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OpenTrials
Completed

NCT Number: NCT00169988

Antidepressant and Antipsychotic to Treat Attenuated Positive and Negative Symptoms

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.

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Key information

Conditions

Prodromal Schizophrenia Mental Disorders Personality Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Schizotypal Personality Disorder

Age range

12 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RAP Program, Dept. of Psychiatry Research, The Zucker Hillside Hospital

Glen Oaks, New York, 11004, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Risperidone

Drug

sertraline-primary

Drug

Primary outcomes

  1. Score on attenuated positive symptom scale at 16 weeks

  2. Score on attenuated negative symptom scale at 16 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • Janssen Pharmaceutica N.V., Belgium
  • Pfizer
  • Stanley Medical Research Institute

Registry information

Official study title

Sertraline Alone vs. in Combination With Risperidone in the Treatment of Attenuated Positive and Negative Symptoms

Important dates

Study start
2004
Study completion
2007
First posted
Sep 15, 2005
Registry last updated
Dec 17, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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