Donepezil Double Blind Trial for ECT Memory Disfunction

This study is not yet open for participant recruitment.

Verified by BeerYaakov Mental Health Center, April 2007

Sponsored by:	BeerYaakov Mental Health Center
Information provided by:	BeerYaakov Mental Health Center
ClinicalTrials.gov Identifier:	NCT00465283

Purpose

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	Intervention	Phase
Schizophrenia Schizoaffective Disorder Schizophreniform Disorder	Drug: Donezepil	Phase IV

MedlinePlus related topics: Memory Schizophrenia

Drug Information available for: Donepezil E 2020

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Donepezil Double Blind Trial for ECT Memory Disfunction

Further study details as provided by BeerYaakov Mental Health Center:

Primary Outcome Measures:

Data will be analyzed using SPSS for Windows.
Results of the memory and neurocognitive measures will be examined
using repeated MANOVA with before, within and after ECT treatment.

Estimated Enrollment:	40
Study Start Date:	May 2007

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00465283

Contacts

Contact: Tali Nachshoni, MD	972-8-9258372	bynachshoni@beer-ness.health.gov.il
Contact: Marina Kupchik, MD	972-89258382	kupchik@beer-ness.health.gov.il

Locations

Israel
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

More Information

Study ID Numbers:	Donepezil-180CTIL
Study First Received:	April 22, 2007
Last Updated:	April 22, 2007
ClinicalTrials.gov Identifier:	NCT00465283
Health Authority:	Israel: Ministry of Health

Keywords provided by BeerYaakov Mental Health Center:

Donepezil, ECT, Memory Disfunction

Study placed in the following topic categories:

Schizophrenia
Signs and Symptoms
Mental Disorders
Donepezil
Neurologic Manifestations

Psychotic Disorders
Neurobehavioral Manifestations
Memory Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Nootropic Agents
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Enzyme Inhibitors

Cholinergic Agents
Pharmacologic Actions
Cholinesterase Inhibitors
Pathologic Processes
Therapeutic Uses
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009