Evaluation of Efficacy and Safety of Iloperidone in the Acute Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder
- Registration Number
- NCT04819776
- Lead Sponsor
- Vanda Pharmaceuticals
- Brief Summary
The aim of this study is to investigate the efficacy, safety, and tolerability of iloperidone compared with placebo in treating acute manic or mixed episodes associated with Bipolar I Disorder.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 417
Inclusion Criteria
- Male or female patients 18 to 65 years of age (inclusive)
- Diagnosed with bipolar I disorder, manic or mixed-type, per DSM-5 criteria
- Voluntary hospitalization for current manic episode
Exclusion Criteria
- Patients with a DSM-5 diagnosis of a psychiatric disorder other than bipolar I disorder that was the primary focus of treatment within the previous six months
- Patients who are experiencing a first manic episode or meeting criteria for rapid cycling
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Iloperidone Placebo - Iloperidone Iloperidone -
- Primary Outcome Measures
Name Time Method Change From Baseline to Week 4 in Young Mania Rating Scale (YMRS) Total Score Week 4 The Young Mania Rating Scale (YMRS) is an 11-item scale. Individual item scores are summed for a total possible score of 0 (best) to 60 (worst).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Vanda Investigational Site
🇵🇱Tuszyn, Poland