NCT01715805

Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD)

A Phase 3, Double-Blind, Placebo-Controlled Study of Cariprazine as Adjunctive Therapy in Major Depressive Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,022 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Cariprazine	Cariprazine capsules 1.5 to 4.5 mg/day
DRUG	Placebo	Dose-matched placebo capsule once per day
DRUG	Antidepressant Therapy (ADT)	ADT such as bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, paroxetine or vilazodone as prescribed by the physician.

Timeline

• Start date: 2012-11-15
• Primary completion: 2016-06-24
• Completion: 2016-06-24
• First posted: 2012-10-29
• Last updated: 2019-08-28
• Results posted: 2019-08-28

Locations

85 sites across 2 countries: United States, Puerto Rico