CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 231 enrolled
Drug / intervention
Antidepressant + placebo +2 moredrug
Likely dose
Antidepressant + cariprazine (0.1-0.3 mg/day)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00854100
NCT00854100Phase 2Completed
CompareCT.gov

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

Forest Laboratories·interventional·Posted Mar 2, 2009·Updated Mar 5, 2019

In Brief

A Phase 2 clinical trial evaluating Antidepressant + placebo, Antidepressant + cariprazine (0.1-0.3 mg/day), and 1 other intervention for Major Depressive Disorder. Completed, enrolled 231 participants across 41 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesUnited States
CollaboratorsGedeon Richter Ltd.

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2, 2009
Enrollment StartJun 30, 2009
Primary CompletionDec 6, 2010
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 17.3 years ago

Interventions

Antidepressant + placebodrug

Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.

Antidepressant + cariprazine (0.1-0.3 mg/day)drug

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.

Antidepressant + cariprazine (1-2 mg/d)drug

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.