Trials / Completed
CompletedNCT02196506
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
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 837 (actual)
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo + ADT | Placebo + ADT Placebo + FDA Approved Antidepressant (ADT) |
| DRUG | Brexpiprazole +ADT | Brexpiprazole + ADT Tablet, Oral, 2mg brexpiprazole and FDA Approved Antidepressant (ADT) |
Timeline
- Start date
- 2014-07-01
- Primary completion
- 2016-04-01
- Completion
- 2016-05-01
- First posted
- 2014-07-22
- Last updated
- 2018-08-21
- Results posted
- 2018-08-21
Locations
47 sites across 5 countries: United States, Germany, Hungary, Poland, Slovakia
Source: ClinicalTrials.gov record NCT02196506. Inclusion in this directory is not an endorsement.