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Safety and Efficacy of Cariprazine for Mania

This study has been completed.
Sponsor:
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01058096
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
Bipolar Disorder
Mania
Drug: Cariprazine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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 5-point scale (0-4) and 4-items on a 9-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 was a mixed model for repeated measurements (MMRM) observed cases (OC), 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 was based on a MMRM using the observed cases (OC) 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: 323
Study Start Date: February 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cariprazine
Cariprazine 3 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.
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.

  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: NCT01058096

Locations
United States, California
Forest Investigative Site 004
Long Beach, California, United States, 90813
Forest Investigative Site 005
Riverside, California, United States, 92506
Forest Investigative Site 007
San Diego, California, United States, 92123
United States, Illinois
Forest Investigative Site 009
Chicago, Illinois, United States, 60640
United States, Louisiana
Forest Investigative Site 006
Lake Charles, Louisiana, United States, 70601
United States, Mississippi
Forest Investigative Site 001
Flowood, Mississippi, United States, 39232
United States, Missouri
Forest Investigative Site 003
Creve Couer, Missouri, United States, 63141
United States, Ohio
Forest Investigative Site 008
Cleveland, Ohio, United States, 44109
United States, Oklahoma
Forest Investigative Site 010
Oklahoma City, Oklahoma, United States, 73116
United States, Texas
Forest Investigative Site 002
Houston, Texas, United States, 77008
India
Forest Investigative Site 106
Vijayawada, Andhra Pradesh, India, 520002
Forest Investigative Site 112
Vizag, Andhra Pradesh, India, 530017
Forest Investigator Site 108
Varanasi, Durgakund, India, 221005
Forest Investigative Site 103
Ahmedabad, Gujarat, India, 380013
Forest Investigative Site 120
Ahmedabad, Gujarat, India, 380015
Forest Investigative Site 105
Bangalore, Karnataka, India, 560010
Forest Investigative Site 107
Bangalore, Karnataka, India, 560027
Forest Investigative Site 118
Mangalore, Karnataka, India, 575001
Forest Investigative Site 113
Mangalore, Karnataka, India, 575018
Forest Investigative Site 115
Manipal, Karnataka, India, 576104
Forest Investigative Site 114
Mysore, Karnataka, India, 570004
Forest Investigative Site 101
Aurangabad, Maharashtra, India, 431005
Forest Investigative Site 110
Nasik, Maharashtra, India, 422101
Forest Investigative Site 111
Pune, Maharashtra, India, 411004
Forest Investigative Site 104
Pune, Maharashtra, India, 411030
Forest Investigative Site 121
Chennai, Tamilnadu, India, 600003
Forest Investigative Site 109
Kanpur, Uttar Pradesh, India, 200005
Forest Investigative Site 119
Lucknow, Uttar Pradesh, India, 226006
Sponsors and Collaborators
Forest Laboratories
Gedeon Richter Ltd.
Investigators
Study Director: Elizabeth Diaz, MD Forest Laboratories
  More Information

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01058096     History of Changes
Other Study ID Numbers: RGH-MD-32
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:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 24, 2017