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NCT06961968PHASE3Recruiting

Randomized Withdrawal Study in Patients With Schizophrenia

Vanda Pharmaceuticals

Start Date

5/14/2025

Completion Date

11/1/2027

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 Criteria

Age Range: 18 years to 65 years

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

Interventions

DRUG

iloperidone

DRUG

placebo

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Conditions

Schizophrenia

Locations

Vanda Investigational Site

Rogers, Arkansas 72758

United States

Vanda Investigational Site

Costa Mesa, California 92626

United States

Vanda Investigational Site

Lemon Grove, California 91945

United States

Vanda Investigational Site

Oceanside, California 92056

United States

Vanda Investigational Site

Pico Rivera, California 90660

United States

Vanda Investigational Site

San Diego, California 92123

United States

Vanda Investigational Site

Walnut Creek, California 94596

United States

Vanda Investigational Site

North Miami, Florida 33161

United States

Vanda Investigational Site

Atlanta, Georgia 30328

United States

Vanda Investigational Site

Peachtree Corners, Georgia 30071

United States

Vanda Investigational Site

Chicago, Illinois 60641

United States

Vanda Investigational Site

Flowood, Mississippi 39232

United States

Vanda Investigational Site

Saint Charles, Missouri 63304

United States

Vanda Investigational Site

St Louis, Missouri 63141

United States

Vanda Investigational Site

Las Vegas, Nevada 89119

United States

Vanda Investigational Site

Marlton, New Jersey 08053

United States

Vanda Investigational Site

Staten Island, New York 10314

United States

Vanda Investigational Site

Austin, Texas 78754

United States

Vanda Investigational Site

Houston, Texas 77081

United States

Vanda Investigational Site

Irving, Texas 75062

United States

Vanda Investigational Site

Richardson, Texas 75080

United States

Vanda Investigational Site

Bellevue, Washington 98007

United States