Antidepressant and Antipsychotic to Treat Attenuated Positive and Negative Symptoms

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Sertraline Alone vs. in Combination With Risperidone in the Treatment of Attenuated Positive and Negative Symptoms

Conditions
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Prodromal Schizophrenia, Psychotic Disorders

Intervention / Treatment
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* Drug: risperidone
* Drug: sertraline-primary


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: risperidone|nan|
|Drug: sertraline-primary|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on attenuated positive symptom scale at 16 weeks |  |  | 
| Score on attenuated negative symptom scale at 16 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clinical high risk, attenuated positive symptoms, attenuated negative symptoms, cognition, functional status, prodromal psychosis