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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: March 1, 2017
Last verified: March 2017
  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 Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3 [ Time Frame: Baseline, Week 3 ]
    The YMRS is an 11-item scale that assesses manic symptoms based on the participant's perception of his or her condition over the previous 48 hours, as well as the physician's clinical observations during the interview. The 11-items are elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, rate and amount of speech, language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. The severity of the abnormality for 7-items are rated on a five-point scale (0-4) and 4-items on a nine-point scale (0-8). The individual scores are summed for a total possible score of 0 (best) to 60 (worst). A negative change from Baseline indicates improvement. Analysis is a mixed model for repeated measurements (MMRM) using observed cases, with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix.


Secondary Outcome Measures:
  • Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3 [ Time Frame: Baseline, Week 3 ]
    The CGI-S measures the investigator's assessment of overall severity of the participant's illness compared with the severity of illness in other patients the physician has observed using a 7-point scale (1=Normal, not ill at all to 7= Among the most extremely ill participants). A negative change from Baseline indicates improvement. Analysis is based on a MMRM using the observed cases data, with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix.


Enrollment: 497
Study Start Date: February 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cariprazine (3-6 mg/day)
Cariprazine 3 milligrams (mg) - 6 mg capsules oral administration, once per day for 3 weeks.
Drug: Cariprazine
Patients who meet eligibility criteria will be administered a once daily oral 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: Cariprazine (6-12 mg/day)
Cariprazine 6 mg - 12 mg capsules oral administration, once per day for 3 weeks.
Drug: Cariprazine
Patients who meet eligibility criteria will be administered a once daily oral 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: Placebo
Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
Drug: Placebo
Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for three weeks.

  Eligibility

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 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01058668     History of Changes
Other Study ID Numbers: RGH-MD-33
Study First Received: January 27, 2010
Results First Received: March 1, 2017
Last Updated: March 1, 2017

Keywords provided by Forest Laboratories:
Acute Mania
Bipolar I Disorder

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 19, 2017