Donepezil Double Blind Trial for ECT Memory Disfunction

Schizophrenia Clinical Trial

Official title:

Donepezil Double Blind Trial for ECT Memory Disfunction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00465283
• Other study ID #: Donepezil-180CTIL
• Status: Recruiting
• Phase: Phase 4
• First received: April 22, 2007
• Last updated: January 26, 2009
• Start date: May 2007
• Est. completion date: January 2010

Study information

• Verified date: January 2009
• Source: BeerYaakov Mental Health Center
• Contact: Tali Nachshoni, MD
• Phone: 972-8-9258372
• Email: bynachshoni[@]beer-ness.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Schizophreniform Disorder

Intervention

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

Locations

Country	Name	City	State
Israel	Beer Yaakov MHC	Beer Yaacov

Sponsors (1)

Lead Sponsor	Collaborator
BeerYaakov Mental Health Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Data will be analyzed using SPSS for Windows.		after 5 ECT treatments	No
Primary	Results of the memory and neurocognitive measures will be examined		after 8 ECT treatments	No
Primary	using repeated MANOVA with before, within and after ECT treatment.		1 month after the last ECT treatment	No