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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-07-31

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

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Detailed Description

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Conditions

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Bipolar Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Cariprazine

Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.

Group Type EXPERIMENTAL

Cariprazine (RGH-188)

Intervention Type DRUG

Cariprazine 3 mg - 12 mg oral administration, once per day.

Placebo

Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Dose-matched placebo oral administration, once per day.

Interventions

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Cariprazine (RGH-188)

Cariprazine 3 mg - 12 mg oral administration, once per day.

Intervention Type DRUG

Placebo

Dose-matched placebo oral administration, once per day.

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No