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Identification and Treatment of the Liability to Develop Schizophrenia

C

Central South University

Status and phase

Unknown
Phase 4

Conditions

Schizophrenia

Treatments

Drug: Risperidone

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00305474
XYMHI001

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

19 to 59 years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Central trial contact

Liwen Tan, MD, PhD; Lingjiang Li, MD, PhD

Data sourced from clinicaltrials.gov

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