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Antidepressant and Antipsychotic to Treat Attenuated Positive and Negative Symptoms

This study has been completed.

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
  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

MedlinePlus related topics:   Antidepressants    Psychotic Disorders    Schizophrenia   

ChemIDplus related topics:   Sertraline hydrochloride    Sertraline    Risperidone   

U.S. FDA Resources

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

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


RAP Program Homepage  This link exits the ClinicalTrials.gov site
 

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

Keywords provided by North Shore Long Island Jewish Health System:
clinical high risk  
attenuated positive symptoms  
attenuated negative symptoms  
cognition
functional status
prodromal psychosis

Study placed in the following topic categories:
Schizophrenia
Dopamine
Mental Disorders
Risperidone
Schizotypal Personality Disorder
Sertraline
Psychotic Disorders
Serotonin
Schizophrenia and Disorders with Psychotic Features
Personality Disorders

Additional relevant MeSH terms:
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Antagonists
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on September 22, 2008




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