Back to resultsA Double-blind, Placebo-controlled Trial of Donepezil Adjunctive Treatment for Cognitive Impairment in Schizophrenia
Primary Purpose
Impaired Cognition, Schizophrenia
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Donepezil
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Impaired Cognition focused on measuring Impaired Cognition Schizophrenia
Eligibility Criteria
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;
Sites / Locations
- the Second Xiangya Hospital of Central South UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
placebo
donepezil
Arm Description
Subjects will be given with a dose of 5mg/day placebo. All drugs will be administered orally.
Subjects will be given with a dose of 5 mg/day donepezil. All drugs will be administered orally.
Outcomes
Primary Outcome Measures
Mean Change From Baseline in the Composite Score From the Cognition Assessment Battery After 12 Weeks of Treatment
Secondary Outcome Measures
Mean Change From Baseline in Cognition Assessment scores After 12 Weeks of Treatment
Full Information
NCT ID
NCT01490567
First Posted
November 9, 2011
Last Updated
December 9, 2011
Sponsor
Central South University
1. Study Identification
Unique Protocol Identification Number
NCT01490567
Brief Title
A Double-blind, Placebo-controlled Trial of Donepezil Adjunctive Treatment for Cognitive Impairment in Schizophrenia
Official Title
Donepezil Adjunctive Treatment for Cognitive Impairment in Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
June 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central South University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Cognition, Schizophrenia
Keywords
Impaired Cognition Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will be given with a dose of 5mg/day placebo. All drugs will be administered orally.
Arm Title
donepezil
Arm Type
Active Comparator
Arm Description
Subjects will be given with a dose of 5 mg/day donepezil. All drugs will be administered orally.
Intervention Type
Drug
Intervention Name(s)
Donepezil
Other Intervention Name(s)
Donepezil hydrochloride
Intervention Description
5 mg/day
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo 5mg/d
Primary Outcome Measure Information:
Title
Mean Change From Baseline in the Composite Score From the Cognition Assessment Battery After 12 Weeks of Treatment
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in Cognition Assessment scores After 12 Weeks of Treatment
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaofeng Guo, doctor
Organizational Affiliation
Second Xiangya Hospital of Central South University
Official's Role
Principal Investigator
Facility Information:
Facility Name
the Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaofeng Guo, Doctor
Phone
86-731-85554052
Email
gxfd@sina.com.cn
12. IPD Sharing Statement
Learn more about this trial
A Double-blind, Placebo-controlled Trial of Donepezil Adjunctive Treatment for Cognitive Impairment in Schizophrenia
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