Changes in Metabolic Parameters and Body Weight in Patients With Prediabetes Treated With Adjunctive Brexpiprazole for Major Depressive Disorder: Pooled Analysis of Short- and Long-Term Clinical Studies.

Objective: Certain atypical antipsychotics, while efficacious as adjunctive treatments in major depressive disorder (MDD), are associated with metabolic adverse effects and weight gain. This analysis determined the effect of adjunctive brexpiprazole on metabolic parameters and body weight in adults with MDD and prediabetes (ie, at risk of developing diabetes) based on pooled data from 3 short-term studies and 1 long-term study.Methods: The short-term studies were 6-week, randomized, double-blind, placebo-controlled studies of adjunctive oral brexpiprazole 1-3 mg/d in outpatients with MDD (DSM-IV-TR criteria) and inadequate response to antidepressant treatment, conducted between June 2011 and May 2016. The long-term study was a 26- to 52-week, open-label extension study conducted between October 2011 and May 2017. Prediabetes was defined based on fasting serum glucose and glycated hemoglobin (HbA1c) levels. Shifts in diabetes status and shifts/changes in fasting metabolic parameters and body weight were determined.Results: Most patients receiving adjunctive brexpiprazole maintained their baseline diabetes status in the short term (568/751; 75.6%) and long term (1,919/2,746; 69.9%). The incidence of categorical shifts in fasting metabolic parameters generally did not differ between treatment groups or between prediabetes and non-diabetes subgroups. Mean changes from baseline in metabolic parameters were small in the short term (all < 5 mg/dL) and long term (all < 6 mg/dL, except < 20 mg/dL for triglycerides). Moderate weight gain was observed in the short term (1.5 kg) and long term (3.4-4.1 kg).Conclusions: Adjunctive brexpiprazole had a limited impact on the metabolic profile of patients with MDD, regardless of diabetes status (prediabetes/non-diabetes).Trial Registration: Data used in this post hoc analysis came from studies with ClinicalTrials.gov identifiers NCT01360645, NCT01360632, NCT02196506, and NCT01360866.

Life Engagement Improvement Following Initiation of Brexpiprazole Treatment in Patients with MDD: A Naturalistic, Retrospective Real-World Study.

Purpose: Life engagement encompasses concepts such as life fulfillment, well-being, and participation in meaningful activities, encompassing cognitive, physical, social, and emotional dimensions. Patients with MDD experience impaired functioning across multiple domains of life engagement and have ranked concepts related to life engagement and fulfillment as important predictors of treatment success. Post-hoc analyses of three clinical trials of patients with MDD treated adjunctively with brexpiprazole have reported a significantly greater improvement in life engagement. This study investigated improvements in life engagement among patients with MDD following initiation of brexpiprazole treatment using a real-world dataset. Patients and Methods: Information was extracted from semi-structured clinical notes of the Mental Status Examination (MSE) of patients in a real-world setting to develop an outcome measure for quantifying life engagement of psychiatric patients. Measures of life engagement and its four sub-domains (emotional, physical, social, and cognitive) were calculated at each clinical visit for 624 adult patients with MDD during the 6 months following brexpiprazole initiation. Paired t-tests assessed differences between the index event and time periods within 6 months of the index event. Kaplan-Meier survival analyses were used to quantify the improvement in life engagement scores following brexpiprazole initiation. Results: The study identified 54 clinical features associated with life engagement. Statistically significant improvements were observed from as early as 1 month following brexpiprazole initiation, with 20.6%, 37.9%, and 53.9% of the patients demonstrating improved life engagement scores within 1, 3, and 6 months, respectively. The improvements were particularly apparent for the emotional and social sub-domains. Conclusion: The results of this study provide evidence of improved life engagement following brexpiprazole initiation in a real-world dataset.

Antipsychotic-Related Stigma and the Impact on Treatment Choices: A Systematic Review and Framework Synthesis.

BACKGROUND: Antipsychotics are a class of medications primarily used to treat individuals with psychotic disorders. They have also been indicated for patients with other psychiatric conditions, such as post-traumatic stress disorder and major depressive disorder. Non-adherence is prominent amongst individuals prescribed antipsychotics, with medication-related self-stigma and social stigma identified as major factors. No previous reviews have focused on stigma associated specifically with antipsychotic medication. This systematic literature review aimed to synthesise evidence on the prevalence of stigmatising attitudes and behaviours related to antipsychotic treatment and understand their impact on antipsychotic treatment initiation and continuation. METHODS: Two independent reviewers screened studies from databases, congress proceedings, ClinicalTrials.gov, and PsychU.org; relevant studies reported quantitative or qualitative data on antipsychotic-related stigma in adults with psychotic disorders, mood disorders, borderline personality disorder or anxiety disorders, or healthcare providers or caregivers of these patients, and any impact on treatment. Framework synthesis facilitated extraction and synthesis of relevant information; quantitative and qualitative data were coded and indexed against a pre-specified thematic framework by two independent reviewers. RESULTS: Forty-five articles reporting on 40 unique studies were included; 22 reported quantitative data, 16 reported qualitative data, and two reported quantitative and qualitative data relating to antipsychotic-related stigma. Framework synthesis identified four themes: 1) impact of antipsychotic treatment on a) social stigma or b) self-stigma; 2) impact of side effects of antipsychotic treatment on a) social stigma or b) self-stigma; 3) impact of route of administration of antipsychotic treatment on stigma; 4) impact of stigma on the use of antipsychotics. CONCLUSION: This systematic literature review found that antipsychotic-related social and self-stigma is a factor in non-adherence to antipsychotics. Further research should examine stigma in a wider range of patients and the extent to which clinicians' treatment decisions are impacted by the potential stigma associated with antipsychotic medications.