Study Evaluating Cariprazine (RGH-188) in the Treatment of Patients With Acute Mania
Completed · Phase 2 · Has a placebo group
Conditions studied: Bipolar Disorder
In brief
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
Key facts
- Study ID
- NCT00488618
- Run by
- Forest Laboratories
- People needed
- 238
- Starts
- 2007-06-01
- Expected to finish
- 2008-07-01
- Last updated by the study team
- 2017-04-14
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- For information regarding investigative sites, contact Forest Professional Affairs — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.