Status:
COMPLETED
Preventing Relapse in Schizophrenia: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy
Lead Sponsor:
Northwell Health
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
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 bette...
Detailed Description
As is the case with many chronic illnesses, it can be challenging for people with schizophrenia to take multiple pills every day on a long-term basis. At the same time, missing or discontinuing the an...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
357 Patients enrolled
Trial Details
Trial ID
NCT00330863
Start Date
May 1 2006
End Date
January 1 2011
Last Update
July 10 2018
Active Locations (8)
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1
University of California, Los Angeles
Los Angeles, California, United States, 91344
2
Medical College of Georgia, Department of Psychiatry
Augusta, Georgia, United States, 30912-3800
3
University of Iowa College of Medicine, Psychiatry Research
Iowa City, Iowa, United States, 52242
4
Harvard Medical School -- Massachusetts General Hospital
Boston, Massachusetts, United States, 02114