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

This study is currently recruiting participants.
Verified December 2011 by Central South University
Sponsor:
Information provided by (Responsible Party):
xiaofeng Guo, Central South University
ClinicalTrials.gov Identifier:
NCT01490567
First received: November 9, 2011
Last updated: December 9, 2011
Last verified: December 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Donepezil Adjunctive Treatment for Cognitive Impairment in Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: Yes ]

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

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
Other Name: placebo
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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 The second xiangya hospital
  More Information

No publications provided

Responsible Party: xiaofeng Guo, Principal Investigator, Central South University
ClinicalTrials.gov Identifier: NCT01490567     History of Changes
Other Study ID Numbers: NSFC30900485, 201002003
Study First Received: November 9, 2011
Last Updated: December 9, 2011
Health Authority: China: National Natural Science Foundation

Keywords provided by Central South University:
Impaired Cognition Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Cognition Disorders
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013