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Donepezil Double Blind Trial for ECT Memory Disfunction

Sponsor
BeerYaakov Mental Health Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT00465283
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
32.1
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a double blind randomized investigation of donepezil for patients suffering from schizophrenia, undergoing ECT.

Patients will be randomized to receive either donezepil or plasebo, in order to gauge whether donezepil has a protective effect on memory disfunction, while patients are treated with ECT. Several parameters will be invistigated at baseline: general psychopathological measures, memory function scales, side effects scales. The same measurements will be taken throughout the trial and one month after ending the ECT.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Donepezil Double Blind Trial for ECT Memory Disfunction
Study Start Date :
May 1, 2007
Anticipated Primary Completion Date :
Jan 1, 2010
Anticipated Study Completion Date :
Jan 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Donepezil

Drug: Donepezil
Tab.Donepezil 5 mg once daily during ECT treatment and the month after the last ECT treatment
Other Names:
  • Donepezil - Memorit

    		•
    Placebo Comparator: placebo

    Drug: Donepezil
    Tab.Donepezil 5 mg once daily during ECT treatment and the month after the last ECT treatment
    Other Names:
  • Donepezil - Memorit

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Data will be analyzed using SPSS for Windows. [after 5 ECT treatments]

    2. Results of the memory and neurocognitive measures will be examined [after 8 ECT treatments]

    3. using repeated MANOVA with before, within and after ECT treatment. [1 month after the last ECT treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Schizophrenia, Schizoaffective disorder, schizophreniform disorder patients who meet criteria for diagnoses by DSM-IV criteria and evaluated by the Structured Clinical Interview for DSM-IV (SCID)
    Exclusion Criteria:

    • History of serious neurological disorders including neurodegenerative deseases, mental retardation, substance and/or alcohol dependence.

    • Pregnant women

    • Patients who recieved ECT within 6 month

    • Patients whith contraindication to Donepezil treatment.

    • Patients with Lithium treatment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beer Yaakov MHC Beer Yaacov Israel 70350

    Sponsors and Collaborators

    • BeerYaakov Mental Health Center

    Investigators

    • Principal Investigator: Tali Nachshoni, MD, Beer Yaakov Mental Health Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00465283
    Other Study ID Numbers:
    • Donepezil-180CTIL
    First Posted:
    Apr 24, 2007
    Last Update Posted:
    Jan 27, 2009
    Last Verified:
    Jan 1, 2009
    Keywords provided by , ,
    Donepezil, ECT, Memory Disfunction
    Additional relevant MeSH terms:
    Disease
    Schizophrenia
    Psychotic Disorders
    Donepezil

    Study Results

    No Results Posted as of Jan 27, 2009