Donepezil Double Blind Trial for ECT Memory Disfunction | NCT00465283

Studies
Donepezil Double Blind Trial for ECT Memory Disfunction

NCT00465283

Sponsor

BeerYaakov Mental Health Center

Status

Unknown status

Last Update Posted

Jan 27, 2009Estimated

Enrollment

40Estimated

Phase

Phase 4

Conditions

Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder

Interventions

Donepezil

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Jan 2010Estimated

Completion Date

Jan 2010Estimated

First Submitted Date

Apr 22, 2007

First Submission Date that Met QC Criteria

Apr 22, 2007

First Posted Date

Apr 24, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2009

Last Update Posted Date

Jan 27, 2009Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Donepezil	Active Comparator		Drug: Donepezil
placebo	Placebo Comparator		Drug: Donepezil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Donepezil	Drug	Tab.Donepezil 5 mg once daily during ECT treatment and the month after the last ECT treatment	Donepezil placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
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

Overall Officials

Name	Affiliation	Role
Tali Nachshoni, MD	Beer Yaakov Mental Health Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beer Yaakov MHC	Recruiting	Beer Yaacov		70350	Israel

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia
D011618	Psychotic Disorders
D019305	Epilepsy, Rolandic

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders
D004828	Epilepsies, Partial
D004827	Epilepsy

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077265	Donepezil

Ancestor Terms

ID	Term
D007189	Indans
D007192	Indenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided