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Identification and Treatment of the Liability to Develop Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00305474
Recruitment Status : Unknown
Verified June 2009 by Central South University.
Recruitment status was:  Recruiting
First Posted : March 22, 2006
Last Update Posted : June 24, 2009
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by:
Central South University

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 these areas following a 6-month, double-blind trial of a low dose (up to 2.0 mg) of risperidone.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Risperidone Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Identification and Treatment of the Liability to Develop Schizophrenia
Study Start Date : December 2003
Estimated Primary Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone

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

Primary Outcome Measures :
  1. Neuropsychological - cognitive measures [ Time Frame: 2003-2010 ]

Secondary Outcome Measures :
  1. Psychiatric Symptoms [ Time Frame: 2003-2010 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00305474

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Contact: Lingjiang Li, MD, PhD 011-86-731-555-0413
Contact: Liwen Tan, MD, PhD 011-86-13874870034

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China, Hunan
Mental Health Institute Recruiting
Changsha, Hunan, China, 410011
Contact: Liwen Tan, MD, PhD    01186-13874870034   
Principal Investigator: Liwen Tan, MD, PhD         
Sub-Investigator: Ning Ma, MD         
Sub-Investigator: You Yin, MD         
Sub-Investigator: Wenjuan Yu, MD         
Sub-Investigator: Feng Wan, MD         
Sub-Investigator: Yan Zhang, MD, MS         
Sponsors and Collaborators
Central South University
Ortho-McNeil Janssen Scientific Affairs, LLC
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Principal Investigator: William Stone, PhD Harvard Medical School
Study Chair: Lingjiang Li, MD, PhD Central South Unversity

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Responsible Party: William Stone, PhD, Beth Israel- Deaconess Medical Center Identifier: NCT00305474    
Other Study ID Numbers: XYMHI001
First Posted: March 22, 2006    Key Record Dates
Last Update Posted: June 24, 2009
Last Verified: June 2009
Keywords provided by Central South University:
Negative symptoms
neuropsychological deficits
Cognitive function
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents