Trials / Completed
CompletedNCT01360645
Study of the Safety and Efficacy of Fixed Dose OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Pyxis Trial)
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Fixed Dose OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Pyxis Trial
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 826 (actual)
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
To compare the effect of OPC-34712 (brexpiprazole) to the effect of placebo (an inactive substance) as add on treatment to an assigned FDA approved antidepressant treatment (ADT) in patients with Major Depressive Disorder who demonstrate an incomplete response to a prospective trial of the same assigned FDA approved ADT
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OPC-34712 + ADT | Tablet, Oral, 2 mg OPC-34712 and FDA Approved Antidepressant Therapy (ADT) |
| DRUG | Placebo + ADT | Placebo + FDA Approved Antidepressant (ADT) |
| DRUG | Placebo + ADT | Placebo + FDA Approved Antidepressant (ADT) |
Timeline
- Start date
- 2011-07-01
- Primary completion
- 2013-05-01
- Completion
- 2013-06-01
- First posted
- 2011-05-25
- Last updated
- 2015-11-26
- Results posted
- 2015-11-26
Locations
57 sites across 5 countries: United States, Canada, France, Poland, Slovakia
Source: ClinicalTrials.gov record NCT01360645. Inclusion in this directory is not an endorsement.