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Testing whether stopping iloperidone long-acting injection causes symptom return in adults with schizophrenia.

A Multicenter, Double-Blind, Randomized Withdrawal Study in Patients With Schizophrenia Receiving Either Iloperidone Long-Acting Injection (LAI) or Placebo Injection

Phase 3 Interventional Vanda Pharmaceuticals · NCT06961968

This trial tests whether iloperidone long-acting injection prevents symptom worsening compared with placebo in adults with schizophrenia.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment400 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorVanda Pharmaceuticals Industry-sponsored
Locations22 sites (Rogers, Arkansas and 21 other locations)
Trial IDNCT06961968 on ClinicalTrials.gov

What this trial studies

This Phase 3 randomized withdrawal trial will compare iloperidone long-acting injection to placebo in adults with schizophrenia to see whether continued active treatment reduces symptom exacerbation. Eligible adults (18–65) with a DSM-5 diagnosis of schizophrenia who need ongoing psychiatric treatment are randomized to receive either iloperidone LAI or placebo and are followed for return or worsening of symptoms. Standard clinical and safety assessments are used during the follow-up period to detect exacerbations and adverse events. The trial is run at three Vanda investigational sites in the United States.

Who should consider this trial

Good fit: Adults aged 18–65 with a DSM-5 diagnosis of schizophrenia who require ongoing psychiatric treatment are the intended participants.

Not a fit: People younger than 18 or older than 65, or those whose primary recent psychiatric diagnosis was not schizophrenia, are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, continued iloperidone LAI could reduce relapse and hospitalizations by keeping symptoms stable.

How similar studies have performed: Other long-acting injectable antipsychotics have reduced relapse in randomized withdrawal trials, but published data specifically on iloperidone LAI are limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

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

Exclusion Criteria:

* DSM-5 diagnosis of a psychiatric disorder other than schizophrenia that was the primary focus of treatment within the previous six months

Where this trial is running

Rogers, Arkansas and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions SchizophreniaAntipsychotic AgentsIloperidoneLong-Acting InjectionRandomized Withdrawal
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.