Phase 2
Completed N=238
Study Evaluating Cariprazine (RGH-188) in the Treatment of Patients With Acute Mania
Source: ClinicalTrials.gov NCT00488618 ↗Enrolled (actual)
238
Serious AEs
5.5%
Results posted
Apr 2017
Primary outcomePrimary: Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3 — -8.91; -15.02 score on a scale — p=<0.0001
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3 |
-8.91; -15.02 | <0.0001 sig |
| SECONDARY Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3 |
-0.93; -1.57 | 0.0001 sig |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00488618). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.