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Major depressive disorder is a complex heterogeneous disorder. Treatment is especially challenging for patients with "difficult-to-treat depression" (DTD): a less stigmatizing and more clinically relevant framework defining depression that continues to cause significant burden despite usual treatment efforts. RESTORE-LIFE is a prospective, observational, multicenter, post-market study being conducted in Europe and is designed to reflect real-world clinical application of adjunctive Vagus Nerve Stimulation Therapy (VNS) for DTD. Baseline characteristics of RESTORE-LIFE patients were analyzed and compared to published treatment-resistant depression (TRD) trials. This analysis includes the initial 98 RESTORE-LIFE patients who commenced treatment with VNS. Patients had a mean of 11.4 failed anti-depressant treatments, 1.1 suicide attempts, 87 % had prior electroconvulsive therapy, and 36 % had an endocrine/metabolic comorbidity. On average, disease severity was comparable to that in TRD trials (n = 15,463). However, RESTORE-LIFE patients appear to have been experiencing DTD for a longer duration and their DTD was characterized by a lack of positive mental health and meaningfulness of life, to a greater degree than by excess of negative mood. Despite high comorbidity rates in RESTORE-LIFE, VNS implantation was performed safely with no discontinuations due to surgical adverse events. RESTORE-LIFE enrolls any patient receiving adjunctive VNS for DTD. Prescription of VNS may be biased by differences in practices amongst sites and countries. The present analysis offers insight into contemporary real-world use of VNS Therapy for DTD in Europe representing a comprehensive characterization of DTD and how this population may differ from those in the TRD literature. • Baseline profile of initial 98 patients in RESTORE-LIFE compared with a review of 15,463 patients from 115 published TRD trials. • RESTORE-LIFE patients have comparable disease severity but potentially longer disease duration than TRD trials' average. • RESTORE-LIFE patients had a mean of 11.4 prior failed antidepressants and 1.1 suicide attempts; and 87 % received prior electroconvulsive therapy (ECT). • Psychiatric, metabolic, and cardiovascular comorbidities were frequent in RESTORE-LIFE patients. • VNS implants were performed safely in RESTORE-LIFE patients with no discontinuations due to surgical adverse events. [ABSTRACT FROM AUTHOR]

One in eight individuals worldwide lives with a mental health disorder. For many European countries, the prevalence is even higher, with one in four people reporting mental health problems [1]. Three-quarters of all mental health disorders develop before age 25, with many presenting initially in undiagnosed forms already in the mid-teens and eventually manifesting as severe disorders and lasting into old age [2]. There is also growing evidence that mental health disorder symptoms cross diagnoses and people frequently have more than one mental health disorder [3].

Background: Major depressive disorder (MDD) is highly prevalent across Europe. While evidence-based treatments exist, many people with MDD have their condition undetected and/or untreated. This study aimed to assess the cost-effectiveness of reducing treatment gaps using a modeling approach., Methods: A decision-tree model covering a 27-month time horizon was used. This followed a care pathway where MDD could be detected or not, and where different forms of treatment could be provided. Expected costs pertaining to Germany, Hungary, Italy, Portugal, Sweden, and the UK were calculated and quality-adjusted life years (QALYs) were estimated. The incremental costs per QALY of reducing detection and treatment gaps were estimated., Results: The expected costs with a detection gap of 69% and treatment gap of 50% were €1236 in Germany, €476 in Hungary, €1413 in Italy, €938 in Portugal, €2093 in Sweden, and €1496 in the UK. The incremental costs per QALY of reducing the detection gap to 50% ranged from €2429 in Hungary to €10,686 in Sweden. The figures for reducing the treatment gap to 25% ranged from €3146 in Hungary to €13,843 in Sweden., Conclusions: Reducing detection and treatment gaps, and maintaining current patterns of care, is likely to increase healthcare costs in the short term. However, outcomes are improved, and reducing these gaps to 50 and 25%, respectively, appears to be a cost-effective use of resources.

Background: Major depressive disorder (MDD) is a leading cause of disability worldwide, and yet delivery of care for this illness is rife with gaps. The COVID-19 pandemic has had far reaching implications for every facet of healthcare, and MDD is no exception. This scoping review aimed to ascertain the impacts of COVID-19 on the delivery of MDD care in Europe, as well as to evaluate any novel MDD care strategies trialled in this period., Methods: We searched the PubMed and PsycINFO databases up to January 2022 with a strategy centred around COVID-19 and MDD. Full texts of eligible studies examining working-age adults and conducted in Europe were evaluated against several criteria. All outcomes were then extracted and a narrative synthesis was constructed to summarise identified themes., Results: Of 1,744 records identified in our search, 11 articles were eligible for inclusion in the review. In general, these studies reported a decrease in treatment rates, access to care, and perceived access to care during the COVID-19 pandemic. In addition, digital interventions trialled during the pandemic were broadly well-received by users, though their efficacy in improving MDD care was ambiguous., Conclusions: Despite a limited number of pertinent studies, this scoping review identified a trend of exacerbated treatment gaps in MDD care during the pandemic. Several of our pre-specified gaps, including delays to detection or treatment of depression and rates of follow-up contacts, remained unexplored in the context of COVID-19. This highlights the need for further investigation to obtain a full understanding of the relationship between COVID-19 and MDD care in Europe.

