Efficacy of Adjunctive Brexpiprazole in Patients with Major Depressive Disorder: A Clinical Overview
| Autor: | Aleksandar Skuban, Michael E. Thase, Catherine Weiss, James Craig Nelson, Peter Zhang, Mary Hobart, Emmanuelle Weiller |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
medicine.medical_specialty
business.industry medicine.disease Placebo Placebo group 03 medical and health sciences Psychiatry and Mental health chemistry.chemical_compound 0302 clinical medicine chemistry Internal medicine Adjunctive treatment medicine Clinical endpoint Major depressive disorder Antidepressant In patient 030212 general & internal medicine Psychiatry business 030217 neurology & neurosurgery Brexpiprazole |
| Zdroj: | Current Psychiatry Reviews. 12:291-301 |
| ISSN: | 1573-4005 |
| Popis: | Objective: To summarize efficacy data from two phase 2 and two phase 3 short-term, multicenter, randomized, double-blind, placebo-controlled studies of brexpiprazole adjunctive to antidepressant treatments (ADTs) in patients with major depressive disorder (MDD) with inadequate response to ADTs. Methods: Patients with MDD who were inadequate responders to 1–3 prior ADTs entered an 8-week single-blind prospective treatment phase on physician-determined ADT. Patients with inadequate response throughout the prospective treatment phase were randomized to receive either placebo or brexpiprazole (phase 2: flexible dosage 0.15–3.0 mg/day; phase 3: fixed-dosages 1, 2, or 3 mg/day) as adjunctive treatment to their ADT. The primary endpoint was change in Montgomery-Asberg Depression Rating Scale (MADRS) total score from baseline to week 6. Results: Phase 2 studies suggested brexpiprazole doses of 1–3 mg/day were effective as an adjunctive therapy. These observations were confirmed across the two phase 3 studies utilizing a pooled placebo group versus brexpiprazole 1, 2, and 3 mg/day and a pooled analysis of all four studies (brexpiprazole 1–3 mg/day). Greater improvements were observed in MADRS total score with brexpiprazole+ADT versus placebo+ADT (1 mg/day, p |
| Databáze: | OpenAIRE |
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