Trials / Completed
CompletedNCT03697603
A Study of Brexpiprazole in Patients With Major Depressive Disorder
A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group-comparison Trial to Assess the Efficacy and Safety of Brexpiprazole as Adjunctive Therapy in Patients With Major Depressive Disorder
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 740 (actual)
- Sponsor
- Otsuka Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years – 64 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this 14 week, randomized, double-blind, placebo controlled study is to assess the safety and efficacy of brexipiprazole to placebo as adjunctive treatment to an assigned open-label marketed antidepressant therapy (ADT) in patients with Major Depressive Disorder.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Brexpiprazole | Tablets, Oral, once daily, 14 weeks |
| DRUG | Placebo | Tablets, Oral, once daily, 14 weeks |
Timeline
- Start date
- 2018-07-30
- Primary completion
- 2022-06-06
- Completion
- 2022-07-04
- First posted
- 2018-10-05
- Last updated
- 2024-08-09
- Results posted
- 2024-08-09
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT03697603. Inclusion in this directory is not an endorsement.