Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression

Depression, Bipolar Clinical Trial

Official title:

A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in Patients With Bipolar Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01396447
• Other study ID #: RGH-MD-56
• Secondary ID: 2011-002334-39
• Status: Completed
• Phase: Phase 2
• Start date: July 26, 2011
• Est. completion date: January 10, 2014

Study information

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

Clinical Trial Summary

The objective of this study was to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of participants with bipolar depression.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 584
• Est. completion date: January 10, 2014
• Est. primary completion date: January 10, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Participants who have provided informed consent prior to any study specific procedures.

• Participants currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder as confirmed by the Structured Clinical Interview (SCID) with a current with a current major depressive episode of at least 4 weeks and not exceeding 12 months in duration.

• Participants with normal physical examination, laboratory, vital signs, and/or echocardiogram (ECG).

• Verified previous manic or mixed episode.

• Participants with a total Hamilton Rating Scale for Depression (HAMD)-17 score = 20.

• Participants with a HAMD-17 item 1 score = 2.

• Participants with a Clinical Global Impression of Severity (CGI-S) score = 4.

Exclusion Criteria:

• Participants with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous 6 months.

• Women who are pregnant or breast feeding

• Participants with Young Mania Rating Scale (YMRS) total score > 10

• Participants who have dementia, mental retardation, schizophrenia/schizoaffective disorder.

