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

December 9, 2011 updated by: xiaofeng Guo, Central South University

Donepezil Adjunctive Treatment for Cognitive Impairment in Schizophrenia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410011
        • Recruiting
        • The second Xiangya Hospital of Central South University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Subjects will be given with a dose of 5mg/day placebo. All drugs will be administered orally.
Drug: placebo
placebo 5mg/d
Active Comparator: donepezil
Subjects will be given with a dose of 5 mg/day donepezil. All drugs will be administered orally.
Drug: Donepezil
5 mg/day
Other Names:
  • Donepezil hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Change From Baseline in the Composite Score From the Cognition Assessment Battery After 12 Weeks of Treatment
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean Change From Baseline in Cognition Assessment scores After 12 Weeks of Treatment
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central South University

Investigators

  • Principal Investigator: Xiaofeng Guo, doctor, Second Xiangya Hospital of Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Anticipated)

June 1, 2012

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

November 9, 2011

First Submitted That Met QC Criteria

December 9, 2011

First Posted (Estimate)

December 13, 2011

Study Record Updates

Last Update Posted (Estimate)

December 13, 2011

Last Update Submitted That Met QC Criteria

December 9, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSFC30900485
  • 201002003 (Other Grant/Funding Number: the R&D Special Fund for Health Profession in China)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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