A Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of Cariprazine in Patients With Acute Mania Associated With Bipolar I Disorder
Overview
- Phase
- Phase 3
- Intervention
- Cariprazine
- Conditions
- Mania
- Sponsor
- Forest Laboratories
- Enrollment
- 497
- Locations
- 66
- Primary Endpoint
- Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
Cariprazine (3-6 mg/day)
Cariprazine 3 milligrams (mg) - 6 mg capsules oral administration, once per day for 3 weeks.
Intervention: Cariprazine
Cariprazine (6-12 mg/day)
Cariprazine 6 mg - 12 mg capsules oral administration, once per day for 3 weeks.
Intervention: Cariprazine
Placebo
Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
Intervention: Placebo
Outcomes
Primary Outcomes
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 Outcomes
- Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3(Baseline, Week 3)