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
1 other identifier
interventional
100
1 country
11
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 schizophrenia
Started May 2023
Longer than P75 for phase_4 schizophrenia
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2022
CompletedFirst Posted
Study publicly available on registry
December 13, 2022
CompletedStudy Start
First participant enrolled
May 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
October 1, 2026
September 1, 2026
5.6 years
December 5, 2022
September 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with treatment-emergent adverse events (TEAEs) in the treatment period.
1 year
Study Arms (1)
Iloperidone
EXPERIMENTALOpen-label iloperidone
Interventions
Eligibility Criteria
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 (11)
Vanda Investigational Site
Dothan, Alabama, 36303, United States
Vanda Investigational Site
Little Rock, Arkansas, 72204, United States
Vanda Investigational Site
Denver, Colorado, 80202, United States
Vanda Investigational Site
Atlanta, Georgia, 30318, United States
Vanda Investigational Site
Atlanta, Georgia, 30331, United States
Vanda Investigational Site
Decatur, Georgia, 30030, United States
Vanda Investigational Site
Kinston, North Carolina, 28501, United States
Vanda Investigational Site
Cincinnati, Ohio, 45221, United States
Vanda Investigational Site
Garfield Heights, Ohio, 44125, United States
Vanda Investigational Site
Westlake, Ohio, 44145, United States
Vanda Investigational Site
Everett, Washington, 98201, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
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 (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
October 1, 2026
Record last verified: 2026-09