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
  Purpose

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 Intervention Phase
Schizophrenia
Drug: Risperidone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: Identification and Treatment of the Liability to Develop Schizophrenia

Resource links provided by NLM:


Further study details as provided by Central South University:

Primary Outcome Measures:
  • Neuropsychological - cognitive measures [ Time Frame: 2003-2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Psychiatric Symptoms [ Time Frame: 2003-2010 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2003
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Risperidone
    Risperidone will be given in low dosage to a random sample of family members of Schizophrenic patients
  Eligibility

Ages Eligible for Study:   19 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00305474

Contacts
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

Locations
China, Hunan
Mental Health Institute Recruiting
Changsha, Hunan, China, 410011
Contact: Liwen Tan, MD, PhD    01186-13874870034    gangbie7788@yahoo.com.cn   
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
Investigators
Principal Investigator: William Stone, PhD Harvard Medical School
Study Chair: Lingjiang Li, MD, PhD Central South Unversity
  More Information

No publications provided

Responsible Party: William Stone, PhD, Beth Israel- Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00305474     History of Changes
Other Study ID Numbers: XYMHI001
Study First Received: March 21, 2006
Last Updated: June 23, 2009
Health Authority: China: Ministry of Health

Keywords provided by Central South University:
Negative symptoms
neuropsychological deficits
Cognitive function
diagnostic
prevention

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Risperidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 29, 2014