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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01469377
• Other study ID #: RGH-MD-75
• Status: Completed
• Phase: Phase 2
• Start date: December 15, 2011
• Est. completion date: December 12, 2013

Study information

• Verified date: March 2018
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 819
• Est. completion date: December 12, 2013
• Est. primary completion date: December 12, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 major depressive disorder (MDD).

• Current major depressive episode of at least 8 weeks and not exceeding 24 months in duration.

• Ongoing inadequate response to protocol allowed antidepressant therapy (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.

• Participants considered a suicide risk.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• Placebo
Placebo was supplied in capsules
• Cariprazine
Cariprazine was supplied in capsules.

Locations

Country	Name	City	State
Estonia	Forest Investigative Site 201	Tallinn
Estonia	Forest Investigative Site 203	Tallinn
Estonia	Forest Investigative Site 205	Tallinn
Estonia	Forest Investigative Site 206	Tallinn
Estonia	Forest Investigative Site 204	Tartu
Estonia	Forest Investigative Site 207	Tartu
Estonia	Forest Investigative Site 208	Tartu
Estonia	Forest Investigative Site 202	Võru
Finland	Forest Investigative Site 301	Helsinki
Finland	Forest Investigative Site 302	Helsinki
Finland	Forest Investigative Site 303	Helsinki
Finland	Forest Investigative Site 304	Helsinki
Finland	Forest Investigative Site 305	Kuopio
Finland	Forest Investigative Site 308	Oulu
Finland	Forest Investigative Site 307	Pori
Slovakia	Forest Investigative Site 602	Banska Stiavnica
Slovakia	Forest Investigative Site 603	Bardejov
Slovakia	Forest Investigative Site 604	Bratislava
Slovakia	Forest Investigative Site 606	Bratislava
Slovakia	Forest Investigative Site 601	Michalovce
Slovakia	Forest Investigative Site 605	Rimavska Sobota
Slovakia	Forest Investigative Site 607	Rimavska Sobota
Sweden	Forest Investigative Site 803	Lund
Sweden	Forest Investigative Site 802	Malmö
Sweden	Forest Investigative Site 801	Stockholm
Ukraine	Forest Investigative Site 703	Kharkiv
Ukraine	Forest Investigative Site 704	Kharkiv
Ukraine	Forest Investigative Site 701	Kyiv
Ukraine	Forest Investigative Site 702	Kyiv
Ukraine	Forest Investigative Site 710	Lugansk
Ukraine	Forest Investigative Site 709	Odesa
Ukraine	Forest Investigative Site 705	Stepanivka	Kherson
Ukraine	Forest Investigative Site 706	Vinnytsia
United States	Forest Investigative Site 030	Albuquerque	New Mexico
United States	Forest Investigative Site 062	Atlanta	Georgia
United States	Forest Investigative Site 024	Austin	Texas
United States	Forest Investigative Site 032	Bellevue	Washington
United States	Forest Investigative Site 069	Bridgeville	Pennsylvania
United States	Forest Investigative Site 076	Brooklyn	New York
United States	Forest Investigative Site 047	Canton	Ohio
United States	Forest Investigative Site 061	Cherry Hill	New Jersey
United States	Forest Investigative Site 068	Creve Coeur	Missouri
United States	Forest Investigative Site 020	Dallas	Texas
United States	Forest Investigative Site 021	Dayton	Ohio
United States	Forest Investigative Site 040	Flowood	Mississippi
United States	Forest Investigative Site 063	Gainesville	Florida
United States	Forest Investigative Site 077	Garden Grove	California
United States	Forest Investigative Site 070	Houston	Texas
United States	Forest Investigative Site 029	Jacksonville	Florida
United States	Forest Investigative Site 034	Kirkland	Washington
United States	Forest Investigative Site 012	Kissimmee	Florida
United States	Forest Investigative Site 038	Marlton	New Jersey
United States	Forest Investigative Site 048	Memphis	Tennessee
United States	Forest Investigative Site 023	Miami	Florida
United States	Forest Investigative Site 037	Mount Kisco	New York
United States	Forest Investigative Site 019	National City	California
United States	Forest Investigative Site 049	New York	New York
United States	Forest Investigative Site 067	New York	New York
United States	Forest Investigative Site 039	Oceanside	California
United States	Forest Investigative Site 015	Orange	California
United States	Forest Investigative Site 050	Orange	California
United States	Forest Investigative Site 026	Orlando	Florida
United States	Forest Investigative Site 025	Philadelphia	Pennsylvania
United States	Forest Investigative Site 022	Portland	Oregon
United States	Forest Investigative Site 074	Prairie Village	Kansas
United States	Forest Investigative Site 031	Reading	Pennsylvania
United States	Forest Investigative Site 008	Redlands	California
United States	Forest Investigative Site 027	Salem	Oregon
United States	Forest Investigative Site 028	Salt Lake City	Utah
United States	Forest Investigative Site 080	San Antonio	Texas
United States	Forest Investigative Site 066	Sherman Oaks	California
United States	Forest Investigative Site 065	Smyrna	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Forest Laboratories	Gedeon Richter Ltd.

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 8	The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.	Baseline to Week 8
Secondary	Change From Baseline in the Sheehan Disability Scale (SDS) Total Score at Week 8	The SDS measures an individual's perception of the extent to which his or her emotional symptoms are disrupting his or her functioning in 3 domains, work/school, social life/leisure activities, and family life/home responsibilities. The participant is asked to rate the degree to which their functioning is impaired on an 11-point scale, ranging from 0 (not at all) to 10 (extremely). Scores of 0 to 3 indicate mild functional impairment, 4 to 6 indicate moderate functional impairment, and 7 to 9 indicate marked functional impairment. The scores for the 3 domains are summed into a total score that ranges from 0 (unimpaired) to 30 (highly impaired). A higher score indicates greater impairment. A negative change score indicates improvement.	Baseline to Week 8