Donepezil Double Blind Trial for ECT Memory Disfunction

NCT00465283 | Unknown Phase 4

• 1 other identifier: Donepezil-180CTIL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder

Keywords

Donepezil, ECT, Memory Disfunction

Outcome Measures

Primary Outcomes (3)

• Data will be analyzed using SPSS for Windows.

  after 5 ECT treatments

• Results of the memory and neurocognitive measures will be examined

  after 8 ECT treatments

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

  1 month after the last ECT treatment

Study Arms (2)

Donepezil

ACTIVE COMPARATOR

Drug: Donepezil

placebo

PLACEBO COMPARATOR

Drug: Donepezil

Interventions

Donepezil DRUG

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

Also known as: Donepezil - Memorit

Donepezil; placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• BeerYaakov Mental Health Center: lead

Study Sites (1)

Beer Yaakov MHC

Beer Yaacov, 70350, Israel

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Epilepsy, Rolandic

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Epilepsies, Partial; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Tali Nachshoni, MD

  Beer Yaakov Mental Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tali Nachshoni, MD

CONTACT

972-8-9258372; bynachshoni@beer-ness.health.gov.il

Marina Kupchik, MD

CONTACT

972-89258382; kupchik@beer-ness.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: April 22, 2007
• First Posted: April 24, 2007
• Study Start: May 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: January 27, 2009

Record last verified: 2009-01

Locations

IL (1)