A Double-blind, Placebo-controlled Trial of Donepezil Adjunctive Treatment for Cognitive Impairment in Schizophrenia

Phase 4

• Conditions: Impaired Cognition; Schizophrenia
• Interventions: Drug: placebo; Drug: Donepezil

• Registration Number: NCT01490567
• Lead Sponsor: Central South University

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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-11-09
• Status Verified: 2011-12
• Study First Submitted QC: 2011-12-09
• Last Update Submitted: 2011-12-09
• Study First Posted: 2011-12-13
• Last Update Posted: 2011-12-13
• Primary Completion: 2012-06
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	Subjects will be given with a dose of 5mg/day placebo. All drugs will be administered orally.
donepezil	Donepezil	Subjects will be given with a dose of 5 mg/day donepezil. All drugs will be administered orally.

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in the Composite Score From the Cognition Assessment Battery After 12 Weeks of Treatment	12 weeks

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Cognition Assessment scores After 12 Weeks of Treatment	12 weeks

Trial Locations

Locations (1)

the Second Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China