Randomized Withdrawal Study in Patients With Schizophrenia

The purpose of this research is to evaluate the efficacy of dosing iloperidone long-acting injection (LAI) compared to placebo in preventing the exacerbation of symptoms in patients with schizophrenia.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Vanda Investigational Site, Rogers, Arkansas, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iloperidone

Drug

iloperidone LAI

Placebo

Drug

matching placebo

Primary outcomes

Time to exacerbation of symptoms

Time frame: Up to 52 weeks post-randomization

As measured by the time to first exacerbation of psychiatric symptoms

Study contacts

Contact information is provided by the study sponsor or research team.

Vanda Pharmaceuticals Inc.

CONTACT

[email protected]

202-734-3400

Sponsors and collaborators

Lead sponsor

Vanda Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: May 8, 2025
Registry last updated: Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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