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

NCT ID: NCT01490567

Last Updated: 2011-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-06-30

Brief Summary

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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

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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.

Conditions

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Impaired Cognition Schizophrenia

Keywords

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Impaired Cognition Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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placebo

Subjects will be given with a dose of 5mg/day placebo. All drugs will be administered orally.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo 5mg/d

donepezil

Subjects will be given with a dose of 5 mg/day donepezil. All drugs will be administered orally.

Group Type ACTIVE_COMPARATOR

Donepezil

Intervention Type DRUG

5 mg/day

Interventions

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Donepezil

5 mg/day

Intervention Type DRUG

placebo

placebo 5mg/d

Intervention Type DRUG

Other Intervention Names

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Donepezil hydrochloride

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central South University

OTHER

Sponsor Role lead

Responsible Party

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xiaofeng Guo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaofeng Guo, doctor

Role: PRINCIPAL_INVESTIGATOR

Second Xiangya Hospital of Central South University

Locations

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the Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Xiaofeng Guo, Doctor

Role: primary

Other Identifiers

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201002003

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NSFC30900485

Identifier Type: -

Identifier Source: org_study_id