Donepezil Double Blind Trial for ECT Memory Disfunction

January 26, 2009 updated by: BeerYaakov Mental Health Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Beer Yaacov, Israel, 70350

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Data will be analyzed using SPSS for Windows.
Time Frame: after 5 ECT treatments
after 5 ECT treatments
Results of the memory and neurocognitive measures will be examined
Time Frame: after 8 ECT treatments
after 8 ECT treatments
using repeated MANOVA with before, within and after ECT treatment.
Time Frame: 1 month after the last ECT treatment
1 month after the last ECT treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BeerYaakov Mental Health Center

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Anticipated)

January 1, 2010

Study Completion (Anticipated)

January 1, 2010

Study Registration Dates

First Submitted

April 22, 2007

First Submitted That Met QC Criteria

April 22, 2007

First Posted (Estimate)

April 24, 2007

Study Record Updates

Last Update Posted (Estimate)

January 27, 2009

Last Update Submitted That Met QC Criteria

January 26, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Donepezil-180CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Schizophrenia

Clinical Trials on Donepezil

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe