Antidepressant and Antipsychotic to Treat Attenuated Positive and Negative Symptoms

NCT00169988

Last updated date
Study Location
RAP Program, Dept. of Psychiatry Research, The Zucker Hillside Hospital
Glen Oaks, New York, 11004, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Prodromal Schizophrenia, Psychotic Disorders
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12-22 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Prodromal Schizophrenia, Psychotic DisordersAntidepressant and Antipsychotic to Treat Attenuated Positive and Negative Symptoms
NCT00169988
  1. Glen Oaks, New York
ALL GENDERS
12 Years+
years
MULTIPLE SITES
Advanced Information
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, PhDLong Island Jewish Medical Center (LIJMC)
Study Director:Christoph U Correll, MDLIJMC
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