after delivery. Moreover, the expression in cerebral cortex and hippocampus of the mRNA encoding for [Gamma]2L [GABA.sub.A] receptor subunit decreased during pregnancy and had returned to control values 2 days after delivery. Also [Alpha]1,[Alpha]2, [Alpha]3, [Alpha]4, [Beta]1 [Beta]2,[Beta]3, and [Gamma]2S mRNAs were measured and failed to change during pregnancy. Subchronic administration of finasteride, a 5[Alpha]-reductase inhibitor, to pregnant rats reduced the concentrations of AP more in brain than in plasma as well as prevented the decreases in both the stimulatory effect of muscimol on 36[Cl.sup.-] uptake and the decrease of [Gamma]2L mRNA observed during pregnancy. These results indicate that the plasticity of [GABA.sub.A] receptors during pregnancy and after delivery is functionally related to fluctuations in endogenous brain concentrations of AP whose rate of synthesis/metabolism appears to differ in the brain, compared with plasma, in pregnant rats.

Published
1998

41. Prescribing pattern of antipsychotic drugs in the Italian general population 2000-2005: A focus on elderly with dementia

Author

Trifiro, G, Sini, G, Sturkenboom, M, Vanacore, N, Mazzaglia, G, Caputi, A, Cricelli, C, Brignoli, O, Aguglia, E, Biggio, G, Samani, F, Trifiro G, Sini G, Sturkenboom MCJM, Vanacore N, Mazzaglia G, Caputi AP, Cricelli C, Brignoli O, Aguglia E, Biggio G, Samani F, Trifiro, G, Sini, G, Sturkenboom, M, Vanacore, N, Mazzaglia, G, Caputi, A, Cricelli, C, Brignoli, O, Aguglia, E, Biggio, G, Samani, F, Trifiro G, Sini G, Sturkenboom MCJM, Vanacore N, Mazzaglia G, Caputi AP, Cricelli C, Brignoli O, Aguglia E, Biggio G, and Samani F

Abstract

The objective of this study was to evaluate the antipsychotic drug prescribing pattern in the Italian general population, elderly, and especially elderly with dementia, in relation to the safety warnings issued by international regulatory agencies about the risk of cerebrovascular adverse events and mortality in 2004 and 2005. A cohort study was conducted using the electronic medical records of the Italian general practice database 'Health Search/Thales'. On the basis of prescription data, 1-year and monthly prevalence estimates were calculated for atypical and typical antipsychotic use in general population, elderly, and elderly demented outpatients. One-year prevalence of individual medication use in elderly demented patients was calculated as well. The prevalence of use of atypical agents in demented patients progressively increased from 2000 [0.2 (0.05-0.7) per 10000] until the beginning of 2004 [9.7 (8.1-11.6) per 10000], after which a slight decrease started, whereas the prevalence of use of typical antipsychotics decreased from 2001 [15.7 (13.5-18.2) per 10000] until 2004 [10.7 (9.0-12.7) per 10000], then slightly increased in December 2005 [12.1 (10.4-14.2) per 10000]. Monthly trends in general population and elderly were quite similar and differed significantly from the trend in elderly with dementia: stable use of atypicals from 2002 to 2005 and strong reduction of typicals from 2001 to the end of 2004. The recent safety warnings led to an increasing trend in the use of typical agents and decreasing trend in the use of atypical agents in elderly demented outpatients in Italy. Similar trends were not observed in general population and elderly as a whole. Int Clin Psychopharmacol 25:22-28 (C) 2010 Wolters Kluwer Health vertical bar Lippincott Williams & Wilkins.

Published
2010

42. Differential modulation of GABA(A) receptor function by aryl pyrazoles

Author

Mascia, M.P., Ledda, G., Orrù, A., Marongiu, A., Loriga, G., Maciocco, E., Biggio, G., and Ruiu, S.

