MedPath

Safety and Efficacy of Cariprazine for Mania

Phase 3
Completed
Conditions
Bipolar Disorder
Mania
Interventions
Drug: Placebo
Drug: Cariprazine
Registration Number
NCT01058096
Lead Sponsor
Forest Laboratories
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
323
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)
Read More
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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlaceboPlacebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
CariprazineCariprazineCariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
Primary Outcome Measures
NameTimeMethod
Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3Baseline, 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
NameTimeMethod
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3Baseline, 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.

Trial Locations

Locations (28)

Forest Investigative Site 112

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Vizag, Andhra Pradesh, India

Forest Investigator Site 108

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Varanasi, Durgakund, India

Forest Investigative Site 106

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Vijayawada, Andhra Pradesh, India

Forest Investigative Site 107

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Bangalore, Karnataka, India

Forest Investigative Site 115

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Manipal, Karnataka, India

Forest Investigative Site 114

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Mysore, Karnataka, India

Forest Investigative Site 121

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Chennai, Tamilnadu, India

Forest Investigative Site 009

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Chicago, Illinois, United States

Forest Investigative Site 006

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Lake Charles, Louisiana, United States

Forest Investigative Site 008

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Cleveland, Ohio, United States

Forest Investigative Site 118

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Mangalore, Karnataka, India

Forest Investigative Site 104

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Pune, Maharashtra, India

Forest Investigative Site 105

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Bangalore, Karnataka, India

Forest Investigative Site 111

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Pune, Maharashtra, India

Forest Investigative Site 109

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Kanpur, Uttar Pradesh, India

Forest Investigative Site 004

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Long Beach, California, United States

Forest Investigative Site 005

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Riverside, California, United States

Forest Investigative Site 001

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Flowood, Mississippi, United States

Forest Investigative Site 002

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Houston, Texas, United States

Forest Investigative Site 003

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Creve Couer, Missouri, United States

Forest Investigative Site 010

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Oklahoma City, Oklahoma, United States

Forest Investigative Site 120

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Ahmedabad, Gujarat, India

Forest Investigative Site 103

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Ahmedabad, Gujarat, India

Forest Investigative Site 113

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Mangalore, Karnataka, India

Forest Investigative Site 101

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Aurangabad, Maharashtra, India

Forest Investigative Site 110

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Nasik, Maharashtra, India

Forest Investigative Site 119

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Lucknow, Uttar Pradesh, India

Forest Investigative Site 007

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San Diego, California, United States

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