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Trial record 1 of 1 for:    NCT00169988
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Antidepressant and Antipsychotic to Treat Attenuated Positive and Negative Symptoms

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ClinicalTrials.gov Identifier: NCT00169988
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : December 17, 2009
Sponsor:
Collaborators:
Stanley Medical Research Institute
Janssen Pharmaceutica N.V., Belgium
Pfizer
Information provided by:
Northwell Health

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 15, 2005
Last Update Posted Date December 17, 2009
Study Start Date  ICMJE March 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
  • Score on attenuated positive symptom scale at 16 weeks
  • Score on attenuated negative symptom scale at 16 weeks
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
  • Score on social functioning measure at 16 weeks
  • Score on academic functioning measure at 16 weeks
  • Score on cognitive measures at 16 weeks
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antidepressant and Antipsychotic to Treat Attenuated Positive and Negative Symptoms
Official Title  ICMJE Sertraline Alone vs. in Combination With Risperidone in the Treatment of Attenuated Positive and Negative Symptoms
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Prodromal Schizophrenia
  • Psychotic Disorders
Intervention  ICMJE
  • Drug: risperidone
  • Drug: sertraline-primary
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 17, 2007)
8
Original Enrollment  ICMJE
 (submitted: September 9, 2005)
60
Actual Study Completion Date  ICMJE April 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 22 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00169988
Other Study ID Numbers  ICMJE 05-04-103
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Northwell Health
Collaborators  ICMJE
  • Stanley Medical Research Institute
  • Janssen Pharmaceutica N.V., Belgium
  • Pfizer
Investigators  ICMJE
Principal Investigator: Barbara A Cornblatt, PhD Long Island Jewish Medical Center (LIJMC)
Study Director: Christoph U Correll, MD LIJMC
PRS Account Northwell Health
Verification Date October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP