Phase 3
Completed N=414
Evaluation of Efficacy and Safety of Iloperidone in the Acute Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder
Source: ClinicalTrials.gov NCT04819776 ↗Enrolled (actual)
414
Serious AEs
1.2%
Results posted
Apr 2024
Primary outcomePrimary: 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
◆ Published Evidence
Emerging
9citations · ~5 / year
Efficacy and Safety of Iloperidone in Bipolar Mania: A Double-Blind, Placebo-Controlled Study.
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.
Linked Publications
-
Efficacy and Safety of Iloperidone in Bipolar Mania: A Double-Blind, Placebo-Controlled Study.
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 | — |
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) and the linked publication. 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.