Status:

UNKNOWN

Identification and Treatment of the Liability to Develop Schizophrenia

Lead Sponsor:

Central South University

Collaborating Sponsors:

Ortho-McNeil Janssen Scientific Affairs, LLC

Conditions:

Schizophrenia

Eligibility:

All Genders

19-59 years

Phase:

PHASE4

Brief Summary

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 t...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

December 1 2003

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT00305474

Start Date

December 1 2003

Last Update

June 24 2009

Active Locations (1)

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1

Mental Health Institute

Changsha, Hunan, China, 410011