CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 819 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Not stated in 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/NCT01469377
NCT01469377Phase 2Completed

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

Forest Laboratories·interventional·Posted Nov 10, 2011·Updated May 1, 2018

In Brief

A Phase 2 clinical trial evaluating Placebo and Cariprazine for Major Depressive Disorder. Completed, enrolled 819 participants across 72 sites in 6 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEstonia, Finland, Slovakia, Sweden, Ukraine, United States
CollaboratorsGedeon Richter Ltd.

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 10, 2011
Enrollment StartDec 15, 2011
Primary CompletionDec 12, 2013
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 14.6 years ago

Interventions

Placebodrug

Placebo was supplied in capsules

Cariprazinedrug

Cariprazine was supplied in capsules.