A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Fixed-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder With and Without Anxious Distress
Overview
- Phase
- Phase 3
- Intervention
- Brexpiprazole +ADT
- Conditions
- Depressive Disorder
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Enrollment
- 837
- Primary Endpoint
- Change in the Montgomery-Asberg Depression
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to assess the tolerability, safety, and efficacy of brexpiprazole (2.0 mg/day) as adjunctive therapy in adult subjects with a diagnosis of MDD with and without anxious distress
Detailed Description
The introduction of atypical antipsychotics has created a renewed interest in adjunctive therapy for MDD, particularly for treatment-resistant MDD. Several atypical antipsychotics have been shown to enhance the response to ADT. This is a phase 3, multicenter, randomized, double-blind, placebo-controlled, fixed-dose trial designed to assess the safety and efficacy of brexpiprazole (2.0 mg/day) as adjunctive therapy to an assigned open-label ADT in depressed subjects with and without anxious distress.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and Female subjects between 18-65 years of age, with diagnosis of major depressive disorder with or without anxious distress
- •Current depressive episode must be at least 8 weeks in duration
Exclusion Criteria
- •Subjects with a history of Neuroleptic Malignant Syndrome or Serotonin Syndrome
- •Subjects who report an inadequate response to more than 3 antidepressant treatments in the current episode
- •Subjects with a current Axis I diagnosis of: Delirium, dementia, amnestic or other cognitive disorder, Schizophrenia, schizoaffective disorder, or other psychotic disorder, Bipolar I or II disorder
Arms & Interventions
Brexpiprazole + ADT
Brexpiprazole + ADT
Intervention: Brexpiprazole +ADT
Placebo + ADT
Placebo + ADT
Intervention: Placebo + ADT
Outcomes
Primary Outcomes
Change in the Montgomery-Asberg Depression
Time Frame: From baseline (end of Phase A [Week 8]) to week 14
To assess the change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score from Baseline (End of Phase A \[Week 8\]) to Week 14. The MADRS was utilized as the primary efficacy assessment of the participant's level of depression and was administered utilizing the Structured Interview Guide for the MADRS (SIGMA). The MADRS consisted of 10 items each with 7 defined grades of severity. The rater decided whether the rating lied on predefined scale steps (0, 2, 4, 6) or between them (1, 3, 5). The 10 items were apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score was 60; 0, no symptom; 60, severely affected.
Secondary Outcomes
- Change From End of Phase A to End of Phase B in MADRS Total Score for the Subpopulation With <25% Improvement From Baseline of Phase A to End of Phase A in MADRS Total Score(From baseline (end of Phase A [Week 8]) to week 14)
- Change in the Sheehan Disability Scale (SDS) From Baseline to End of Treatment(From baseline (end of Phase A [Week 8]) to week 14)
- Change From End of Phase A to End of Phase B in MADRS Total Score for the Subpopulations With Anxious Distress as Specified in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V).(From baseline (end of Phase A [Week 8]) to week 14)