NCT05648591

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4 schizophrenia

Timeline
7mo left

Started May 2023

Typical duration for phase_4 schizophrenia

Geographic Reach
1 country

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
May 2023Nov 2026

First Submitted

Initial submission to the registry

December 5, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 13, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

May 24, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Expected
Last Updated

March 4, 2025

Status Verified

February 1, 2025

Enrollment Period

2.9 years

First QC Date

December 5, 2022

Last Update Submit

February 27, 2025

Conditions

SchizophreniaBipolar I Disorder

Keywords

fanapt

Outcome Measures

Primary Outcomes (1)

  • Number of participants with treatment-emergent adverse events (TEAEs) in the treatment period.

    1 year

Study Arms (1)

Iloperidone

EXPERIMENTAL

Open-label iloperidone

Drug: Iloperidone

Interventions

IloperidoneDRUG

oral tablet

Also known as: VYV-683, FANAPT
Iloperidone

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Vanda Investigational Site

Little Rock, Arkansas, 72204, United States

RECRUITING

Vanda Investigational Site

Denver, Colorado, 80202, United States

RECRUITING

Vanda Investigational Site

Atlanta, Georgia, 30318, United States

RECRUITING

Vanda Investigational Site

Atlanta, Georgia, 30331, United States

RECRUITING

Vanda Investigational Site

Decatur, Georgia, 30030, United States

RECRUITING

Vanda Investigational Site

Cincinnati, Ohio, 45221, United States

RECRUITING

Vanda Investigational Site

Garfield Heights, Ohio, 44125, United States

RECRUITING

Vanda Investigational Site

Westlake, Ohio, 44145, United States

NOT YET RECRUITING

Vanda Investigational Site

Everett, Washington, 98201, United States

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Interventions

iloperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Central Study Contacts

Vanda Pharmaceuticals Inc.

CONTACT

202-734-3400clinicaltrials@vandapharma.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2022

First Posted

December 13, 2022

Study Start

May 24, 2023

Primary Completion

March 31, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

March 4, 2025

Record last verified: 2025-02

Locations

US(9)