Identification and Treatment of the Liability to Develop Schizophrenia

Schizophrenia Clinical Trial

Official title:

Identification and Treatment of the Liability to Develop Schizophrenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00305474
• Other study ID #: XYMHI001
• Status: Recruiting
• Phase: Phase 4
• First received: March 21, 2006
• Last updated: June 23, 2009
• Start date: December 2003

Study information

• Verified date: June 2009
• Source: Central South University
• Contact: Lingjiang Li, MD, PhD
• Phone: 011-86-731-555-0413
• Email: lilj9016[@]public.cs.hn.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 59 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
China	Mental Health Institute	Changsha	Hunan

Sponsors (2)

Lead Sponsor	Collaborator
Central South University	Ortho-McNeil Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuropsychological - cognitive measures		2003-2010	No
Secondary	Psychiatric Symptoms		2003-2010	No