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NCT04819776 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Efficacy and Safety of Iloperidone in the Acute Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder
A Phase 3 study, sponsored by Vanda Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 417
- Enrollment target
NCT04819776: Completed Phase 3 study, sponsored by Vanda Pharmaceuticals.
NCT04819776 is a Phase 3 study that has completed, run by Vanda Pharmaceuticals. The registered enrollment target is 417 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04819776, a Phase 3 study, has completed, sponsored by Vanda Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 417 participants
- Enrollment target
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.
Primary Outcome
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).
Interventions
- DRUG Iloperidone
- DRUG Iloperidone Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 417 participants |
| Start Date | 2021-03-22 |
| Est. Completion | 2023-08-16 |
| Phase | Phase 3 |
What the finished NCT04819776 record still lists
NCT04819776 is an interventional study that assigns participants to a tested intervention. The registered 417 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower).
The record links to 0 conditions, and to 2 interventions - of which Iloperidone is the first listed.
NCT04819776 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04819776 about?
NCT04819776 is a clinical study titled "Evaluation of Efficacy and Safety of Iloperidone in the Acute Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder". 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.
What is the current status of trial NCT04819776?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 417 participants. The study started on 2021-03-22. Estimated completion is 2023-08-16.
What interventions are being tested in trial NCT04819776?
The interventions under investigation include: Iloperidone (DRUG), Iloperidone Placebo (DRUG).
Who is sponsoring clinical trial NCT04819776?
This trial is sponsored by Vanda Pharmaceuticals, which has 68 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04819776's enrollment target sits among peer trials
417 902nd of 2000 higher than 1,099 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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