Subjects
Benzodiazepines, GABAA receptor, Aryl pyrazoles
Abstract

Several aryl pyrazoles characterized by a different molecular structure (flexible vs constrained), but chemically related to rimonabant and AM251, were tested for their ability to modulate the function of recombinant ?1?2?2L GABAA receptors expressed in Xenopus laevis oocytes. The effects of 6Bio-R, 14Bio-R, NESS 0327, GP1a and GP2a (0.3-30 ?M) were evaluated using a two-electrode voltage-clamp technique. 6Bio-R and 14Bio-R potentiated GABA-evoked Cl(-) currents. NESS 0327, GP1a and GP2a did not affect the GABAA receptor function, but they acted as antagonists of 6Bio-R. Moreover, NESS 0327 inhibited the potentiation of the GABAA receptor function induced by rimonabant. The benzodiazepine site seems to participate in the action of these compounds. In fact, flumazenil antagonized the potentiation of the GABAA receptor induced by 6Bio-R, and NESS 0327 reduced the action of lorazepam and zolpidem. On the contrary, NESS 0327 did not antagonize the action of "classic" GABAergic modulators (propanol, anesthetics, barbiturates or steroids). In ?1?2 receptors 6Bio-R potentiated the GABAergic function, but flumazenil was still able to antagonize the potentiation induced by 6Bio-R. Aryl pyrazole derivatives activity at the GABAA receptor depends on their molecular structure. These compounds bind to both an ??? binding site, and to an ?/? site which do not require the ? subunit and that may provide structural leads for drugs with potential anticonvulsant effects.

Published
2014

43. Italian Study on Depressive Disorders (STudio Italiano MAlattia Depressiva, or STIMA-D): a nationwide snapshot of the status of treatment for major depression

Author

Aguglia, E, Biggio, G, Signorelli, Ms, Mencacci, C, Investigators: Aguglia E, Steering Committee on behalf of the STIMA D., Minutolo, G, Altamura, A, Buoli, M, Balestrieri, M, Ciano, R, Amadè, E, Barbera, S, Bellantuono, C, Tofani, S, Bellomo, A, De Salvia ML, Bersani, G, Manuali, G, Bogetto, F, Albert, U, Carpiniello, B, Pinna, F, Ceglie, R, Simonini, E, Clerici, M, D'Urso, N, Di Sciascio, G, Palumbo, C, Fagiolini, A, Goracci, A, Nuvoli, G, Luise, L, Furlan, Pm, Picci, Rl, Guazzelli, M, Janiri, L, Bruschi, A, Barbera, D, Mulè, A, Marchetti, Fp, Corretti, G, Mauri, M, Giunti, I, Mautone, A, Cerruti, C, Sironi, J, Mencarelli, L, Squillacioti, Mr, Nicotera, M, Suffredini, E, Pallanti, S, Cecchelli, C, Placidi, G, Rossi, M, Quartesan, R, Moretti, P, Rabboni, M, Tancredi, F, Rinaudo, C, Roncone, Rita, Malavolta, M, Faletta, O, Avola, V, Scapati, F, Giardina, G, Sciarretta, A, Fonso, T, Starace, F, Viparelli, G, Zeppegno, P, Prosperini, P, Torta, R, Amodeo, L, Venanzini, R, Melchiorre, M, Vender, S, Diurni, M, Verrienti, P, Stoppelli, N, Vita, A, Conte, G, Paradisi, R, Pedrolli, P, Boccara, P, Caselli, A., Aguglia, E, Minutolo, G, Altamura, A, Buoli, M, Balestrieri, M, Ciano, R, Amadè, E, Barbera, S, Bellantuono, C, Tofani, S, Bellomo, A, De Salvia, Ml, Bersani, G, Manuali, G, Bogetto, F, Albert, U, Carpiniello, B, Pinna, F, Ceglie, R, Simonini, E, Clerici, M, D'Urso, N, Di Sciascio, G, Palumbo, C, Fagiolini, A, Goracci, A, Nuvoli, G, Luise, L, Furlan, Pm, Picci, Rl, Guazzelli, M, Janiri, L, Bruschi, A, Barbera, D, Mulè, A, Marchetti, Fp, Corretti, G, Mauri, M, Giunti, I, Mautone, A, Cerruti, C, Mencacci, C, Sironi, J, Mencarelli, L, Squillacioti, Mr, Nicotera, M, Suffredini, E, Pallanti, S, Cecchelli, C, Placidi, G, Rossi, M, Quartesan, R, Moretti, P, Rabboni, M, Tancredi, F, Rinaudo, C, Roncone, R, Malavolta, M, Faletta, O, Avola, V, Scapati, F, Giardina, G, Sciarretta, A, Fonso, T, Starace, F, Viparelli, G, Zeppegno, P, Prosperini, P, Torta, R, Amodeo, L, Venanzini, R, Melchiorre, M, Vender, S, Diurni, M, Verrienti, P, Stoppelli, N, Vita, A, Conte, G, Paradisi, R, Pedrolli, P, Boccara, P, Caselli, A, Aguglia E, Minutolo G, Altamura A, Buoli M, Balestrieri M, Ciano R, Amadè E, Barbera S, Bellantuono C, Tofani S, Bellomo A, De Salvia ML, Bersani G, Manuali G, Bogetto F, Albert U, Carpiniello B, Pinna F, Ceglie R, Simonini E, Clerici M, D'Urso N, Di Sciascio G, Palumbo C, Fagiolini A, Goracci A, Nuvoli G, Luise L, Furlan PM, Picci RL, Guazzelli M, Janiri L, Bruschi A, Barbera D, Mulè A, Marchetti FP, Corretti G, Mauri M, Giunti I, Mautone A, Cerruti C, Mencacci C, Sironi J, Mencarelli L, Squillacioti MR, Nicotera M, Suffredini E, Pallanti S, Cecchelli C, Placidi G, Rossi M, Quartesan R, Moretti P, Rabboni M, Tancredi F, Rinaudo C, Roncone R, Malavolta M, Faletta O, Avola V, Scapati F, Giardina G, Sciarretta A, Fonso T, Starace F, Viparelli G, Zeppegno P, Prosperini P, Torta R, Amodeo L, Venanzini R, Melchiorre M, Vender S, Diurni M, Verrienti P, Stoppelli N, Vita A, Conte G, Paradisi R, Pedrolli P, Boccara P, and Caselli A

