Study of the Safety and Efficacy of Two Fixed Doses of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Polaris Trial)
Completed
Otsuka Pharmaceutical Development & Commercialization, Inc.
Phase 3
2011-06-01
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
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)
Completed
Otsuka Pharmaceutical Development & Commercialization, Inc.
Phase 3
2011-07-01
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
Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial)
Completed
Otsuka Pharmaceutical Development & Commercialization, Inc.
Phase 3
2011-10-01
To assess the long-term safety and tolerability of oral OPC-34712 (brexpiprazole), given in
addition to an FDA approved antidepressant (ADT) for the treatment of adults with Major
Depressive Disorder (MDD)
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