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Identification and Treatment of the Liability to Develop Schizophrenia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Central South University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by:
Central South University
ClinicalTrials.gov Identifier:
NCT00305474
First received: March 21, 2006
Last updated: June 23, 2009
Last verified: June 2009
History of Changes

March 21, 2006
June 23, 2009
December 2003
January 2010   (final data collection date for primary outcome measure)
Neuropsychological - cognitive measures [ Time Frame: 2003-2010 ] [ Designated as safety issue: No ]
Cognitive function
Complete list of historical versions of study NCT00305474 on ClinicalTrials.gov Archive Site
Psychiatric Symptoms [ Time Frame: 2003-2010 ] [ Designated as safety issue: No ]
Negative Symptoms
Not Provided
Not Provided
 
Identification and Treatment of the Liability to Develop Schizophrenia
Identification and Treatment of the Liability to Develop Schizophrenia

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Schizophrenia
Drug: Risperidone
Risperidone will be given in low dosage to a random sample of family members of Schizophrenic patients
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Not Provided
January 2010   (final data collection date for primary outcome measure)

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.
Both
19 Years to 59 Years
Yes
Contact: Lingjiang Li, MD, PhD 011-86-731-555-0413 lilj9016@public.cs.hn.cn
Contact: Liwen Tan, MD, PhD 011-86-13874870034 gangbie7788@yahoo.com.cn
China
 
NCT00305474
XYMHI001
Not Provided
William Stone, PhD, Beth Israel- Deaconess Medical Center
Central South University
Ortho-McNeil Janssen Scientific Affairs, LLC
Principal Investigator: William Stone, PhD Harvard Medical School
Study Chair: Lingjiang Li, MD, PhD Central South Unversity
Central South University
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP