Antidepressant and Antipsychotic to Treat Attenuated Positive and Negative Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00169988
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : December 17, 2009
Stanley Medical Research Institute
Janssen Pharmaceutica N.V., Belgium
Information provided by:
Northwell Health

Brief Summary:
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 or disease Intervention/treatment Phase
Prodromal Schizophrenia Psychotic Disorders Drug: risperidone Drug: sertraline-primary Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Sertraline Alone vs. in Combination With Risperidone in the Treatment of Attenuated Positive and Negative Symptoms
Study Start Date : March 2004
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Score on attenuated positive symptom scale at 16 weeks
  2. Score on attenuated negative symptom scale at 16 weeks

Secondary Outcome Measures :
  1. Score on social functioning measure at 16 weeks
  2. Score on academic functioning measure at 16 weeks
  3. Score on cognitive measures at 16 weeks

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00169988

United States, New York
RAP Program, Dept. of Psychiatry Research, The Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004
Sponsors and Collaborators
Northwell Health
Stanley Medical Research Institute
Janssen Pharmaceutica N.V., Belgium
Principal Investigator: Barbara A Cornblatt, PhD Long Island Jewish Medical Center (LIJMC)
Study Director: Christoph U Correll, MD LIJMC

Additional Information: Identifier: NCT00169988     History of Changes
Other Study ID Numbers: 05-04-103
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: December 17, 2009
Last Verified: October 2007

Keywords provided by Northwell Health:
clinical high risk
attenuated positive symptoms
attenuated negative symptoms
functional status
prodromal psychosis

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizotypal Personality Disorder
Schizophrenia Spectrum and Other Psychotic Disorders
Personality Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antidepressive Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators