Donepezil Double Blind Trial for ECT Memory Disfunction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by BeerYaakov Mental Health Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
BeerYaakov Mental Health Center
ClinicalTrials.gov Identifier:
NCT00465283
First received: April 22, 2007
Last updated: January 26, 2009
Last verified: January 2009
  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: Donepezil
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Donepezil Double Blind Trial for ECT Memory Disfunction

Resource links provided by NLM:


Further study details as provided by BeerYaakov Mental Health Center:

Primary Outcome Measures:
  • Data will be analyzed using SPSS for Windows. [ Time Frame: after 5 ECT treatments ] [ Designated as safety issue: No ]
  • Results of the memory and neurocognitive measures will be examined [ Time Frame: after 8 ECT treatments ] [ Designated as safety issue: No ]
  • using repeated MANOVA with before, within and after ECT treatment. [ Time Frame: 1 month after the last ECT treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2007
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Donepezil Drug: Donepezil
Tab.Donepezil 5 mg once daily during ECT treatment and the month after the last ECT treatment
Other Name: Donepezil - Memorit
Placebo Comparator: placebo Drug: Donepezil
Tab.Donepezil 5 mg once daily during ECT treatment and the month after the last ECT treatment
Other Name: Donepezil - Memorit

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Recruiting
Beer Yaacov, Israel, 70350
Contact: Tali Nachshoni, M.D.    972-8-9258372    bynachshoni@beer-ness.health.gov.il   
Principal Investigator: Tali Nachshoni, MD         
Sponsors and Collaborators
BeerYaakov Mental Health Center
Investigators
Principal Investigator: Tali Nachshoni, MD Beer Yaakov Mental Health Center
  More Information

No publications provided

Responsible Party: Marina Kupchik, MD, BeerYaakov Mental Health Center
ClinicalTrials.gov Identifier: NCT00465283     History of Changes
Other Study ID Numbers: Donepezil-180CTIL
Study First Received: April 22, 2007
Last Updated: January 26, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by BeerYaakov Mental Health Center:
Donepezil, ECT, Memory Disfunction

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Memory Disorders
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014