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Completed Phase 3 Interventional Results available

Evaluation of Efficacy and Safety of Iloperidone in the Acute Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder

ClinicalTrials.gov ID: NCT04819776

Public ClinicalTrials.gov record NCT04819776. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 30, 2026, 10:21 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT04819776
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Vanda Pharmaceuticals
Industry
Enrollment
417 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 22, 2021 (Actual)
Primary completion
Sep 7, 2022 (Actual)
Completion
Aug 16, 2023 (Actual)
Last update posted
Apr 18, 2024

2021 – 2023

United States locations

U.S. sites
20
U.S. states
10
U.S. cities
20
Facility City State ZIP Site status
Vanda Investigational Site Little Rock Arkansas 72211 —
Vanda Investigational Site Rogers Arkansas 72758 —
Vanda Investigational Site Cerritos California 90703 —
Vanda Investigational Site Culver City California 90230 —
Vanda Investigational Site Long Beach California 90806 —
Vanda Investigational Site Orange California 92868 —
Vanda Investigational Site Torrance California 90502 —
Vanda Investigational Site Miami Lakes Florida 33016 —
Vanda Investigational Site Oakland Park Florida 33334 —
Vanda Investigational Site Atlanta Georgia 30331 —
Vanda Investigational Site Decatur Georgia 30030 —
Vanda Investigational Site Gaithersburg Maryland 20877 —
Vanda Investigational Site Flowood Mississippi 39232 —
Vanda Investigational Site Las Vegas Nevada 89102 —
Vanda Investigational Site Marlton New Jersey 08053 —
Vanda Investigational Site Dayton Ohio 45417 —
Vanda Investigational Site North Canton Ohio 44720 —
Vanda Investigational Site Austin Texas 78754 —
Vanda Investigational Site DeSoto Texas 75115 —
Vanda Investigational Site Richardson Texas 75080 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04819776, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 18, 2024 · Synced Oct 30, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04819776 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →