Safety and Efficacy of Cariprazine for Bipolar I Disorder

This study has been completed.
Sponsor:
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01058668
First received: January 27, 2010
Last updated: December 30, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Mania
Bipolar I Disorder
Drug: Cariprazine low dose
Drug: Cariprazine high dose
Drug: Placebo
Phase 3

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

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Young Mania Rating Scale (YMRS) [ Time Frame: 3 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impression - Severity (CGI-S) [ Time Frame: 3 Weeks ] [ Designated as safety issue: No ]

Enrollment: 507
Study Start Date: January 2010
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Cariprazine low dose
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.
Experimental: 2
Cariprazine high dose
Drug: 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 Comparator: 3
Placebo
Drug: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01058668

  Show 66 Study Locations
Sponsors and Collaborators
Forest Laboratories
Gedeon Richter Ltd.
Investigators
Study Director: Elizabeth Diaz, MD Forest Laboratories
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01058668     History of Changes
Other Study ID Numbers: RGH-MD-33
Study First Received: January 27, 2010
Last Updated: December 30, 2011
Health Authority: United States: Food and Drug Administration
Croatia: Agency for Medicinal Product and Medical Devices
Ukraine: State Pharmacological Center - Ministry of Health
Russia: Ministry of Health of the Russian Federation
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Romania: National Medicines Agency

Keywords provided by Forest Laboratories:
Acute Mania
Bipolar I Disorder

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 26, 2014