NCT00854100

Safety and Efficacy of Cariprazine As Adjunctive 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: 231 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is an outpatient study to evaluate the safety, and efficacy of RGH-188 as an add-on therapy to standard antidepressants in patients who did not respond to previous antidepressant therapy.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Antidepressant + placebo	Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.
DRUG	Antidepressant + cariprazine (0.1-0.3 mg/day)	Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine (0.1-0.3 mg/d) Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.
DRUG	Antidepressant + cariprazine (1-2 mg/d)	Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine (1-2 mg/d) Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.

Timeline

• Start date: 2009-06-30
• Primary completion: 2010-12-06
• Completion: 2010-12-06
• First posted: 2009-03-02
• Last updated: 2019-03-05
• Results posted: 2019-03-05

Locations

41 sites across 1 country: United States