Study Evaluating Cariprazine (RGH-188) in the Treatment of Patients With Acute Mania
- Registration Number
- NCT00488618
- Lead Sponsor
- Forest Laboratories
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 238
-
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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cariprazine Cariprazine (RGH-188) Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks. Placebo Placebo Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
- Primary Outcome Measures
Name Time Method Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3 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. 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3 Baseline, 3 Weeks 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.
Trial Locations
- Locations (1)
For information regarding investigative sites, contact Forest Professional Affairs
🇺🇸St. Louis, Missouri, United States