Randomized Withdrawal Study in Patients With Schizophrenia

NCT06961968 · tracked via the Priya Life Science USA tracker

Sponsor

Vanda Pharmaceuticals

Phase

Phase 3

Started

2025-05-14

Last updated

2026-01-12

Condition(s) studied

Schizophrenia

Investigational drug(s) / intervention(s)

iloperidone →placebo

iloperidone: iloperidone LAI

placebo: matching placebo

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

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

Primary outcome measure(s)

Time to exacerbation of symptoms — Up to 52 weeks post-randomization
As measured by the time to first exacerbation of psychiatric symptoms

Trial sites (22)

Facility	City	Region	Status
Vanda Investigational Site	Rogers	Arkansas	Recruiting
Vanda Investigational Site	Costa Mesa	California	Recruiting
Vanda Investigational Site	Lemon Grove	California	Recruiting
Vanda Investigational Site	Oceanside	California	Recruiting
Vanda Investigational Site	Pico Rivera	California	Recruiting
Vanda Investigational Site	San Diego	California	Recruiting
Vanda Investigational Site	Walnut Creek	California	Recruiting
Vanda Investigational Site	North Miami	Florida	Recruiting
Vanda Investigational Site	Atlanta	Georgia	Recruiting
Vanda Investigational Site	Peachtree Corners	Georgia	Recruiting
Vanda Investigational Site	Chicago	Illinois	Recruiting
Vanda Investigational Site	Flowood	Mississippi	Recruiting
Vanda Investigational Site	Saint Charles	Missouri	Recruiting
Vanda Investigational Site	St Louis	Missouri	Recruiting
Vanda Investigational Site	Las Vegas	Nevada	Recruiting
Vanda Investigational Site	Marlton	New Jersey	Recruiting
Vanda Investigational Site	Staten Island	New York	Recruiting
Vanda Investigational Site	Austin	Texas	Recruiting
Vanda Investigational Site	Houston	Texas	Recruiting
Vanda Investigational Site	Irving	Texas	Recruiting
Vanda Investigational Site	Richardson	Texas	Recruiting
Vanda Investigational Site	Bellevue	Washington	Recruiting

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Other trials for the same condition

A Study of the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06961968 on ClinicalTrials.gov ↗ ← All trials in the USA