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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Vanda Investigational Site
  Rogers, Arkansas, United States Recruiting
• Vanda Investigational Site
  Costa Mesa, California, United States Recruiting
• Vanda Investigational Site
  Lemon Grove, California, United States Recruiting
• Vanda Investigational Site
  Oceanside, California, United States Recruiting
• Vanda Investigational Site
  Pico Rivera, California, United States Recruiting
• Vanda Investigational Site
  San Diego, California, United States Recruiting

Study contacts

• Study coordinator: Vanda Pharmaceuticals Inc.
• Email: clinicaltrials@vandapharma.com
• Phone: 202-734-3400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.