Comparison of cognitive function in patients receiving Donpezil, Rivastigmine, and control group before and after receiving ECT
Design
Randomized Double Blind Clinical trail with control group
Settings and conduct
60 patients aged 18-60 years old admitted to the psychiatric department of Golestan Hospital who had been subjected to ECT were randomly divided into three groups of 20 people. The first group received Rivastigmine, the second group received Donepezil, and the third group received placebo. All drugs and placebos are similar in shape, color and odor. The patients and the executor of plan unaware of which of the people in the three groups receive medication or placebo.
Participants/Inclusion and exclusion criteria
Inclusive Criteria:
Patients between 18 and 60 ages
Patients with mood and Psychotic disorders
Candidate for treatment with 6 to 12 ECT sessions
Exclusive Criteria:
Neurological and Somatic Diseases and cognitive impairments, Pregnancy and Breast feeding
Having ECT treatment in past 6 months
Having treatment with Rivastigmine and Donepezil in past 3 months
MMSE<24
Substance and Alcohol use
Intervention groups
Giving rivastigmine capsule to the first intervention group, donepezil tablet to the second intervention group, and Placebo to the control group
Main outcome variables
Cognitive Function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171229038124N1
Registration date:2018-08-04, 1397/05/13
Registration timing:retrospective
Last update:2018-08-04, 1397/05/13
Update count:0
Registration date
2018-08-04, 1397/05/13
Registrant information
Name
Masoumeh Nazarinasab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3038
Email address
nazarinasab-m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-06-21, 1397/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Donepezil and Rivastigmine co – administration on the cognitive deficits induced by EcT: A Randomized Double Blind Clinical Trial
Public title
Evaluation of the Donepezil and Rivastigmine co – administration on the cognitive deficits induced by EcT: A Randomized Double Blind Clinical Trial
1. The participants, while aware that the placebo and two Donepezil and Rivastigmine drugs were used in this study, were unaware of the medicine being given to them.
2. In this study, the researcher does not know how each participant is undergoing treatment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Golestan Hospital, Ahvaz Joundishapour University of Medical Sciences, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Approval date
2017-11-11, 1396/08/20
Ethics committee reference number
IR.AJUMS.REC.1396.609
Health conditions studied
1
Description of health condition studied
EcT in patients with Mood Disorders
ICD-10 code
F31
ICD-10 code description
Bipolar affective disorder
Primary outcomes
1
Description
Evaluation of cognitive function by MMSE
Timepoint
In the first, middle and end of the period of ECT Therapy
Method of measurement
MMSE
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Tablet Donepezil 5 mg daily for 2 weeks
Category
Other
2
Description
Intervention group: Cap Rivastigmine 1.5 mg twice a day for one week and 3 mg twice a day until the end of study
Category
Other
3
Description
Control group: Placebo
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Masoumeh Nazarinasab
Street address
Golestan Hospital, Ahvaz Joundishapour University of Medical Sciences, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3038
Email
nazarinasab-m@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Mohammad Badavi
Street address
Golestan Hospital, Ahvaz Jundishapur University of Medical Sciences, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 1984
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Masoumeh Nazarinasab
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Golestan Hospital, Ahvaz Joundishapour University of Medical Sciences, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61337430011
Email
Nazarinasab-m@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Masoumeh Nazarinasab
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Golestan Hospital, Ahvaz Joundishapour University of Medical Sciences, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61337430011
Email
Nazarinasab-m@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Masoumeh Nazerinasab
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Golestan Hospital, Ahvaz Joundishapour University of Medical Sciences, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61337430011
Email
Nazarinasab-m@ajums.ac.ir
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Some of the data could be shared.
When the data will become available and for how long
It would be available 6 months after publication of the results
To whom data/document is available
University Researchers
Under which criteria data/document could be used
For research and treatment issues
From where data/document is obtainable
To published article
What processes are involved for a request to access data/document