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

Schizophrenia Clinical Trial

Official title:

Donepezil Adjunctive Treatment for Cognitive Impairment in Schizophrenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01490567
• Other study ID #: NSFC30900485
• Secondary ID: 201002003
• Status: Recruiting
• Phase: Phase 4
• First received: November 9, 2011
• Last updated: December 9, 2011
• Start date: June 2011
• Est. completion date: June 2012

Study information

• Verified date: December 2011
• Source: Central South University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Cognition Disorders
• Impaired Cognition
• Schizophrenia

Intervention

Drug:
• Donepezil
5 mg/day
• placebo
placebo 5mg/d

Locations

Country	Name	City	State
China	the Second Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in the Composite Score From the Cognition Assessment Battery After 12 Weeks of Treatment		12 weeks	Yes
Secondary	Mean Change From Baseline in Cognition Assessment scores After 12 Weeks of Treatment		12 weeks	Yes