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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by xiaofeng Guo, Central South University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01490567
First Posted: December 13, 2011
Last Update Posted: December 13, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
xiaofeng Guo, Central South University
  Purpose
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.

Condition Intervention Phase
Impaired Cognition Schizophrenia Drug: Donepezil Drug: placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Donepezil Adjunctive Treatment for Cognitive Impairment in Schizophrenia

Resource links provided by NLM:


Further study details as provided by xiaofeng Guo, Central South University:

Primary Outcome Measures:
  • Mean Change From Baseline in the Composite Score From the Cognition Assessment Battery After 12 Weeks of Treatment [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Mean Change From Baseline in Cognition Assessment scores After 12 Weeks of Treatment [ Time Frame: 12 weeks ]

Estimated Enrollment: 80
Study Start Date: June 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Donepezil hydrochloride

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01490567


Locations
China, Hunan
the Second Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China, 410011
Contact: Xiaofeng Guo, Doctor    86-731-85554052    gxfd@sina.com.cn   
Sponsors and Collaborators
Central South University
Investigators
Principal Investigator: Xiaofeng Guo, doctor Second Xiangya Hospital of Central South University
  More Information

Responsible Party: xiaofeng Guo, Principal Investigator, Central South University
ClinicalTrials.gov Identifier: NCT01490567     History of Changes
Other Study ID Numbers: NSFC30900485
201002003 ( Other Grant/Funding Number: the R&D Special Fund for Health Profession in China )
First Submitted: November 9, 2011
First Posted: December 13, 2011
Last Update Posted: December 13, 2011
Last Verified: December 2011

Keywords provided by xiaofeng Guo, Central South University:
Impaired Cognition Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Cognitive Dysfunction
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Cognition Disorders
Neurocognitive Disorders
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents