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

April 16, 2024 updated by: Vanda Pharmaceuticals

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

417

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Bulgaria
      • Kardzhali, Bulgaria, 6600
        • Vanda Investigational Site
      • Lovech, Bulgaria, 5500
        • Vanda Investigational Site
      • Veliko Tarnovo, Bulgaria, 5000
        • Vanda Investigational Site
      • Vratsa, Bulgaria, 3001
        • Vanda Investigational Site
    • Sofia City
      • Novi Iskar, Sofia City, Bulgaria, 1282
        • Vanda Investigational Site
    • Veliko Tarnovo
      • Tserova Koria, Veliko Tarnovo, Bulgaria, 5047
        • Vanda Investigational Site
  • Poland
      • Tuszyn, Poland, 95-080
        • Vanda Investigational Site
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Vanda Investigational Site
      • Rogers, Arkansas, United States, 72758
        • Vanda Investigational Site
    • California
      • Cerritos, California, United States, 90703
        • Vanda Investigational Site
      • Culver City, California, United States, 90230
        • Vanda Investigational Site
      • Long Beach, California, United States, 90806
        • Vanda Investigational Site
      • Orange, California, United States, 92868
        • Vanda Investigational Site
      • Torrance, California, United States, 90502
        • Vanda Investigational Site
    • Florida
      • Miami Lakes, Florida, United States, 33016
        • Vanda Investigational Site
      • Oakland Park, Florida, United States, 33334
        • Vanda Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Vanda Investigational Site
      • Decatur, Georgia, United States, 30030
        • Vanda Investigational Site
    • Maryland
      • Gaithersburg, Maryland, United States, 20877
        • Vanda Investigational Site
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Vanda Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Vanda Investigational Site
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • Vanda Investigational Site
    • Ohio
      • Dayton, Ohio, United States, 45417
        • Vanda Investigational Site
      • North Canton, Ohio, United States, 44720
        • Vanda Investigational Site
    • Texas
      • Austin, Texas, United States, 78754
        • Vanda Investigational Site
      • DeSoto, Texas, United States, 75115
        • Vanda Investigational Site
      • Richardson, Texas, United States, 75080
        • Vanda Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Iloperidone Placebo
Oral placebo
Experimental: Iloperidone
Drug: Iloperidone
Oral iloperidone
Other Names:
  • VYV-683
  • FANAPT®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanda Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2021

Primary Completion (Actual)

September 7, 2022

Study Completion (Actual)

August 16, 2023

Study Registration Dates

First Submitted

March 24, 2021

First Submitted That Met QC Criteria

March 24, 2021

First Posted (Actual)

March 29, 2021

Study Record Updates

Last Update Posted (Estimated)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VP-VYV-683-3201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bipolar I Disorder

Clinical Trials on Iloperidone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe