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Sponsors and Collaborators: |
North Shore Long Island Jewish Health System Stanley Medical Research Institute Janssen Pharmaceutica N.V., Belgium Pfizer |
Information provided by: | North Shore Long Island Jewish Health System |
ClinicalTrials.gov Identifier: | NCT00169988 |
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 evaluate their ability to reduce unusual thoughts, suspiciousness and other unusual experiences, to improve reasoning ability, memory, attention and social skills in adolescents.
Condition | Intervention |
Prodromal Schizophrenia Psychotic Disorders |
Drug: risperidone Drug: sertraline-primary |
MedlinePlus related topics: | Antidepressants Psychotic Disorders Schizophrenia |
ChemIDplus related topics: | Sertraline hydrochloride Sertraline Risperidone |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Sertraline Alone vs. in Combination With Risperidone in the Treatment of Attenuated Positive and Negative Symptoms |
Enrollment: | 8 |
Study Start Date: | March 2004 |
Study Completion Date: | April 2007 |
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. At the initial appointment, all patients are assigned to sertraline and are randomly assigned to an adjunctive risperidone or placebo group. The treating physician is also blind to the medication assignment, which allows both the doctor and the patient to assess side effects and symptom improvement, unbiased by expectation. All patients receive an active medication.
Ages Eligible for Study: | 12 Years to 22 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |||||
RAP Program, Dept. of Psychiatry Research, The Zucker Hillside Hospital | |||||
Glen Oaks, New York, United States, 11004 |
North Shore Long Island Jewish Health System |
Stanley Medical Research Institute |
Janssen Pharmaceutica N.V., Belgium |
Pfizer |
Principal Investigator: | Barbara A Cornblatt, PhD | Long Island Jewish Medical Center (LIJMC) |
Study Director: | Christoph U Correll, MD | LIJMC |
RAP Program Homepage 
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Study ID Numbers: | 05-04-103 |
First Received: | September 9, 2005 |
Last Updated: | October 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00169988 |
Health Authority: | United States: Institutional Review Board |
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