Donepezil Double Blind Trial for ECT Memory Disfunction

NCT ID: NCT00465283

Last Updated: 2009-01-27

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2010-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia Schizoaffective Disorder Schizophreniform Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Donepezil

Group Type ACTIVE_COMPARATOR

Donepezil

Intervention Type DRUG

Tab.Donepezil 5 mg once daily during ECT treatment and the month after the last ECT treatment

placebo

Group Type PLACEBO_COMPARATOR

Donepezil

Intervention Type DRUG

Tab.Donepezil 5 mg once daily during ECT treatment and the month after the last ECT treatment

Interventions

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Donepezil

Tab.Donepezil 5 mg once daily during ECT treatment and the month after the last ECT treatment

Intervention Type DRUG

Other Intervention Names

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Donepezil - Memorit

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BeerYaakov Mental Health Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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BeerYaakov Mental Health Center

Principal Investigators

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Tali Nachshoni, MD

Role: PRINCIPAL_INVESTIGATOR

Beer Yaakov Mental Health Center

Locations

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Beer Yaakov MHC

Beer Yaacov, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Tali Nachshoni, MD

Role: CONTACT

972-8-9258372

Marina Kupchik, MD

Role: CONTACT

972-89258382

Facility Contacts

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Tali Nachshoni, M.D.

Role: primary

972-8-9258372

Other Identifiers

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Donepezil-180CTIL

Identifier Type: -

Identifier Source: org_study_id

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