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Trial record 41 of 331 for:    DONEPEZIL

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

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ClinicalTrials.gov Identifier: NCT01490567
Recruitment Status : Unknown
Verified December 2011 by xiaofeng Guo, Central South University.
Recruitment status was:  Recruiting
First Posted : December 13, 2011
Last Update Posted : December 13, 2011
Sponsor:
Information provided by (Responsible Party):
xiaofeng Guo, 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.

Condition or disease Intervention/treatment Phase
Impaired Cognition Schizophrenia Drug: Donepezil Drug: placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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
Study Start Date : June 2011
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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 Name: Donepezil hydrochloride




Primary Outcome Measures :
  1. 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 :
  1. Mean Change From Baseline in Cognition Assessment scores After 12 Weeks of Treatment [ Time Frame: 12 weeks ]


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;

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

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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 Posted: December 13, 2011    Key Record Dates
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:
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Donepezil
Schizophrenia
Cognitive Dysfunction
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Cognition Disorders
Neurocognitive Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents