Preventing Relapse in Schizophrenia: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy

Completed · Phase 4

Conditions studied: Schizophrenia, Schizoaffective Disorder

In brief

This study is designed to find out whether taking antipsychotic medication once every two weeks by injection compared to taking daily oral medication will help people with schizophrenia maintain better control of their symptoms.

Key facts

Study ID

NCT00330863

Run by

Northwell Health

People needed

357

Starts

2006-05-01

Expected to finish

2011-01-01

Last updated by the study team

2018-07-10

Who can join

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

You may qualify if…

• All schizophrenia and schizoaffective patients whose clinicians are considering long-term treatment with an "atypical" (second generation) antipsychotic medication
• Worsening of illness (schizophrenia) within 12 months of study entry as defined by: hospitalization, increased level of clinical care, and/or present clinical Global Impressions Severity rating of moderate or worse

You may not qualify if…

• First episode patients as defined by a patient who: has never received antipsychotic medication and has never been hospitalized for psychiatric illness; or, is receiving antipsychotic medication for the first time associated with a first diagnosis of schizophrenia.
• Pregnant or breastfeeding
• Patients with unstable medical conditions
• Patients with previous history of failure to respond to an adequate trial of clozapine
• Patients with a known allergy to risperidone or a previous history of failure to respond to an adequate trial of risperidone. However, patients with known allergies or failure to respond to any of the other medications (aripiprazole, olanzapine, quetiapine or ziprasidone) will not receive that medication if they are randomized to the oral medication arm, but are not excluded from the study

Where it is running

• University of California, Los Angeles — Los Angeles, California, United States
• Medical College of Georgia, Department of Psychiatry — Augusta, Georgia, United States
• University of Iowa College of Medicine, Psychiatry Research — Iowa City, Iowa, United States
• Harvard Medical School -- Massachusetts General Hospital — Boston, Massachusetts, United States
• Harvard Medical School -- Dr. John C. Corrigan Community Mental Health Center — Fall River, Massachusetts, United States
• Creighton University — Omaha, Nebraska, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• The Zucker Hillside Hospital — Glen Oaks, New York, United States

Full record on ClinicalTrials.gov

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