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

NCT04819776 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 417

Last updated 2024-04-18

Study results available
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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

DRUG

Iloperidone

Oral iloperidone

DRUG

Iloperidone Placebo

Oral placebo

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-22
Primary Completion
2022-09-07
Completion
2023-08-16
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Poland

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04819776 on ClinicalTrials.gov