At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 417 enrolled
Drug / intervention
Iloperidone +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Iloperidone for 4 Weeks in the Treatment of Patients With Acute Manic Episodes Associated With Bipolar I Disorder
In Brief
A Phase 3 clinical trial evaluating Iloperidone and Iloperidone Placebo for Bipolar I Disorder. Completed, enrolled 417 participants across 27 sites in 3 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar I Disorder
CountriesBulgaria, Poland, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
Enrollment StartMar 2021
First PostedMar 2021
Primary CompletionSep 2022
Study CompletionAug 2023
TodayJul 2026
First PostedMar 29, 2021
Enrollment StartMar 22, 2021
Primary CompletionSep 7, 2022
Study CompletionAug 16, 2023
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 5.3 years ago
Interventions
Iloperidonedrug
Oral iloperidone
Iloperidone Placebodrug
Oral placebo