The aim of present study is to comparison effect of memantine and melatonin on cognitive disorder after doing Electroconvulsive therapy (ECT)
Design
Clinical trial double blind randomized
Settings and conduct
Inpatient ward of psychchiatric in Baqiyatallah hospital
Participants/Inclusion and exclusion criteria
Inclusion criterion: patients needed ECT.
Exclusion criteria: history of sensitivity to memantine or melatonin; pregnancy or lactation.
Intervention groups
Comparison effect of melatonin 3 mg per day and memantine 5 mg per day in memory decrease induced of ECT
Main outcome variables
MMSE questionnaire score
General information
Reason for update
Acronym
ECT Electro convulsive therapy
IRCT registration information
IRCT registration number:IRCT20121021011192N8
Registration date:2019-10-02, 1398/07/10
Registration timing:retrospective
Last update:2019-10-02, 1398/07/10
Update count:0
Registration date
2019-10-02, 1398/07/10
Registrant information
Name
Mohammad Abbasinazari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
m_abbasi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of memantine and melatonin in alleviation of cognitive impairment after ECT
Public title
The comparison of Memantine and Melatonin on memory
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing ECT in Baqhiatallah hospital
Taking consent form
Exclusion criteria:
Patients with history of allergy to melatonin
Patients with history of allergy to memantine
Addict patients
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
En simple, block, individual, using table of random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, principle investigator, healthcare providers (Physicians, nurses) who care for participants, data collector and outcome assessors during the trial will be blinded.Preparing memantine and melatonin in blind format will be done just by one responsible co-researcher has no involvement in running study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University
Street address
School of Pharmacy, Nyayesh cross, Valiasr street
City
Tehran
Province
Tehran
Postal code
1996835113
Approval date
2018-10-15, 1397/07/23
Ethics committee reference number
IR.IAU.PS.REC.1397.335
Health conditions studied
1
Description of health condition studied
Cognitive disorder
ICD-10 code
F99
ICD-10 code description
Mental disorder, not otherwise specified
Primary outcomes
1
Description
Change in Mimi Mental Status Exam (MMSE) score
Timepoint
1 month
Method of measurement
questionnaire of Mimi Mental Status Exam (MMSE)
Secondary outcomes
empty
Intervention groups
1
Description
Group 1 Intervention: use of 5 mg per day memantine aboreyhan for 1 month
Category
Treatment - Drugs
2
Description
Group 2 Intervention: use of 3 mg per day melatonin nature made USA for 1 month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Psychotherapy clinic of Baqiyatallah hospital
Full name of responsible person
Taleb Badri
Street address
Molasadra street, Sheikh Bahaii junction
City
Tehran
Province
Tehran
Postal code
3458025321
Phone
+98 21 8887 3704
Email
farshadpharm@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nima Naderi
Street address
School of Pharmacy, Nyayesh cross, Valiasr street
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8887 3704
Email
nimanaderi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Abbasi Nazari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Nyayesh cross, Valiasr street
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8887 3704
Email
m_abbasi@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Abbasinazari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Nyayesh junction, Valiasr street
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8887 3704
Email
m_abbasi@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Abbasi Nazari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Nyayesh cross, Valiasr street
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8887 3704
Email
m_abbasi@sbmu.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
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
Undecided - It is not yet known if there will be a plan to make this available
When the data will become available and for how long
Undecided - It is not yet known if there will be a plan to make this available
To whom data/document is available
only available for people working in academic institutions
Under which criteria data/document could be used
Undecided - It is not yet known if there will be a plan to make this available
From where data/document is obtainable
Email to m_abbasi@sbmu.ac.ir
Mohammad Abbasinazari
What processes are involved for a request to access data/document