Status:
COMPLETED
Comparison of Aripiprazole and Risperidone for the Treatment of People With First-Episode Psychosis
Lead Sponsor:
Northwell Health
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Schizophrenia
Eligibility:
All Genders
15-40 years
Phase:
PHASE4
Brief Summary
This 52 week long study evaluates the effectiveness of aripiprazole versus risperidone in treating people with first-episode schizophrenia. Patients who do not improve with these medications receive c...
Detailed Description
Schizophrenia is a severely disabling brain disorder. People with schizophrenia often experience hallucinations, delusions, thought disorders, and movement disorders. Medications are available to alle...
Eligibility Criteria
Inclusion
- Current Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, or similar psychotic disorder not otherwise specified, as assessed using the Structured Clinical Interview for Axis I DSM-IV Disorders (SCID-I/P)
- History of previous antipsychotic medication treatment for a duration of 2 weeks or less
- Current positive symptoms rated 4 (moderate) or more on one or more of the following Brief Psychiatric Rating Scale (BPRS-A) items: conceptual disorganization; grandiosity; hallucinatory behavior; or unusual thought content
- Agrees to use an effective form of contraception
Exclusion
- Any serious neurological or endocrine disorder, or any medical condition or treatment known to affect the brain
- Any current medical condition that requires treatment with a medication with psychotropic effects
- At significant risk for suicidal or homicidal behavior
- Cognitive or language limitations, or any other factor that would interfere with a participant's ability to provide informed consent or safely participate in study procedures
- Diagnosis of diabetes, defined as a fasting plasma glucose level of at least 126 mg/dL, or metabolic syndrome, defined as three or more of the following: high blood pressure (greater than 135/85 mmHg); truncal obesity (having a waist circumference greater than 40 inches for men and greater than 35 inches for women); elevated fasting glucose (greater than 110 mg/dL); low HDL-cholesterol (less than 40 mg/dL for men and less than 50 mg/dL for women); or elevated triglycerides (defined as greater than 150 mg/dL)
- Requires treatment with an antidepressant or mood stabilizing medication
- Meets DSM-IV criteria for a current substance-induced psychotic disorder, a psychotic disorder due to a general medical condition, delusional disorder, brief psychotic disorder, shared psychotic disorder, or a mood disorder (major depression or bipolar) with psychotic features
- Any medical conditions that would make treatment with risperidone or aripiprazole medically inadvisable
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT00320671
Start Date
December 1 2005
End Date
December 1 2015
Last Update
September 8 2016
Active Locations (1)
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1
The Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004