Phase 3
N=837
Study 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
Depressive Disorder · Depression · Depressive Disorder, Major · Mood Disorders · Mental Disorders
Bottom Line
View on ClinicalTrials.gov: NCT02196506 ↗Enrolled (actual)
837
Serious AEs
0.3%
Results posted
Aug 2018
Primary outcome: Primary: Change in the Montgomery-Asberg Depression — -10.4; -8.07 Units on a scale — p=0.0074
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo + ADT (Drug); Brexpiprazole +ADT (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Montgomery-Asberg Depression |
-10.4; -8.07 | 0.0074 sig |
| SECONDARY Change in the Sheehan Disability Scale (SDS) From Baseline to End of Treatment |
-1.63; -1.41 | 0.3331 |
| SECONDARY 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 |
-11.1; -8.87 | 0.0263 sig |
| SECONDARY 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). |
-11.8; -8.87 | 0.0099 sig |
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
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
Data sourced from ClinicalTrials.gov (NCT02196506). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.