Safety and Efficacy of Cariprazine as an Adjunctive to Antidepressant Therapy in Major Depressive Disorder

This study is currently recruiting participants.

Verified April 2013 by Forest Laboratories

Sponsor:

Collaborator:

Gedeon Richter Ltd.

Information provided by (Responsible Party):

Forest Laboratories

ClinicalTrials.gov Identifier:

NCT01469377

First received: November 8, 2011

Last updated: April 15, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

November 8, 2011

Last Updated Date

April 15, 2013

Start Date ^ICMJE

December 2011

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01469377 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Sheehan Disability Scale (SDS) [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy of Cariprazine as an Adjunctive to Antidepressant Therapy in Major Depressive Disorder

Official Title ^ICMJE

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

Brief Summary

An outpatient study to evaluate the safety and efficacy of cariprazine as adjunct to Antidepressant Therapy (ADT) in patients with Major Depressive Disorder (MDD) who have an inadequate response to antidepressant alone. This clinical study will be comparing cariprazine + ADT with placebo + ADT in outpatients with a diagnosis of MDD and an inadequate response to ADT in the current episode. The study will consist of approximately 2 weeks of screening and washout followed by 8 weeks of double-blind treatment followed by a 1 week safety follow-up.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Major Depressive Disorder

Intervention ^ICMJE

Drug: cariprazine
cariprazine (2-4.5 mg/day) given orally, in capsule form, once daily for 8 weeks
Drug: cariprazine
cariprazine (1-2 mg/day) given orally, in capsule form, once daily for 8 weeks
Drug: placebo
Matched placebo given orally, in capsule form, once daily for 8 weeks

Study Arm (s)

Experimental: cariprazine 2-4.5 mg
Intervention: Drug: cariprazine
Experimental: cariprazine 1-2 mg/day
Intervention: Drug: cariprazine
Placebo Comparator: Placebo
Intervention: Drug: placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

810

Estimated Completion Date

September 2014

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male or female outpatients 18 to 65 years of age, inclusive
Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for moderate to severe MDD
Current major depressive episode of at least 8 weeks and not exceeding 24 months in duration
Ongoing inadequate response to protocol allowed ADT

Exclusion Criteria:

Principal DSM-IV-TR-based diagnosis of an axis I disorder, other than MDD,
Women who are pregnant, or planning to become pregnant or breastfeed during the study or not practicing reliable contraception that will continue through out the study
History of meeting DSM-IV-TR criteria for:
1. Depressive episode with psychotic or catatonic features
2. Manic, hypomanic or mixed episode, including bipolar disorder and substance induced manic, hypomanic or mixed episode
3. Schizophrenia, schizoaffective, or other psychotic disorder
4. Obsessive-compulsive disorder
5. Bulimia or anorexia nervosa
6. Dementia, amnesic, or other cognitive disorder
7. Mental retardation
Patients considered a suicide risk

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Sandra Beaird, Pharm.D

1-800-678-1605 ext 66297

FRXClinTrials@frx.com

Location Countries ^ICMJE

United States, Estonia, Finland, Lithuania, Slovakia, Sweden, Ukraine

Administrative Information

NCT Number ^ICMJE

NCT01469377

Other Study ID Numbers ^ICMJE

RGH-MD-75

Has Data Monitoring Committee

Responsible Party

Forest Laboratories

Study Sponsor ^ICMJE

Forest Laboratories

Collaborators ^ICMJE

Gedeon Richter Ltd.

Investigators ^ICMJE

Study Director:

Vinu George, MD

Forest Laboratories

Information Provided By

Forest Laboratories

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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