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

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

Inclusion Criteria3

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

Exclusion Criteria1

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

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

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NCT06961968


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