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Evaluation of Efficacy and Safety of Iloperidone in the Treatment of Bipolar I Disorder

Sponsor
Vanda Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04819776
Collaborator
(none)
400
Enrollment
3
Locations
2
Arms
25.3
Anticipated Duration (Months)
133.3
Patients Per Site
5.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 22, 2021
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Iloperidone

Drug: Iloperidone
Oral iloperidone
Other Names:
  • FANAPT®
  • VYV-683

    		•
    Placebo Comparator: Placebo

    Drug: Iloperidone Placebo
    Oral placebo

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline in Young Mania Rating Scale (YMRS) total score [Week 4]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vanda Investigational Site Long Beach California United States 90806
    2 Vanda Investigational Site Atlanta Georgia United States 30331
    3 Vanda Investigational Site Marlton New Jersey United States 08053

    Sponsors and Collaborators

    • Vanda Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vanda Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT04819776
    Other Study ID Numbers:
    • VP-VYV-683-3201
    First Posted:
    Mar 29, 2021
    Last Update Posted:
    Mar 29, 2021
    Last Verified:
    Mar 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Disease
    Iloperidone

    Study Results

    No Results Posted as of Mar 29, 2021