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Trial record 1 of 1 for:    VP-VYV-683-3201
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Evaluation of Efficacy and Safety of Iloperidone in the Treatment of Bipolar I Disorder

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ClinicalTrials.gov Identifier: NCT04819776
Recruitment Status : Recruiting
First Posted : March 29, 2021
Last Update Posted : March 29, 2021
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals

Study Description
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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
Bipolar I Disorder Drug: Iloperidone Drug: Iloperidone Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 22, 2021
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Iloperidone

Arms and Interventions
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Arm Intervention/treatment
Experimental: Iloperidone Drug: Iloperidone
Oral iloperidone
Other Names:
  • FANAPT®
  • VYV-683
Placebo Comparator: Placebo Drug: Iloperidone Placebo
Oral placebo


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline in Young Mania Rating Scale (YMRS) total score [ Time Frame: Week 4 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04819776


Contacts
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Contact: Vanda Pharmaceuticals 202-734-3400 clinicaltrials@vandapharma.com

Locations
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United States, California
Vanda Investigational Site Recruiting
Long Beach, California, United States, 90806
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Georgia
Vanda Investigational Site Recruiting
Atlanta, Georgia, United States, 30331
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, New Jersey
Vanda Investigational Site Recruiting
Marlton, New Jersey, United States, 08053
Contact: Vanda Pharmaceuticals    202-734-3400      
Sponsors and Collaborators
Vanda Pharmaceuticals
More Information
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Responsible Party: Vanda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04819776    
Other Study ID Numbers: VP-VYV-683-3201
First Posted: March 29, 2021    Key Record Dates
Last Update Posted: March 29, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Pathologic Processes
Iloperidone
Antipsychotic Agents
 Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs