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

Forest Laboratories

Status and phase

Completed

Phase 2

Conditions

Bipolar Disorder

Treatments

Drug: Cariprazine (RGH-188)

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00488618

RGH-MD-31

Details and patient eligibility

About

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

Enrollment

238 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.