Trials / Completed
CompletedNCT04819776
Evaluation of Efficacy and Safety of Iloperidone in the Acute Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 417 (actual)
- Sponsor
- Vanda Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Iloperidone | Oral iloperidone |
| DRUG | Iloperidone Placebo | Oral placebo |
Timeline
- Start date
- 2021-03-22
- Primary completion
- 2022-09-07
- Completion
- 2023-08-16
- First posted
- 2021-03-29
- Last updated
- 2024-04-18
- Results posted
- 2024-04-16
Locations
27 sites across 3 countries: United States, Bulgaria, Poland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04819776. Inclusion in this directory is not an endorsement.