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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01396447
Recruitment Status : Completed
First Posted : July 18, 2011
Last Update Posted : March 18, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The objective of this study was to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of patients with bipolar depression.

Condition or disease Intervention/treatment Phase
Depression, Bipolar Drug: Placebo Drug: Cariprazine Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 584 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : July 2011
Primary Completion Date : January 2014
Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Cariprazine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Placebo
Patients who meet eligibility criteria will be administered a once daily oral dose of placebo
Drug: Placebo
Placebo was supplied in capsules.
Experimental: Cariprazine 0.75 mg
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine
Drug: Cariprazine
Cariprazine was supplied in capsules.
Experimental: Cariprazine 1.5 mg
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine
Drug: Cariprazine
Cariprazine was supplied in capsules.
Experimental: Cariprazine 3.0 mg
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine
Drug: Cariprazine
Cariprazine was supplied in capsules.


Outcome Measures

Primary Outcome Measures :
  1. Change from Baseline in the Montgomery-Åsberg Depression Rating Scale total score at Week 6 [ Time Frame: Week 6 to Week 8 ]

Secondary Outcome Measures :
  1. Change from Baseline in the Clinical Global Impressions-Severity total score at Week 6 [ Time Frame: Week 6 to Week 8 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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 (SCID) for DSM-IV-TR bipolar I depression without psychotic features.
  • Patients with normal physical examination, laboratory, vital signs,and/ or echocardiogram (ECG).
  • Verified previous manic or mixed episode.
  • Patients with a total Hamilton Rating Scale for Depression (HAMD)-17 score ≥ 20.
  • Patients with a HAMD-17 item 1 score ≥ 2.
  • Patients with a Clinical Global Impression of Severity (CGI-S) score ≥ 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 6 months.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01396447


  Show 88 Study Locations
Sponsors and Collaborators
Forest Laboratories
Gedeon Richter Ltd.
Investigators
Study Director: Alan Lipschitz, MD Forest Laboratories
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01396447     History of Changes
Other Study ID Numbers: RGH-MD-56
2011-002334-39 ( EudraCT Number )
First Posted: July 18, 2011    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: February 2015

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders