Identification and Treatment of the Liability to Develop Schizophrenia

NCT00305474 | Unknown Phase 4

• 1 other identifier: XYMHI001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Negative symptoms; neuropsychological deficits; Cognitive function; diagnostic; prevention

Outcome Measures

Primary Outcomes (1)

• Neuropsychological - cognitive measures

  2003-2010

Secondary Outcomes (1)

• Psychiatric Symptoms

  2003-2010

Interventions

Risperidone DRUG

Risperidone will be given in low dosage to a random sample of family members of Schizophrenic patients

Eligibility Criteria

• Age: 19 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central South University: lead
• Ortho-McNeil Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

Mental Health Institute

Changsha, Hunan, 410011, China

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Disease

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• William Stone, PhD

  Harvard Medical School (HMS and HSDM)

  PRINCIPAL INVESTIGATOR

• Lingjiang Li, MD, PhD

  Central South Unversity

  STUDY CHAIR

Central Study Contacts

Lingjiang Li, MD, PhD

CONTACT

011-86-731-555-0413; lilj9016@public.cs.hn.cn

Liwen Tan, MD, PhD

CONTACT

011-86-13874870034; gangbie7788@yahoo.com.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 21, 2006
• First Posted: March 22, 2006
• Study Start: December 1, 2003
• Primary Completion: January 1, 2010
• Last Updated: June 24, 2009

Record last verified: 2009-06

Locations

CN (1)