Antidepressant and Antipsychotic to Treat Attenuated Positive and Negative Symptoms

This study has been completed.

First Received on September 9, 2005. Last Updated on December 16, 2009 History of Changes

Sponsor:	North Shore Long Island Jewish Health System
Collaborators:	Stanley Medical Research Institute Janssen Pharmaceutica N.V., Belgium Pfizer
Information provided by:	North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:	NCT00169988

Purpose

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Diagnostic
Official Title:	Sertraline Alone vs. in Combination With Risperidone in the Treatment of Attenuated Positive and Negative Symptoms

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Child Mental Health Mental Disorders Psychotic Disorders Schizophrenia

Drug Information available for: Sertraline hydrochloride Sertraline Risperidone

U.S. FDA Resources

Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:

Score on attenuated positive symptom scale at 16 weeks
Score on attenuated negative symptom scale at 16 weeks

Secondary Outcome Measures:

Score on social functioning measure at 16 weeks
Score on academic functioning measure at 16 weeks
Score on cognitive measures at 16 weeks

Enrollment:	8
Study Start Date:	March 2004
Study Completion Date:	April 2007

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. 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.

Eligibility

Ages Eligible for Study:	12 Years to 22 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169988

Locations

United States, New York
RAP Program, Dept. of Psychiatry Research, The Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004

Sponsors and Collaborators

North Shore Long Island Jewish Health System

Stanley Medical Research Institute

Janssen Pharmaceutica N.V., Belgium

Pfizer

Investigators

Principal Investigator:	Barbara A Cornblatt, PhD	Long Island Jewish Medical Center (LIJMC)
Study Director:	Christoph U Correll, MD	LIJMC

More Information

Additional Information:

RAP Program Homepage This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00169988 History of Changes
Other Study ID Numbers:	05-04-103
Study First Received:	September 9, 2005
Last Updated:	December 16, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:

clinical high risk
attenuated positive symptoms
attenuated negative symptoms

cognition
functional status
prodromal psychosis

Additional relevant MeSH terms:

Schizotypal Personality Disorder
Psychotic Disorders
Mental Disorders
Schizophrenia
Personality Disorders
Schizophrenia and Disorders with Psychotic Features
Antidepressive Agents
Sertraline
Risperidone
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Dopamine Antagonists
Dopamine Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012