Phase 3
N=414
Evaluation of Efficacy and Safety of Iloperidone in the Acute Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder
Bipolar I Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04819776 ↗Enrolled (actual)
414
Serious AEs
1.2%
Results posted
Apr 2024
Primary outcome: Primary: Change From Baseline to Week 4 in Young Mania Rating Scale (YMRS) Total Score — -14.0; -10.0 Change from Baseline in YMRS Total Score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Iloperidone (Drug); Iloperidone Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanda Pharmaceuticals
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 4 in Young Mania Rating Scale (YMRS) Total Score |
-14.0; -10.0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04819776). 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.