Status:
COMPLETED
Antidepressant and Antipsychotic to Treat Attenuated Positive and Negative Symptoms
Lead Sponsor:
Northwell Health
Collaborating Sponsors:
Stanley Medical Research Institute
Janssen Pharmaceutica N.V., Belgium
Conditions:
Prodromal Schizophrenia
Psychotic Disorders
Eligibility:
All Genders
12-22 years
Phase:
NA
Brief Summary
The Recognition and Prevention (RAP) Program is conducting a research study comparing an antidepressant, sertraline, alone versus in combination with a second-generation antipsychotic, risperidone, to...
Detailed Description
Eligible patients are enrolled in a 16-week trial consisting of symptom and side effects ratings (10 visits), monthly blood and urine tests, and neuropsychological testing at the first and last visits...
Eligibility Criteria
Inclusion
- Participants are between the ages of 12 and 22.
- Participants are English-speaking.
- Participants are experiencing one or more symptoms like unusual thoughts, suspiciousness, or unusual perceptual experiences.
- Participants meet additional RAP criteria (evaluated during screening and interview).
Exclusion
- Participants have been diagnosed with an Axis I psychotic disorder, including: schizophreniform disorder, schizophrenia, schizoaffective disorder, bipolar disorder, or major depression with psychotic features.
- Participants have a history of neurological, neuroendocrine, or other medical conditions known to affect the brain.
- Participants have a medical condition that contraindicates treatment with sertraline or risperidone.
- Participants have past or current substance dependence.
- Participants are currently taking and responding well to antidepressant or antipsychotic medication
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00169988
Start Date
March 1 2004
End Date
April 1 2007
Last Update
December 17 2009
Active Locations (1)
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1
RAP Program, Dept. of Psychiatry Research, The Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004