NCT01360866

Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial)

A Long-term, Phase 3, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder, the Orion Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,944 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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)

Conditions

• Depressive Disorder
• Depression
• Depressive Disorder, Major
• Mood Disorders
• Mental Disorders

Interventions

Type	Name	Description
DRUG	OPC-34712	Tablet
DRUG	Escitalopram	Tablet
DRUG	Fluoxetine	Capsule
DRUG	Paroxetine CR	Controlled-release tablets
DRUG	Sertraline	Tablets
DRUG	Duloxetine	Delayed-release capsules
DRUG	Venlafaxine XR	Extended-release capsules

Timeline

• Start date: 2011-10-01
• Primary completion: 2017-04-18
• Completion: 2017-05-18
• First posted: 2011-05-26
• Last updated: 2018-09-17
• Results posted: 2018-09-17

Locations

142 sites across 11 countries: United States, Canada, France, Germany, Hungary, Poland, Romania, Russia, Serbia, Slovakia, Ukraine