Antidepressant and Antipsychotic to Treat Attenuated Positive and Negative Symptoms
This study has been completed.
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
First received: September 9, 2005
Last updated: December 16, 2009
Last verified: October 2007
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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
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 |
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:
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 June 18, 2013