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

Recruitment Status: COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified March 2024 by Vanda Pharmaceuticals
Sponsor: Vanda Pharmaceuticals
Information Provided by (Responsible Party): Vanda Pharmaceuticals

Clinicaltrials.gov Identifier: NCT04819776
Other Study ID Numbers:: VP-VYV-683-3201

First Submitted: March 23, 2021
First Posted: March 28, 2021
Results First Posted: March 18, 2024
Last Update Posted: April 17, 2024
Last Verified: March 2024

ClinicalTrials.gov processed this data on April 2024. Link to the current ClinicalTrials.gov record .

Study Details

Study Description

Condition or Disease	Intervention/Treatment
Bipolar I Disorder	Drug: IloperidoneDrug: Iloperidone Placebo

Study Design

Study Type	Interventional
Actual Enrollment	417 participants
Design Allocation	Randomized
Interventional Model	Parallel Assignment
Masking	Quadruple
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
Study Start Date	March 21, 2021
Actual Primary Completion Date	September 6, 2022
Actual Study Completion Date	August 15, 2023

Groups and Cohorts

Group/Cohort	Intervention/Treatment
Iloperidone	Drug: Iloperidone Oral iloperidone
Placebo	Drug: Iloperidone Placebo Oral placebo

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Ages Eligible for Study	(Adult, Older Adult)
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

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

Sponsors and Collaborators

Vanda Pharmaceuticals

Locations

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

Study Documents (Full Text)

Documents provided by Vanda Pharmaceuticals: Study Protocol and Statistical Analysis Plan November 16, 2021

More Information

Publications

Torres R, Czeisler EL, Chadwick SR, Stahl SM, Smieszek SP, Xiao C, Polymeropoulos CM, Birznieks G, Polymeropoulos MH. Efficacy and Safety of Iloperidone in Bipolar Mania: A Double-Blind, Placebo-Controlled Study. J Clin Psychiatry. 2024 Jan 15;85(1):23m14966. doi: 10.4088/JCP.23m14966.