A Comparison of Long-acting Injectable Medications for Schizophrenia

Completed · Phase 4

Conditions studied: Schizophrenia, Schizoaffective Disorder

In brief

The purpose of this research study is to compare the "real-world" effectiveness of two FDA-approved and widely used long-acting injectable antipsychotic medications (paliperidone palmitate and haloperidol decanoate) in patients with schizophrenia or schizoaffective disorder who are expected to benefit from the improved medication compliance associated with injectable medications. The goal is to evaluate the effects of the medications on outcomes of importance to patients (relapse, symptoms, adverse effects, functioning) as well as policy makers (all of the above plus costs).

Key facts

Study ID

NCT01136772

Run by

New York State Psychiatric Institute

People needed

311

Starts

2011-03-01

Expected to finish

2016-07-01

Last updated by the study team

2016-10-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of schizophrenia or schizoaffective disorder as defined by DSM-IV-TR criteria
• Age 18-65 years
• Capacity to provide informed consent
• Patients who are likely to benefit from treatment with long-acting injectable paliperidone palmitate or haloperidol decanoate
• Women of child bearing potential must have a negative serum pregnancy test at the Screening Visit.

You may not qualify if…

• Patients who are currently stable and doing well on an antipsychotic regimen
• Patients not expected to benefit from the study medications due to past experience with risperidone, paliperidone or haloperidol
• Patients with tardive dyskinesia that is moderate or severe
• Patients with any medical condition that, in the judgment of the investigator, might preclude safe completion of the study
• Women who are pregnant or breastfeeding
• Patients with mental retardation

Where it is running

• VA Palo Alto Heathcare Systems — Palo Alto, California, United States
• Yale University/Connecticut Mental Health Center — New Haven, Connecticut, United States
• University of Miami School of Medicine — Miami, Florida, United States
• Medical College of Georgia — Augusta, Georgia, United States
• University of Iowa Hospital — Iowa City, Iowa, United States
• Clinical Research Institute — Wichita, Kansas, United States
• Clinical Insights, Inc. — Glen Burnie, Maryland, United States
• John D. Dingell VA Medical Center — Detroit, Michigan, United States
• Sparrow St. Lawrence Hospital, Michigan State University Psychiatry — Lansing, Michigan, United States
• Kansas City Veterans Affairs Medical Center — Kansas City, Missouri, United States
• Creighton University Dept. of Psychiatry — Omaha, Nebraska, United States
• Research Foundation for Mental Hygiene — New York, New York, United States
• University of Rochester — Rochester, New York, United States
• John Umstead Hospital/Duke University — Butner, North Carolina, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Carolina Behavioral Care — Durham, North Carolina, United States
• Louis Stokes Cleveland VA Medical Center — Brecksville, Ohio, United States
• Philadelphia VA Medical Center-116A — Philadelphia, Pennsylvania, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Central Texas Veterans Health Care System — Waco, Texas, United States
• Frontier Institute — Spokane, Washington, United States
• VA Puget Sound Health Care System — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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