Antidepressant and Antipsychotic to Treat Attenuated Positive and Negative Symptoms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2007-04-30

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.

Conditions

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Prodromal Schizophrenia Psychotic Disorders

Keywords

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clinical high risk attenuated positive symptoms attenuated negative symptoms cognition functional status prodromal psychosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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risperidone

Intervention Type DRUG

sertraline-primary

Intervention Type DRUG

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

Minimum Eligible Age

12 Years

Maximum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Barbara A Cornblatt, PhD

Role: PRINCIPAL_INVESTIGATOR

Long Island Jewish Medical Center (LIJMC)

Christoph U Correll, MD

Role: STUDY_DIRECTOR

LIJMC

Locations

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RAP Program, Dept. of Psychiatry Research, The Zucker Hillside Hospital

Glen Oaks, New York, United States

Site Status

Countries

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United States

Other Identifiers

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05-04-103

Identifier Type: -

Identifier Source: org_study_id