Clinical Trials Logo
  1. Home
  2. Bipolar I Disorder
  3. NCT04819776
  4. Details
NCT04819776 Clinical Trial

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

Bipolar I Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04819776
Other study ID # VP-VYV-683-3201
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date March 22, 2021
Est. completion date August 16, 2023

Study information
Verified date April 2024
Source Vanda Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 417
Est. completion date August 16, 2023
Est. primary completion date September 7, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Iloperidone
Oral iloperidone
• Iloperidone Placebo
Oral placebo

Locations
Country Name City State
Bulgaria Vanda Investigational Site Kardzhali
Bulgaria Vanda Investigational Site Lovech
Bulgaria Vanda Investigational Site Novi Iskar Sofia City
Bulgaria Vanda Investigational Site Tserova Koria Veliko Tarnovo
Bulgaria Vanda Investigational Site Veliko Tarnovo
Bulgaria Vanda Investigational Site Vratsa
Poland Vanda Investigational Site Tuszyn
United States Vanda Investigational Site Atlanta Georgia
United States Vanda Investigational Site Austin Texas
United States Vanda Investigational Site Cerritos California
United States Vanda Investigational Site Culver City California
United States Vanda Investigational Site Dayton Ohio
United States Vanda Investigational Site Decatur Georgia
United States Vanda Investigational Site DeSoto Texas
United States Vanda Investigational Site Flowood Mississippi
United States Vanda Investigational Site Gaithersburg Maryland
United States Vanda Investigational Site Las Vegas Nevada
United States Vanda Investigational Site Little Rock Arkansas
United States Vanda Investigational Site Long Beach California
United States Vanda Investigational Site Marlton New Jersey
United States Vanda Investigational Site Miami Lakes Florida
United States Vanda Investigational Site North Canton Ohio
United States Vanda Investigational Site Oakland Park Florida
United States Vanda Investigational Site Orange California
United States Vanda Investigational Site Richardson Texas
United States Vanda Investigational Site Rogers Arkansas
United States Vanda Investigational Site Torrance California

Sponsors (1)
Lead Sponsor Collaborator
Vanda Pharmaceuticals

Countries where clinical trial is conducted

United States,  Bulgaria,  Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change From Baseline to Week 4 in Young Mania Rating Scale (YMRS) Total Score 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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03641300 - Efficacy of Convulsive Therapies for Bipolar Depression N/A
Withdrawn NCT01495156 - Study of the Efficacy of Adjunctive Lithium Treatment for the Treatment of Psychotic Mania Phase 4
Completed NCT00982020 - Study in Adolescents With Schizophrenia or Bipolar Disorder Phase 4
Completed NCT00746343 - Reducing Medical Risks in Individuals With Bipolar Disorder - Full Study N/A
Completed NCT00177463 - L-Carnosine for Bipolar I Disorder N/A
Completed NCT03257865 - A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes, Associated With Bipolar I Disorder Phase 3
Completed NCT03259555 - A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes Associated With Bipolar I Disorder Phase 3
Not yet recruiting NCT06433635 - Sequential Multiple Assignment Randomized Trial for Bipolar Depression Phase 4
Completed NCT04127058 - Evaluating a New Iloperidone Titration Scheme in Bipolar I Disorder or Schizophrenia Phase 1
Recruiting NCT05977023 - NMDA Receptor Modulation for the Treatment of Bipolar I Disorder Phase 2
Recruiting NCT05340686 - Braining- Aerobic Physical Activity as Add on Treatment in Bipolar Depression N/A
Completed NCT03287869 - A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Participants With Bipolar I Disorder. Phase 3
Enrolling by invitation NCT04987229 - Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects Phase 3
Completed NCT00761761 - Sensoril(Ashwaganhda)for Bipolar Disorder Phase 3
Completed NCT00232414 - A Double-Blind Randomized Placebo Controlled Study of Quetiapine for the Treatment of Depression in Adolescents With Bipolar Disorder Phase 3
Completed NCT03292848 - Trial to Assess the Pharmacokinetics, Safety, Tolerability of Oral Brexpiprazole in Children (6 to <13 Years Old) With Central Nervous System Disorders Phase 1
Active, not recruiting NCT04561622 - Emotional Proactive Processing in Bipolar Disorder
Recruiting NCT03943537 - Effects of Intranasal Insulin on Neuroimaging Markers and Cognition in Patients With Psychotic Disorders Phase 2
Completed NCT03334721 - Gabapentin for Bipolar & Cannabis Use Disorders Phase 2
Active, not recruiting NCT05658510 - Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III) Phase 3