Impaired Cognition, Schizophrenia
Conditions
Keywords
Impaired Cognition Schizophrenia
Brief summary
The objective of the study was to study the effects of donepezil on cognition in patients with schizophrenia. The investigators conducted a 12-week, double-blind, placebo-controlled trial of donepezil as adjunctive treatment to antipsychotic drugs on patients with schizophrenia.
Detailed description
The investigators conducted a 12-week, double-blind, placebo-controlled trial of donepezil as adjunctive treatment to antipsychotic drugs on patients with schizophrenia.The trial will be complete in 2012.
Interventions
DRUGDonepezil
5 mg/day
DRUGplacebo
placebo 5mg/d
Sponsors
Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* DSM-IV diagnosis of schizophrenia as determined by the Structured Clinical Interview for DSM-IV Axis I Disorders-Clinician Version; * Between 18 and 40 years of age; * Duration of the illness must be longer than 2 year; * Patient's current antipsychotic medication regimen must be stable; * Must be in a stable living arrangement;
Exclusion criteria
* Patient has mental retardation or severe organic brain syndromes; * Treatment with Electroconvulsive Therapy (ECT) within 6 months prior to screening; * Has suicidal attempts or ideation or violent behavior within the last 12 months; * Patient has a history of alcohol/drug dependence;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Change From Baseline in the Composite Score From the Cognition Assessment Battery After 12 Weeks of Treatment | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Mean Change From Baseline in Cognition Assessment scores After 12 Weeks of Treatment | 12 weeks |
Countries
China
Outcome results
None listed