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

NCT01490567 | Unknown Phase 4 DMC

• 2 other identifiers: NSFC30900485201002003
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Impaired Cognition; Schizophrenia

Keywords

Impaired Cognition Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in the Composite Score From the Cognition Assessment Battery After 12 Weeks of Treatment

  12 weeks

Secondary Outcomes (1)

• Mean Change From Baseline in Cognition Assessment scores After 12 Weeks of Treatment

  12 weeks

Study Arms (2)

placebo

PLACEBO COMPARATOR

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

Drug: placebo

donepezil

ACTIVE COMPARATOR

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

Drug: Donepezil

Interventions

Donepezil DRUG

5 mg/day

Also known as: Donepezil hydrochloride

donepezil

placebo DRUG

placebo 5mg/d

placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

the Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

RECRUITING

MeSH Terms

Conditions

Cognition Disorders; Schizophrenia

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Xiaofeng Guo, doctor

  Second Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 9, 2011
• First Posted: December 13, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: December 13, 2011

Record last verified: 2011-12

Locations

CN (1)