Objective: To estimate the frequency of mixed states in patients diagnosed with major depressive episode (MDE) according to conceptually different definitions and to compare their clinical validity., Method: This multicenter, multinational cross-sectional Bipolar Disorders: Improving Diagnosis, Guidance and Education (BRIDGE)-II-MIX study enrolled 2,811 adult patients experiencing an MDE. Data were collected per protocol on sociodemographic variables, current and past psychiatric symptoms, and clinical variables that are risk factors for bipolar disorder. The frequency of mixed features was determined by applying both DSM-5 criteria and a priori described Research-Based Diagnostic Criteria (RBDC). Clinical variables associated with mixed features were assessed using logistic regression., Results: Overall, 212 patients (7.5%) fulfilled DSM-5 criteria for MDE with mixed features (DSM-5-MXS), and 818 patients (29.1%) fulfilled diagnostic criteria for a predefined RBDC depressive mixed state (RBDC-MXS). The most frequent manic/hypomanic symptoms were irritable mood (32.6%), emotional/mood lability (29.8%), distractibility (24.4%), psychomotor agitation (16.1%), impulsivity (14.5%), aggression (14.2%), racing thoughts (11.8%), and pressure to keep talking (11.4%). Euphoria (4.6%), grandiosity (3.7%), and hypersexuality (2.6%) were less represented. In multivariate logistic regression analysis, RBDC-MXS was associated with the largest number of variables including diagnosis of bipolar disorder, family history of mania, lifetime suicide attempts, duration of the current episode > 1 month, atypical features, early onset, history of antidepressant-induced mania/hypomania, and lifetime comorbidity with anxiety, alcohol and substance use disorders, attention-deficit/hyperactivity disorder, and borderline personality disorder., Conclusions: Depressive mixed state, defined as the presence of 3 or more manic/hypomanic features, was present in around one-third of patients experiencing an MDE. The valid symptom, illness course and family history RBDC criteria we assessed identified 4 times more MDE patients as having mixed features and yielded statistically more robust associations with several illness characteristics of bipolar disorder than did DSM-5 criteria., (© Copyright 2015 Physicians Postgraduate Press, Inc.)

Context: Major depressive disorder, the most common psychiatric illness, is often chronic and a major cause of disability. Many patients with major depressive episodes who have an underlying but unrecognized bipolar disorder receive pharmacologic treatment with ineffective regimens that do not include mood stabilizers., Objective: To determine the frequency of bipolar disorder symptoms in patients seeking treatment for a major depressive episode., Design: Multicenter, multinational, transcultural, cross-sectional, diagnostic study. The study arose from the initiative Bipolar Disorders: Improving Diagnosis, Guidance and Education (BRIDGE)., Setting: Community and hospital psychiatry departments., Patients: Participants included 5635 adults with an ongoing major depressive episode., Main Outcome Measures: The frequency of bipolar disorder was determined by applying both DSM-IV-TR criteria and previously described bipolarity specifier criteria. Variables associated with bipolarity were assessed using logistic regression., Results: A total of 903 patients fulfilled DSM-IV-TR criteria for bipolar disorder (16.0%; 95% confidence interval, 15.1%-17.0%), whereas 2647 (47.0%; 95% confidence interval, 45.7%-48.3%) met the bipolarity specifier criteria. Using both definitions, significant associations (odds ratio > 2; P < .001) with bipolarity were observed for family history of mania/hypomania and multiple past mood episodes. The bipolarity specifier additionally identified significant associations for manic/hypomanic states during antidepressant therapy, current mixed mood symptoms, and comorbid substance use disorder., Conclusions: The bipolar-specifier criteria in comparison with DSM-IV-TR criteria were valid and identified an additional 31% of patients with major depressive episodes who scored positive on the bipolarity criteria. Family history, illness course, and clinical status, in addition to DSM-IV-TR criteria, may provide useful information for physicians when assessing evidence of bipolarity in patients with major depressive episodes. Such an assessment is recommended before deciding on treatment.