Back to results

Donepezil Double Blind Trial for ECT Memory Disfunction

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder

Status

Unknown status

Phase

Phase 4

Locations

Israel

Study Type

Interventional

Intervention

Donepezil

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Donepezil, ECT, Memory Disfunction

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Beer Yaakov MHCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Donepezil

placebo

Arm Description

Outcomes

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00465283

First Posted

April 22, 2007

Last Updated

January 26, 2009

Sponsor

BeerYaakov Mental Health Center

1. Study Identification

Unique Protocol Identification Number

NCT00465283

Brief Title

Donepezil Double Blind Trial for ECT Memory Disfunction

Official Title

Donepezil Double Blind Trial for ECT Memory Disfunction

Study Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Unknown status

Study Start Date

May 2007 (undefined)

Primary Completion Date

January 2010 (Anticipated)

Study Completion Date

January 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

BeerYaakov Mental Health Center

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder

Keywords

Donepezil, ECT, Memory Disfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Donepezil

Arm Type

Active Comparator

Arm Title

placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Donepezil

Other Intervention Name(s)

Donepezil - Memorit

Intervention Description

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

Primary Outcome Measure Information:

Title

Data will be analyzed using SPSS for Windows.

Time Frame

after 5 ECT treatments

Title

Results of the memory and neurocognitive measures will be examined

Time Frame

after 8 ECT treatments

Title

using repeated MANOVA with before, within and after ECT treatment.

Time Frame

1 month after the last ECT treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tali Nachshoni, MD

Phone

972-8-9258372

bynachshoni@beer-ness.health.gov.il

First Name & Middle Initial & Last Name or Official Title & Degree

Marina Kupchik, MD

Phone

972-89258382

kupchik@beer-ness.health.gov.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tali Nachshoni, MD

Organizational Affiliation

Beer Yaakov Mental Health Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beer Yaakov MHC

City

Beer Yaacov

ZIP/Postal Code

70350

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tali Nachshoni, M.D.

Phone

972-8-9258372

bynachshoni@beer-ness.health.gov.il

First Name & Middle Initial & Last Name & Degree

Tali Nachshoni, MD

12. IPD Sharing Statement

Learn more about this trial

Donepezil Double Blind Trial for ECT Memory Disfunction

We'll reach out to this number within 24 hrs