Status:
COMPLETED
A Comparison of Long-acting Injectable Medications for Schizophrenia
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Duke University
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
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 haloper...
Detailed Description
The purpose of this comparative effectiveness research study is to learn more about different medications called antipsychotics that are used to treat schizophrenia or schizoaffective disorder. Specif...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
311 Patients enrolled
Trial Details
Trial ID
NCT01136772
Start Date
March 1 2011
End Date
July 1 2016
Last Update
October 21 2016
Active Locations (22)
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1
VA Palo Alto Heathcare Systems
Palo Alto, California, United States, 94304
2
Yale University/Connecticut Mental Health Center
New Haven, Connecticut, United States, 06519
3
University of Miami School of Medicine
Miami, Florida, United States, 33316
4
Medical College of Georgia
Augusta, Georgia, United States, 30912