Identification and Treatment of the Liability to Develop Schizophrenia

Overview

This study seeks to determine whether adult, non-psychotic, first-degree relatives of schizophrenic patients who show specific neurocognitive deficits and negative symptoms will show improvements in these areas following a 6-month, double-blind trial of a low dose (up to 2.0 mg) of risperidone.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: January 2010

Interventions

  • Drug: Risperidone
    • Risperidone will be given in low dosage to a random sample of family members of Schizophrenic patients

Clinical Trial Outcome Measures

Primary Measures

  • Neuropsychological – cognitive measures
    • Time Frame: 2003-2010

Secondary Measures

  • Psychiatric Symptoms
    • Time Frame: 2003-2010

Participating in This Clinical Trial

Inclusion Criteria

  • Having at least one first-degree biological relative with schizophrenia and their age is between 19 and 59.
  • Desire to participate in a medication trial.
  • Is able to provide informed consent.
  • Having moderate levels of negative symptoms, defined as 6 items rated 3 or higher on the Scale for the Assessment of Negative Symptoms (SANS).
  • Scoring two or more standard deviations below normal in at least one of three cognitive domains: vigilance/working memory, long-term verbal memory, and executive functions.
  • Scoring at least one standard deviation below normal in a second cognitive domain.

Exclusion Criteria

  • IQ less than 80.
  • Formal education less than 10 years.
  • History of psychotic disorders.
  • History of treatment with an antipsychotic medication.
  • A substance abuse diagnosis within 6 months of diagnosis.
  • A head injury with documented loss of consciousness exceeding 5 minutes (or subsequent cognitive deficits).
  • A history of neurologic disease or damage.
  • A medical condition with significant cognitive sequelae.
  • A history of electroconvulsive treatment.

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 59 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Central South University
  • Collaborator
    • Ortho-McNeil Janssen Scientific Affairs, LLC
  • Provider of Information About this Clinical Study
    • William Stone, PhD, Beth Israel- Deaconess Medical Center
  • Overall Official(s)
    • William Stone, PhD, Principal Investigator, Harvard Medical School
    • Lingjiang Li, MD, PhD, Study Chair, Central South Unversity
  • Overall Contact(s)
    • Lingjiang Li, MD, PhD, 011-86-731-555-0413, lilj9016@public.cs.hn.cn

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