RecruitingPhase 3NCT06961968

Randomized Withdrawal Study in Patients With Schizophrenia

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

Sponsor

Vanda Pharmaceuticals

Enrollment

400 participants

Start Date

May 14, 2025

Study Type

INTERVENTIONAL

Conditions

Schizophrenia

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This is a study testing a medication for people with schizophrenia who have been stable on treatment but may benefit from continuing their current therapy in a controlled, monitored setting. The trial uses a "randomized withdrawal" design — some participants continue the medication and others are switched to placebo — to see how long the treatment continues to protect against relapse. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with schizophrenia according to standard diagnostic criteria (DSM-5) - You are currently in need of ongoing psychiatric treatment **You may NOT be eligible if...** - You have another psychiatric disorder (besides schizophrenia) that was the main focus of your treatment in the past 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGiloperidone

iloperidone LAI

DRUGplacebo

matching placebo

Locations(22)

Vanda Investigational Site

Rogers, Arkansas, United States

Vanda Investigational Site

Costa Mesa, California, United States

Vanda Investigational Site

Lemon Grove, California, United States

Vanda Investigational Site

Oceanside, California, United States

Vanda Investigational Site

Pico Rivera, California, United States

Vanda Investigational Site

San Diego, California, United States

Vanda Investigational Site

Walnut Creek, California, United States

Vanda Investigational Site

North Miami, Florida, United States

Vanda Investigational Site

Atlanta, Georgia, United States

Vanda Investigational Site

Peachtree Corners, Georgia, United States

Vanda Investigational Site

Chicago, Illinois, United States

Vanda Investigational Site

Flowood, Mississippi, United States

Vanda Investigational Site

Saint Charles, Missouri, United States

Vanda Investigational Site

St Louis, Missouri, United States

Vanda Investigational Site

Las Vegas, Nevada, United States

Vanda Investigational Site

Marlton, New Jersey, United States

Vanda Investigational Site

Staten Island, New York, United States

Vanda Investigational Site

Austin, Texas, United States

Vanda Investigational Site

Houston, Texas, United States

Vanda Investigational Site

Irving, Texas, United States

Vanda Investigational Site

Richardson, Texas, United States

Vanda Investigational Site

Bellevue, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06961968

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