CClinicalTrials.gg
RecruitingNCT05648591Updated Oct 1, 2026

Safety and Tolerability of Open-Labeled Iloperidone in Adolescents

A Phase 4 interventional study of Iloperidone in Schizophrenia and Bipolar I Disorder, sponsored by Vanda Pharmaceuticals. Recruiting at 11 sites in United States. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by Vanda Pharmaceuticals · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started May 2023; still recruiting 3 years 4 months later.
Updated Oct 1, 2026Site recruiting status changedPrimary completion moved+2 moreGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
12 Years to 17 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Schizophrenia
  • Bipolar I Disorder

Browse trials for

Keywords

  • fanapt
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 471 are open to participants now.

This study's planned enrollment of 100 is above the median of 70 across 2,871 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Vanda Pharmaceuticals is the lead sponsor of 81 studies on the registry; 18 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 22 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Iloperidone

    Open-label iloperidone

    Drug: Iloperidone

Interventions

  • DrugIloperidone

    oral tablet

    Also known as: VYV-683, FANAPT

06

What researchers measure

Primary outcomes

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

    Time frame: 1 year

07

Study locations

11 of 11 sites recruiting
  • Vanda Investigational Site
    Dothan, Alabama 36303, United States
    • · Contact · 202-734-3400
    Recruiting
  • Vanda Investigational Site
    Little Rock, Arkansas 72204, United States
    • · Contact · 202-734-3400
    Recruiting
  • Vanda Investigational Site
    Denver, Colorado 80202, United States
    • · Contact · 202-734-3400
    Recruiting
  • Vanda Investigational Site
    Atlanta, Georgia 30318, United States
    • · Contact · 202-734-3400
    Recruiting
  • Vanda Investigational Site
    Atlanta, Georgia 30331, United States
    • · Contact · 202-734-3400
    Recruiting
  • Vanda Investigational Site
    Decatur, Georgia 30030, United States
    • · Contact · 202-734-3400
    Recruiting
  • Vanda Investigational Site
    Kinston, North Carolina 28501, United States
    • · Contact · 202-734-3400
    Recruiting
  • Vanda Investigational Site
    Cincinnati, Ohio 45221, United States
    • Vanda Pharmaceuticals · Contact · 202-734-3400
    Recruiting
  • Vanda Investigational Site
    Garfield Heights, Ohio 44125, United States
    • · Contact · 202-734-3400
    Recruiting
  • Vanda Investigational Site
    Westlake, Ohio 44145, United States
    • · Contact · 202-734-3400
    Recruiting
  • Vanda Investigational Site
    Everett, Washington 98201, United States
    • · Contact · 202-734-3400
    Recruiting
08

Updates

1 registry update since Sep 25, 2026
Sites
2 sites added. Vanda Investigational Site is now Recruiting
Show 2 added (2 United States)
  • Vanda Investigational Site · Dothan, United States
  • Vanda Investigational Site · Kinston, United States
Oct 1, 2026
Primary completion
Mar 31, 2026→Dec 31, 2028
Oct 1, 2026
Study completion
Nov 30, 2026→Dec 31, 2028
Oct 1, 2026
Show all 1 update
  1. Oct 1, 2026
    2 sites added. Vanda Investigational Site is now Recruiting
    Show 2 added (2 United States)
    • Vanda Investigational Site · Dothan, United States
    • Vanda Investigational Site · Kinston, United States
    Primary completion Mar 31, 2026→Dec 31, 2028
    Study completion Nov 30, 2026→Dec 31, 2028
    + 2 other changes: verification date and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT05648591
Lead sponsor
Vanda Pharmaceuticals
Responsible party
Sponsor
First posted
Dec 13, 2022
Start date
May 24, 2023
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Oct 1, 2026

Study contacts

Vanda Pharmaceuticals Inc.
Contact
clinicaltrials@vandapharma.com
202-734-3400

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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