NCT01469377

Safety and Efficacy of Cariprazine as an Adjunctive to Antidepressant Therapy in Major Depressive Disorder

A Double-Blind, Placebo-Controlled Study of Cariprazine (RGH-188) as Adjunctive Therapy in Major Depressive Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 819 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

An outpatient study to evaluate the safety and efficacy of cariprazine as adjunct to antidepressant therapy (ADT) in participants with major depressive disorder (MDD) who have an inadequate response to ADT alone. This clinical study compared cariprazine + ADT with placebo + ADT in outpatients with a diagnosis of MDD and an inadequate response to ADT. The study consisted of approximately 2 weeks of screening and washout followed by 8 weeks of double-blind treatment followed by a 1 week safety follow-up.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Placebo	Placebo was supplied in capsules
DRUG	Cariprazine	Cariprazine was supplied in capsules.

Timeline

• Start date: 2011-12-15
• Primary completion: 2013-12-12
• Completion: 2013-12-12
• First posted: 2011-11-10
• Last updated: 2018-05-01
• Results posted: 2018-05-01

Locations

72 sites across 6 countries: United States, Estonia, Finland, Slovakia, Sweden, Ukraine