Recruiting

Iloperidone

Sponsor:

Vanda Pharmaceuticals

Code:

NCT05648591

Conditions

Schizophrenia

Bipolar I Disorder

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

Iloperidone

Study Details

Brief summary:

To evaluate the safety and tolerability of iloperidone in adolescent patients with schizophrenia or bipolar I disorder for up to 52 weeks of treatment.

Conditions

Schizophrenia

Bipolar I Disorder

Study ID

NCT05648591

Start date

May 24, 2023

Status verified date

Feb, 2025

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Mar 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patient is willing and able to provide assent and willing to complete all aspects of the study
  • Patient's parent or legal guardian willing and able to provide consent
  • Male or female patients 12 through 17 years of age (inclusive)
  • Clinical diagnosis of either schizophrenia or bipolar I disorder

Exclusion Criteria:

  • Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
  • A positive test for drugs of abuse

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Iloperidone

Open-label iloperidone

Interventions

Iloperidone

oral tablet

Primary outcome measure

  • Number of participants with treatment-emergent adverse events (TEAEs) in the treatment period. [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Vanda Pharmaceuticals Inc.

202-734-3400clinicaltrials@vandapharma.com

Locations

Vanda Investigational Site

Recruiting

Little Rock, Arkansas, United States, 72204

Contacts

202-734-3400

Vanda Investigational Site

Recruiting

Denver, Colorado, United States, 80202

Contacts

202-734-3400

Vanda Investigational Site

Recruiting

Atlanta, Georgia, United States, 30318

Contacts

202-734-3400

Vanda Investigational Site

Recruiting

Atlanta, Georgia, United States, 30331

Contacts

202-734-3400

Vanda Investigational Site

Recruiting

Decatur, Georgia, United States, 30030

Contacts

202-734-3400

Vanda Investigational Site

Recruiting

Cincinnati, Ohio, United States, 45221

Contacts

Vanda Pharmaceuticals

202-734-3400

Vanda Investigational Site

Recruiting

Garfield Heights, Ohio, United States, 44125

Contacts

202-734-3400

Vanda Investigational Site

Recruiting

Everett, Washington, United States, 98201

Contacts

202-734-3400

More Information

Sponsor

Vanda Pharmaceuticals

Last update posted

Mar 4, 2025

Last verified

Feb, 2025

Keywords

  • fanapt

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanda Pharmaceuticals on 2025-03-04.