Safety and Tolerability of Open-Labeled Iloperidone in Adolescents

Open-label Safety Study of a 1-year 8 to 24 mg/Day Dose Regimen of Iloperidone (FANAPT®) in Adolescent Patients With Schizophrenia or Bipolar I Disorder

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05648591

Enrollment

100

Registered

2022-12-13

Start date

2023-05-24

Completion date

2026-11-30

Last updated

2025-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia, Bipolar I Disorder

Keywords

fanapt

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.

Interventions

DRUGIloperidone

oral tablet

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 17 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number of participants with treatment-emergent adverse events (TEAEs) in the treatment period.	1 year

Countries

United States

Contacts

Primary ContactVanda Pharmaceuticals Inc.

clinicaltrials@vandapharma.com202-734-3400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026