Study Evaluating Cariprazine (RGH-188) in the Treatment of Patients With Acute Mania

Study Overview
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Brief Summary
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This is a study designed to evaluate the efficacy, safety, and tolerability of RGH-188 monotherapy in the treatment of acute mania. This study will be 5 weeks in duration; 3 weeks double-blind treatment and 2-weeks safety follow-up. All patients meeting the eligibility criteria will be randomized to one of two treatment groups: RGH-188 or placebo

Official Title
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A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of RGH-188 in Patients With Acute Mania Associated With Bipolar I Disorder

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Drug: Cariprazine (RGH-188)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female inpatients 18 to 65 years of age Meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV) criteria for bipolar I disorder, acute manic or mixed episode Having a total Young Mania Rating Scale (YMRS) score >= 20 and a score of at least 4 on two of the following YMRS items: Irritability, Speech, Content, and Disruptive/Aggressive Behavior Exclusion Criteria: Patients who exhibit abnormalities on physical examination, have abnormal vital-signs, electrocardiogram (ECG), or clinical laboratory values [such as thyroid-stimulating hormone (TSH)]. Patients with Montgomery-Åsberg Depression Rating Scale (MADRS) total score >= 18 at Visit 2. Patients experiencing first manic episode. Patients that have received electroconvulsive therapy (ECT) or a depot neuroleptic in the 3 months prior to Visit 1.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cariprazine<br>Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks. | Drug: Cariprazine (RGH-188)<br>* Cariprazine 3 mg - 12 mg oral administration, once per day.<br>|
| Placebo Comparator: Placebo<br>Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks. | Drug: Placebo<br>* Dose-matched placebo oral administration, once per day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at 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. Analyses are based on an Analysis of Covariance (ANCOVA) model for change from Baseline with treatment group and study center as factors and Baseline value as covariate. | Baseline, Week 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at 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. Analyses are based on ANCOVA model for change from Baseline with treatment group and study center as factors and Baseline CGI-S score as covariate. | Baseline, 3 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mania, Bipolar I Disorder, Acute Mania Associated with Bipolar I Disorder