Phase 3
Completed 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
Source: ClinicalTrials.gov NCT02196506 ↗Enrolled (actual)
837
Serious AEs
0.3%
Results posted
Aug 2018
Primary outcomePrimary: Change in the Montgomery-Asberg Depression — -10.4; -8.07 Units on a scale — p=0.0074
◆ Published Evidence
Emerging
7citations · ~4 / year
Effects of Adjunctive Brexpiprazole on Individual Depressive Symptoms and Functioning in Patients With Major Depressive Disorder and Anxious Distress: Post Hoc Analysis of Three Placebo-Controlled Studies.
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
Linked Publications (5)
-
Effects of Adjunctive Brexpiprazole on Individual Depressive Symptoms and Functioning in Patients With Major Depressive Disorder and Anxious Distress: Post Hoc Analysis of Three Placebo-Controlled Studies.
-
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.
-
Effects of adjunctive brexpiprazole in patients with major depressive disorder and sleep disturbance: a <i>post hoc</i> analysis of three randomized trials.
-
Adjunctive brexpiprazole in patients with major depressive disorder who show minimal or partial response to antidepressant treatment: post hoc analysis of randomized controlled trials.
-
Adjunctive brexpiprazole in patients with unresolved symptoms of depression on antidepressant treatment who are early in the disease course: post hoc analysis of randomized controlled trials.
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 |
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) and the linked publication. 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. Informational only — not medical advice.