SchizophreniaPhase 4NCT05648591
Safety and Tolerability of Open-Labeled Iloperidone in Adolescents
A Phase 4 study testing Iloperidone in people with Schizophrenia and Bipolar I Disorder, run by Vanda Pharmaceuticals at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Schizophrenia, Bipolar I Disorder
- What is being tested?
- Iloperidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 11 sitesUnited States
- Study dates
- 24 May 2023to 31 Dec 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites, 11 recruiting
- Recruiting
Vanda Investigational Site
Atlanta, Georgia, 30318
202-734-3400
- Recruiting
Vanda Investigational Site
Atlanta, Georgia, 30331
202-734-3400
- Recruiting
Vanda Investigational Site
Cincinnati, Ohio, 45221
Vanda Pharmaceuticals, 202-734-3400
- Recruiting
Vanda Investigational Site
Decatur, Georgia, 30030
202-734-3400
- Recruiting
Vanda Investigational Site
Denver, Colorado, 80202
202-734-3400
- Recruiting
Vanda Investigational Site
Dothan, Alabama, 36303
202-734-3400
- Recruiting
Vanda Investigational Site
Everett, Washington, 98201
202-734-3400
- Recruiting
Vanda Investigational Site
Garfield Heights, Ohio, 44125
202-734-3400
- Recruiting
Vanda Investigational Site
Kinston, North Carolina, 28501
202-734-3400
- Recruiting
Vanda Investigational Site
Little Rock, Arkansas, 72204
202-734-3400
- Recruiting
Vanda Investigational Site
Westlake, Ohio, 44145
202-734-3400
About this study
Official title: 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
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
- Being tested
- Iloperidone
- Keywords
- fanapt
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IloperidoneDrug
Also called VYV-683, FANAPT
oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Iloperidone | Experimental | Open-label iloperidone Receives: Drug: Iloperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-emergent adverse events (TEAEs) in the treatment period.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start24 May 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648591
- Sponsor's protocol ID
- VP-VYV-683-4101
- Status last verified
- Sep 2026
- First submitted
- 5 Dec 2022
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No