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depression, Bipolar
• Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
Bulgaria	Forest Investigative Site 311	Kardzhali
Bulgaria	Forest Investigative Site 307	Kazanlak
Bulgaria	Forest Investigative Site 310	Lovech
Bulgaria	Forest Investigative Site 313	Novi Iskar
Bulgaria	Forest Investigative Site 309	Pazardzhik
Bulgaria	Forest Investigative Site 302	Pleven
Bulgaria	Forest Investigative Site 301	Plovdiv
Bulgaria	Forest Investigative Site 305	Sofia
Bulgaria	Forest Investigative Site 306	Sofia
Bulgaria	Forest Investigative Site 308	Tsarev Brod
Bulgaria	Forest Investigative Site 312	Tserova Koria
Canada	Forest Investigative Site 101	Chatham	Ontario
Canada	Forest Investigative Site 102	Kelowna	British Columbia
Canada	Forest Investigative Site 103	Penticton	British Columbia
Colombia	Forest Investigative Site 804	Barranquilla
Colombia	Forest Investigative Site 806	Barranquilla
Colombia	Forest Investigative Site 803	Bogota
Colombia	Forest Investigative Site 805	Bogotá
Colombia	Forest Investigative Site 808	Bogotá
Colombia	Forest Investigative Site 807	Pereira
Russian Federation	Forest Investigative Site 601	Arkhangelsk
Russian Federation	Forest Investigative Site 605	Moscow
Russian Federation	Forest Investigative Site 607	Moscow
Russian Federation	Forest Investigative Site 611	Moscow
Russian Federation	Forest Investigative Site 619	Moscow
Russian Federation	Forest Investigative Site 603	Nizhniy Novgorod
Russian Federation	Forest Investigative Site 612	Saint-Petersburg
Russian Federation	Forest Investigative Site 617	Samara
Russian Federation	Forest Investigative Site 616	Saratov
Russian Federation	Forest Investigative Site 602	St. Petersburg
Russian Federation	Forest Investigative Site 604	St. Petersburg
Russian Federation	Forest Investigative Site 606	St. Petersburg
Russian Federation	Forest Investigative Site 608	St. Petersburg
Russian Federation	Forest Investigative Site 613	St. Petersburg
Russian Federation	Forest Investigative Site 615	St. Petersburg
Russian Federation	Forest Investigative Site 609	Tomsk
Russian Federation	Forest Investigative Site 618	Tver
Russian Federation	Forest Investigative Site 610	Voronezh
Ukraine	Forest Investigative Site 714	Donetsk
Ukraine	Forest Investigative Site 712	Ivano-Frankivsk
Ukraine	Forest Investigative Site 707	Kerch	AR Crimea
Ukraine	Forest Investigative Site 702	Kharkiv
Ukraine	Forest Investigative Site 703	Kharkiv
Ukraine	Forest Investigative Site 704	Kharkiv
Ukraine	Forest Investigative Site 709	Kherson	Vil. Stepanivka
Ukraine	Forest Investigative Site 701	Kyiv
Ukraine	Forest Investigative Site 708	Kyiv
Ukraine	Forest Investigative Site 710	Odesa
Ukraine	Forest Investigative Site 706	Simferopol
Ukraine	Forest Investigative Site 705	Vinnytsia
United States	Forest Investigative Site 006	Albuquerque	New Mexico
United States	Forest Investigative Site 009	Allentown	Pennsylvania
United States	Forest Investigative Site 005	Atlanta	Georgia
United States	Forest Investigative Site 038	Atlanta	Georgia
United States	Forest Investigative Site 043	Bellevue	Washington
United States	Forest Investigative Site 030	Beverly Hills	California
United States	Forest Investigative Site 021	Birmingham	Alabama
United States	Forest Investigative Site 003	Brooklyn	New York
United States	Forest Investigative Site 036	Canton	Ohio
United States	Forest Investigative Site 018	Cerritos	California
United States	Forest Investigative Site 023	Cherry Hill	New Jersey
United States	Forest Investigative Site 029	Chicago	Illinois
United States	Forest Investigative Site 028	Costa Mesa	California
United States	Forest Investigative Site 026	Creve Coeur	Missouri
United States	Forest Investigative Site 007	Dallas	Texas
United States	Forest Investigative Site 008	Dayton	Ohio
United States	Forest Investigative Site 039	Flowood	Mississippi
United States	Forest Investigative Site 016	Houston	Texas
United States	Forest Investigative Site 027	Houston	Texas
United States	Forest Investigative Site 024	Indianapolis	Indiana
United States	Forest Investigative Site 012	Jacksonville	Florida
United States	Forest Investigative Site 041	Lake Charles	Louisiana
United States	Forest Investigative Site 037	Las Vegas	Nevada
United States	Forest Investigative Site 033	Lincoln	Rhode Island
United States	Forest Investigative Site 014	Marlton	New Jersey
United States	Forest Investigative Site 010	Media	Pennsylvania
United States	Forest Investigative Site 019	Memphis	Tennessee
United States	Forest Investigative Site 025	New York	New York
United States	Forest Investigative Site 015	Oceanside	California
United States	Forest Investigative Site 035	Orlando	Florida
United States	Forest Investigative Site 031	Prairie Village	Kansas
United States	Forest Investigative Site 042	Salem	Oregon
United States	Forest Investigative Site 020	San Antonio	Texas
United States	Forest Investigative Site 032	Seattle	Washington
United States	Forest Investigative Site 040	Shreveport	Louisiana
United States	Forest Investigative Site 017	Springdale	Arkansas
United States	Forest Investigative Site 011	Temecula	California
United States	Forest Investigative Site 013	Winter Park	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Forest Laboratories	Gedeon Richter Ltd.

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Colombia,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in the Montgomery-Åsberg Depression Rating Scale Total Score at Week 6	The Montgomery-Åsberg Depression Rating Scale is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants are rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. The scores on the 10 items are summed for a total score that can range from 0 to 60. A higher score indicates greater depression. A negative change score indicates improvement.	Baseline to Week 6
Secondary	Change From Baseline in the Clinical Global Impressions-Severity Total Score at Week 6	The Clinical Global Impressions-Severity scale is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of illness in other participants the physician has observed. The participant is rated on a scale from 1 to 7 with 1 indicating a "normal state" and 7 indicating "among the most extremely ill participants." A higher score indicates greater illness. A negative change score indicates improvement.	Baseline to Week 6