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NCT01058668 Clinical Trial

Safety and Efficacy of Cariprazine for Bipolar I Disorder

Bipolar I Disorder Clinical Trial

Official title:
A Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of Cariprazine in Patients With Acute Mania Associated With Bipolar I Disorder

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01058668
Other study ID # RGH-MD-33
Secondary ID
Status Completed
Phase Phase 3
First received January 27, 2010
Last updated December 30, 2011
Start date January 2010

Study information
Verified date December 2011
Source Forest Laboratories
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationCroatia: Agency for Medicinal Product and Medical DevicesUkraine: State Pharmacological Center - Ministry of HealthRussia: Ministry of Health of the Russian FederationSerbia and Montenegro: Agency for Drugs and Medicinal DevicesRomania: National Medicines Agency
Study type Interventional

Clinical Trial Summary

The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder.

Recruitment information / eligibility
Status Completed
Enrollment 507
Est. completion date
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Patients who have provided informed consent prior to any study specific procedures

- Patients 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 for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID) manic or mixed type with or without psychotic symptoms

- Voluntarily hospitalized for current manic episode

- Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)

Exclusion Criteria:

- Patients 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 six months

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Cariprazine low dose
Patients who meet eligibility criteria will be administered a once daily oral low dose of cariprazine for three weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
• Cariprazine high dose
Patients who meet eligibility criteria will be administered a once daily oral high dose of cariprazine for three weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
• Placebo
Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for three weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.

Locations
Country Name City State
Croatia Forest Investigative Site 607 Rijeka
Croatia Forest Investigative Site 602 Zagreb
Croatia Forest Investigative Site 605 Zagreb
Croatia Forest Investigative Site 606 Zagreb
Romania Forest Investigative Site 209 Arad
Romania Forest Investigative Site 203 Bucharest
Romania Forest Investigative Site 205 Bucuresti
Romania Forest Investigative Site 206 Bucuresti
Romania Forest Investigative Site 208 Bucuresti
Romania Forest Investigative Site 202 Constanta
Romania Forest Investigative Site 201 Craiova
Romania Forest Investigative Site 210 Craiova Dolj
Romania Forest Investigative Site 212 Focsani Vrancea
Romania Forest Investigative Site 204 Targoviste Dambovita
Romania Forest Investigative Site 211 Timisoara Timis
Russian Federation Forest Investigative Site 501 Lipetsk
Russian Federation Forest Investigative Site 503 Moscow
Russian Federation Forest Investigative Site 507 Moscow
Russian Federation Forest Investigative Site 510 Moscow
Russian Federation Forest Investigative Site 506 Saint Petersburg
Russian Federation Forest Investigative Site 508 Saint Petersburg
Russian Federation Forest Investigative Site 509 Samara
Russian Federation Forest Investigative Site 504 Saratov
Russian Federation Forest Investigative Site 502 Smolensk
Serbia Forest Investigative Site 403 Belgrade
Serbia Forest Investigative Site 404 Belgrade
Serbia Forest Investigative Site 405 Belgrade
Serbia Forest Investigative Site 402 Kragujevac
Serbia Forest Investigative Site 401 Senta
Ukraine Forest Investigative Site 308 Dnipropetrovsk
Ukraine Forest Investigative Site 315 Dnipropetrovsk
Ukraine Forest Investigative Site 301 Donetsk
Ukraine Forest Investigative Site 307 Kharkiv
Ukraine Forest Investigative Site 310 Kharkiv
Ukraine Forest Investigative Site 303 Kyiv
Ukraine Forest Investigative Site 304 Kyiv
Ukraine Forest Investigative Site 305 Kyiv
Ukraine Forest Investigative Site 309 Kyiv
Ukraine Forest Investigative Site 312 Kyiv
Ukraine Forest Investigative Site 306 Lugansk
Ukraine Forest Investigative Site 311 Lviv
Ukraine Forest Investigative Site 302 Odessa
Ukraine Forest Investigative Site 314 Poltava
United States Forest Investigative Site 026 Atlanta Georgia
United States Forest Investigative Site 014 Bothell Washington
United States Forest Investigative Site 008 Cedarhurst New York
United States Forest Investigative Site 012 Cerritos California
United States Forest Investigative Site 010 Costa Mesa California
United States Forest Investigative Site 021 Greenwood Indiana
United States Forest Investigative Site 011 Hoffman Estates Illinois
United States Forest Investigative Site 013 Honolulu Hawaii
United States Forest Investigative Site 004 Irving Texas
United States Forest Investigative Site 002 Kissimmee Florida
United States Forest Investigative Site 018 Little Rock Arkansas
United States Forest Investigative Site 015 Memphis Tennessee
United States Forest Investigative Site 016 New Britain Connecticut
United States Forest Investigative Site 005 Oceanside California
United States Forest Investigative Site 003 Orlando Florida
United States Forest Investigative Site 019 Philadelphia Pennsylvania
United States Forest Investigative Site 006 Rockville Maryland
United States Forest Investigative Site 017 San Diego California
United States Forest Investigative Site 023 San Diego California
United States Forest Investigative Site 024 Santa Ana California
United States Forest Investigative Site 001 Shreveport Louisiana
United States Forest Investigative Site 025 St. Louis Missouri
United States Forest Investigative Site 007 Washington District of Columbia

Sponsors (2)
Lead Sponsor Collaborator
Forest Laboratories Gedeon Richter Ltd.

Countries where clinical trial is conducted

United States,  Croatia,  Romania,  Russian Federation,  Serbia,  Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Primary Young Mania Rating Scale (YMRS) 3 Weeks No
Secondary Clinical Global Impression - Severity (CGI-S) 3 Weeks No
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