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OpenTrials
Completed

NCT Number: NCT04819776

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.

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Key information

Conditions

Bipolar I Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Vanda Investigational Site, Novi Iskar, Sofia-Grad, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patients 18 to 65 years of age (inclusive)
  • Diagnosed with bipolar I disorder, manic or mixed-type, per DSM-5 criteria
  • Voluntary hospitalization for current manic episode

Exclusion criteria

  • Patients with a DSM-5 diagnosis of a psychiatric disorder other than bipolar I disorder that was the primary focus of treatment within the previous six months
  • Patients who are experiencing a first manic episode or meeting criteria for rapid cycling

Treatment and study plan

iloperidone

Drug

Oral iloperidone

Other names: FANAPT®, VYV-683

Iloperidone Placebo

Drug

Oral placebo

Primary outcomes

  1. Change From Baseline to Week 4 in Young Mania Rating Scale (YMRS) Total Score

    Time frame: Week 4

    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).

Sponsors and collaborators

Lead sponsor

Vanda Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Mar 29, 2021
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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