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| Name | Class |
|---|---|
| Stanley Medical Research Institute | OTHER |
| Janssen Pharmaceutica N.V., Belgium | INDUSTRY |
| Pfizer | INDUSTRY |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| risperidone | Drug | |||
| sertraline-primary | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Score on attenuated positive symptom scale at 16 weeks | ||
| Score on attenuated negative symptom scale at 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Score on social functioning measure at 16 weeks | ||
| Score on academic functioning measure at 16 weeks | ||
| Score on cognitive measures at 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara A Cornblatt, PhD | Long Island Jewish Medical Center (LIJMC) | Principal Investigator |
| Christoph U Correll, MD | LIJMC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RAP Program, Dept. of Psychiatry Research, The Zucker Hillside Hospital | Glen Oaks | New York | 11004 | United States |
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| ID | Term |
|---|---|
| D012569 | Schizotypal Personality Disorder |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D010554 | Personality Disorders |
| D001523 | Mental Disorders |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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| ID | Term |
|---|---|
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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