Overview

This trial is active, not recruiting.

Condition major depressive disorder
Treatments cariprazine, placebo
Phase phase 3
Sponsor Forest Laboratories
Collaborator Gedeon Richter Ltd.
Start date November 2012
End date June 2016
Trial size 1100 participants
Trial identifier NCT01715805, RGH-MD-72

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Cariprazine, 1.5 milligrams to 4.5 milligrams per day, oral administration.
cariprazine
Patients who meet eligibility will have 1-2 week screening period followed by blind placebo, followed by 8 week double blind treatment period on cariprazine with Antidepressant Therapy (ADT) or placebo with ADT for inadequate responders and ADT with single blind placebo for responders, followed by a 1-week safety follow-up period
(Placebo Comparator)
Dose-matched placebo, onec per day, oral administration
placebo
Patients who meet eligibility will have 1-2 week screening period followed by blind placebo, followed by 8 week double blind treatment period on placebo with Antidepressant Therapy (ADT) for inadequate responders and ADT with single blind placebo for responders, followed by a 1-week safety follow-up period

Primary Outcomes

Measure
Montgomery-Asberg Depression Rating Scale
time frame: 8 weeks

Secondary Outcomes

Measure
Sheehan Disability Scale
time frame: 8 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Patients who have provided consent prior to any specific procedure - Meet the The Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR) criteria for Major Depressive Disorder (MDD) - Have a minimum score of 20 on 17-Item Hamilton Depression (HAMD-17) rating scale at Visits 1 and 2 Exclusion Criteria: - Patients who do not meet DSM-IV-TR criteria for MDD

Additional Information

Official title A Phase 3, Double-Blind, Placebo-Controlled Study of Cariprazine as Adjunctive Therapy in Major Depressive Disorder (MDD)
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Forest Laboratories.