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

C

Central South University

Status and phase

Unknown
Phase 4

Conditions

Schizophrenia
Impaired Cognition

Treatments

Drug: Donepezil
Drug: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01490567
201002003 (Other Grant/Funding Number)
NSFC30900485

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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;

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

80 participants in 2 patient groups, including a placebo group

placebo
Placebo Comparator group
Description:
Subjects will be given with a dose of 5mg/day placebo. All drugs will be administered orally.
Treatment:
Drug: placebo
donepezil
Active Comparator group
Description:
Subjects will be given with a dose of 5 mg/day donepezil. All drugs will be administered orally.
Treatment:
Drug: Donepezil

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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