Antidepressant and Antipsychotic to Treat Attenuated Positive and Negative Symptoms

NCT00169988 | Completed DMC

• 1 other identifier: 05-04-103
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Prodromal Schizophrenia; Psychotic Disorders

Keywords

clinical high risk; attenuated positive symptoms; attenuated negative symptoms; cognition; functional status; prodromal psychosis

Outcome Measures

Primary Outcomes (2)

• Score on attenuated positive symptom scale at 16 weeks

• Score on attenuated negative symptom scale at 16 weeks

Secondary Outcomes (3)

• Score on social functioning measure at 16 weeks

• Score on academic functioning measure at 16 weeks

• Score on cognitive measures at 16 weeks

Interventions

risperidone DRUG

sertraline-primary DRUG

Eligibility Criteria

• Age: 12 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead
• Stanley Medical Research Institute: collaborator
• Janssen Pharmaceutica N.V., Belgium: collaborator
• Pfizer: collaborator

Study Sites (1)

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

Glen Oaks, New York, 11004, United States

Location

MeSH Terms

Conditions

Schizotypal Personality Disorder; Psychotic Disorders

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Barbara A Cornblatt, PhD

  Long Island Jewish Medical Center (LIJMC)

  PRINCIPAL INVESTIGATOR

• Christoph U Correll, MD

  LIJMC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: March 1, 2004
• Study Completion: April 1, 2007
• Last Updated: December 17, 2009

Record last verified: 2007-10

Locations

US (1)