Study of iloperidone for Schizophrenia Symptoms

This study is looking at how well iloperidone long-acting injection (LAI) works to prevent symptoms from getting worse in people with schizophrenia. Researchers want to see if iloperidone LAI is better than a placebo (an inactive substance designed to look like the study drug) at keeping symptoms stable. You may be able to join if you are 18 to 65 years old, have a diagnosis of schizophrenia, and need ongoing psychiatric treatment. The main goal is to see how long it takes for symptoms to worsen over a period of up to 52 weeks. The current status of this study is unclear, but it plans to enroll about 400 participants.

Study design
This is an interventional study comparing iloperidone LAI to a matching placebo. It plans to enroll 400 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 52 weeks after randomization to measure the time to exacerbation of symptoms.

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NCT06961968

Randomized Withdrawal Study in Patients With Schizophrenia

Recruiting
PHASE3Ages 18–65InterventionalTreatment
Vanda Pharmaceuticals
~400 participants
Updated 2026-01-12 on ClinicalTrials.gov
What's tested:iloperidoneplacebo

At a glance

Recruiting sites
22 of 22 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to exacerbation of symptoms
Measured over Up to 52 weeks post-randomization
Schizophrenia
22 sites across 12 states
California6
Texas4
Georgia2
Missouri2
Arkansas1
Florida1
Illinois1
Mississippi1

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Eligibility criteria

Inclusion

Males or females 18 to 65 years of age (inclusive)
Diagnosed with schizophrenia per DSM-5 criteria
In need of ongoing psychiatric treatment

Exclusion

DSM-5 diagnosis of a psychiatric disorder other than schizophrenia that was the primary focus of treatment within the previous six months
  • Time to exacerbation of symptomsUp to 52 weeks post-randomization

    As measured by the time to first exacerbation of psychiatric symptoms