Subjects
Male, Pediatrics, Treatment outcome, Patient characteristics, major deression, Adolescent, Adult, Age Factors, Aged, Antidepressive Agents, Depressive Disorder, Major, Female, Humans, Italy, Middle Aged, Physicians, Quality of Life, Serotonin Agents, Young Adult, Treatment Outcome, sideffect, Pharmacology (medical), Young adult, Family history, relapse, General Medicine, Psychiatry and Mental health, antidepressants, Anxiety, epidemiology, Major depression, antidepressants, relapse, side-effects, Adolescent, Adult, Age Factors, Aged, Antidepressive Agents, therapeutic use, Depressive Disorder, Major, drug therapy/epidemiology/psychology, Female, Humans, Italy, epidemiology, Male, Middle Aged, Physicians, psychology, Quality of Life, Serotonin Agents, therapeutic use, Treatment Outcome, Young Adult, medicine.symptom, medicine.medical_specialty, major depression, side-effects, sideffects, psychology, Cost burden, Pharmacotherapy, medicine, Psychiatry, Depressive Disorder, antidepressant, business.industry, antidepressants, major depression, relapse, side-effects, Major depression, Antidepressants, Relapse, Side-effects, medicine.disease, Mood disorders, therapeutic use, drug therapy/epidemiology/psychology, business
Abstract

Introduction: Major depression is a worldwide problem and often remains undetected and untreated. Given the low rates of detection plus the need to intervene in a short time, it is important to identify factors which are likely to improve treatment outcomes. Methods: STIMA-D was designed to provide the profile of patients with major depression in Italy (focusing on pathway to care, patient characteristics, drug therapy and treatment outcomes). The patients enrolled (M/F, aged between 18 and 65) experienced single/multiple episodes of major depression (DSM-IV-TR). Patients with lifetime or current bipolar syndrome or other mental disorders were excluded. Results: 44 of the 50 invited centers sent data concerning 1 140 patients. The majority of patients were women. Among working individuals, 52.5% of them were absent from work due to depression in the previous 6 months. Recurrent episodes of major depression were very common and were associated with persistence of residual post-episodic symptoms, a family history of mood disorders and presence of anxiety. 59.6% of the patients were treated with monotherapy (SSRI or SNRI), while 19.2% of them were treated with SSRI plus SNRI. Only the 25.5% on monotherapy had a complete response compared to 12.4% of patients on dual therapy. Discussion: Poor outcomes in major depression have profound implications on patients’ quality of life and cost burden. New pharmacological approaches with novel modes of action are therefore urgently needed.

Published
2014

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