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Evaluation of Donepezil effectiveness on prevention of cognitive impairment caused by electroconvulsivetherapy (ECT) in mood disorder patients

Protocol summary

Study aim
Evaluation the effectiveness of Donezepil on prevention of cognitive impairment caused by electroconvulsive therapy in mood disorder patients
Design
Pragmatic, community based, parallel group, double blind, randomised controlled tria
Settings and conduct
94 patients from psychiatric wards of men and women in Hajar Hospital were collected and randomly allocated in either placebo or intervention group.In this study Participant, Care provider(nurses), Investigator,data collectors and Outcome assessor are blinded.Intervention group received Donepezil with dose of 5 mg per day at the start of study to 1 month after the end of electroconvulsivetherapy and placebo group received placebo with the same color and shape like Donepezil. Patient were assessed using MMSE and ACER scales before ECT, before session 4 and a month after end of ECT
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 15-65 years old, Diagnosis of Major depressive disorder, Diagnosis of bipolar disorder, Prescribing at least four session of elecctroconvulsivetherapy, inform consent Exclusion criteria: Dissatisfaction for continued study, Mental retardation, dementia, discontinue treatment before session 4, Delirium during treatment Prohibition of acetyl cholinesterase inhibitors because of a cardiac disorder, chronic obstructive pulmonary disease, Acute peptic ulcer, Lack of literacy
Intervention groups
Intervention group received Donepezil with dose of 5 mg per day at the start of study to 1 month after the end of electroconvulsivetherapy and placebo group received placebo with the same color and shape like Donepezil
Main outcome variables
Decrease cognitive impairment in Donepezil group

General information

Reason for update
Acronym
ECT(electroconvulsivetherapy)
IRCT registration information
IRCT registration number: IRCT20180623040193N1
Registration date: 2018-07-09, 1397/04/18
Registration timing: retrospective

Last update: 2018-07-09, 1397/04/18
Update count: 0
Registration date
2018-07-09, 1397/04/18
Registrant information
Name
Elham Zarean
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3222 0016
Email address
e.zarean@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
2017-07-29, 1396/05/07
Actual recruitment end date
2018-03-20, 1396/12/29
Trial completion date
empty
Scientific title
Evaluation of Donepezil effectiveness on prevention of cognitive impairment caused by electroconvulsivetherapy (ECT) in mood disorder patients
Public title
Donpezil efficacy in prevention of cognitive impairment induced by electroconvulsivetherapy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 15-65 years old Diagnosis of Major depressive disorder by a psychiatrist Diagnosis of bipolar disorder by a psychiatrist Prescribing at least four session of elecctroconvulsivetherapy inform consent
Exclusion criteria:
Dissatisfaction for continued study Mental retardation dementia discontinue treatment before session 4 Delirium during treatment Prohibition of acetyl cholinesterase inhibitors because of a cardiac disorder chronic obstructive pulmonary disease Acute peptic ulcer Lack of literacy
Age
From 15 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 94
Actual sample size reached: 94
Randomization (investigator's opinion)
Randomized
Randomization description
Patient were randomly allocated to either intervention or controlled group using random number generator software
Blinding (investigator's opinion)
Double blinded
Blinding description
Participant, Care provider(nurses), Investigator,data collectors and Outcome assessor are blinded.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
Secondary trial Id
Registration date
empty

2

Registry name
Secondary trial Id
Registration date
empty

3

Registry name
Secondary trial Id
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of SHahrekord University of Medical Sciences
Street address
Kashani Ave,SHahrekord university of medical science
City
SHahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Approval date
2017-07-29, 1396/05/07
Ethics committee reference number
IR.SKUMS.REC.396.49

Health conditions studied

1

Description of health condition studied
Cognitive impairment
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
cognitive impairment
Timepoint
before start of electroconvulsivetherapy, before session 4 and one month after the end of electroconvulsivetherapy
Method of measurement
Addenbrooke’s Cognitive Examination-C, mini mental status examination

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: consumption of 5 mg per day of Donepezi(Produced in Ramofarmin Pharmaceutical Company) before the start of electrocunvulsivetherapy to one month after the end of it
Category
Prevention

2

Description
Control group: Daily consumption of placebo tablet (produced in Raha Pharmaceutical Company with the same shape and color with Donpezil) before starting electrocunvulsivetherapy to one month after the end of it
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Hajar hospital
Full name of responsible person
Elham Zarean
Street address
Weman and men admission wards of psychiatry, Hajar hosp, Parastar Ave, SHahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816758915
Phone
+98 38 3222 0016
Email
e.zarean@skums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Kamal Solati
Street address
Deputy of research and technology, Kashani Ave, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
kamal_solati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Elham Zarean
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Department of Psychiatry, Hajar Hosp, parastar Ave, SHahre-kord
City
SHahre-kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816758915
Phone
+98 38 3222 0016
Fax
Email
ezarean@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Elham Zarean
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Department of Psychiatry, Hajar Hosp, parastar Ave, SHahre-kord
City
SHahre-kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816758915
Phone
+98 38 3222 0016
Fax
Email
ezarean@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Elham Zarean
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Department of Psychiatry, Hajar Hosp, parastar Ave, SHahre-kord
City
SHahre-kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816758915
Phone
+98 38 3222 0016
Fax
Email
ezarean@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
data collected using questioners
When the data will become available and for how long
starting 6 months after publication for 3 months
To whom data/document is available
only available for people working in academic institutions
Under which criteria data/document could be used
Doing similar research
From where data/document is obtainable
email
What processes are involved for a request to access data/document
after receiving request via email, evaluation will be done
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