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Safety, Tolerability, and Efficacy of Cariprazine for Patients With Bipolar Depression

This study is currently recruiting participants.
Verified May 2013 by Forest Laboratories
Sponsor:
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01396447
First received: July 15, 2011
Last updated: May 31, 2013
Last verified: May 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Depression, Bipolar
 Drug: Placebo
Drug: Cariprazine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in Patients With Bipolar Depression

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Week 6 to Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impressions - Severity (CGI-S) [ Time Frame: Week 6 to Week 8 ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: July 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
 Drug: Placebo
Patients who meet eligibility criteria will be administered a once daily oral dose of placebo
Experimental: 2
Cariprazine, 0.75 mg/day
 Drug: Cariprazine
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine
Experimental: 3
Cariprazine, 1.5 mg/day
 Drug: Cariprazine
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine
Experimental: 4
Cariprazine, 3.0 mg/day
 Drug: Cariprazine
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine

  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 DSM-IV-TR (SCID) bipolar I depression without psychotic features
  • Patients with normal physical examination, laboratory, vital signs,and/ or ECG
  • Verified previous manic or mixed episode
  • Patients with a total Hamilton Rating Scale for Depression (HAMD)-17 score greater than or equal to 20
  • Patients with a HAMD-17 item 1 score greater than or equal to 2
  • Patients with a (Clinical Global Impression of Severity) CGI-S score of greater than or equal to 4

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01396447

Contacts
Contact: Sandra Beaird, PhD 1-800-678-1605 ext 66297 info@forestpharm.com

  Show 111 Study Locations
Sponsors and Collaborators
Forest Laboratories
Gedeon Richter Ltd.
Investigators
Study Director: Robert Dunn, MD, PhD Forest Laboratories
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01396447     History of Changes
Other Study ID Numbers: RGH-MD-56, 2011-002334-39
Study First Received: July 15, 2011
Last Updated: May 31, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Argentina: Ministry of Health
Bulgaria: Ministry of Health
Russia: Pharmacological Committee, Ministry of Health
Ukraine: Ministry of Health

Keywords provided by Forest Laboratories:
Bipolar I Disorder
Bipolar Depression
Depression
Bipolar Disorder

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
 Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on June 17, 2013