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Identification and Treatment of the Liability to Develop Schizophrenia

Primary Purpose

Schizophrenia

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Risperidone
Sponsored by
Central South University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Schizophrenia focused on measuring Negative symptoms, neuropsychological deficits, Cognitive function, diagnostic, prevention

Eligibility Criteria

19 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Mental Health InstituteRecruiting

Outcomes

Primary Outcome Measures

Neuropsychological - cognitive measures

Secondary Outcome Measures

Psychiatric Symptoms

Full Information

First Posted
March 21, 2006
Last Updated
June 23, 2009
Sponsor
Central South University
Collaborators
Ortho-McNeil Janssen Scientific Affairs, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00305474
Brief Title
Identification and Treatment of the Liability to Develop Schizophrenia
Official Title
Identification and Treatment of the Liability to Develop Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
December 2003 (undefined)
Primary Completion Date
January 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Central South University
Collaborators
Ortho-McNeil Janssen Scientific Affairs, LLC

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Negative symptoms, neuropsychological deficits, Cognitive function, diagnostic, prevention

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Risperidone
Intervention Description
Risperidone will be given in low dosage to a random sample of family members of Schizophrenic patients
Primary Outcome Measure Information:
Title
Neuropsychological - cognitive measures
Time Frame
2003-2010
Secondary Outcome Measure Information:
Title
Psychiatric Symptoms
Time Frame
2003-2010

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lingjiang Li, MD, PhD
Phone
011-86-731-555-0413
Email
lilj9016@public.cs.hn.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Liwen Tan, MD, PhD
Phone
011-86-13874870034
Email
gangbie7788@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Stone, PhD
Organizational Affiliation
Harvard Medical School (HMS and HSDM)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lingjiang Li, MD, PhD
Organizational Affiliation
Central South Unversity
Official's Role
Study Chair
Facility Information:
Facility Name
Mental Health Institute
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liwen Tan, MD, PhD
Phone
01186-13874870034
Email
gangbie7788@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Liwen Tan, MD, PhD
First Name & Middle Initial & Last Name & Degree
Ning Ma, MD
First Name & Middle Initial & Last Name & Degree
You Yin, MD
First Name & Middle Initial & Last Name & Degree
Wenjuan Yu, MD
First Name & Middle Initial & Last Name & Degree
Feng Wan, MD
First Name & Middle Initial & Last Name & Degree
Yan Zhang, MD, MS

12. IPD Sharing Statement

Learn more about this trial

Identification and Treatment of the Liability to Develop Schizophrenia

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