Objective: The effect of Donepezil on cognitive disturbances due to Selective Serotonine reuotake Inhibitor drugs in major Depressive disorders. type of study: This study is a double blind randomized controlled trial. 76 patients were enrolled based on inclusion and exclusion criteria, and then by a table of random numbers and without the knowledge of the type of intervention, were assigned to two groups. Study population: all patients with Major Depressive disorder from 06.22.2014 to 12.22.2014 were admitted to the Taft psychiatric clinic and clinic Khatamolanbiyae Yazd. Inclusion criteria: patients in the age range 30 to 40 years, Complete the consent form, with Major Depression according to the text of the revised fourth edition of Diagnostic and Statistical Manual of Mental Disorders, treated with selective Serotonin reuptake inhibitors, two months after receiving antidepressant assessment exam Montreal is less than 26. Exclusion criteria: At the same time suffering from major depression and other mental disorders. At the same time suffering from major depression and a physical disorder with features of cognitive impairment including Alzheimer's or other degenerative neurological disorders, head injuries or Hypothyroidism. Concomitant use of Anticholinergic agents, nervous system depressant drugs. Intervention: donepezil 0.5 mg tablet daily for 2 months in the intervention group and donepezil placebo in the control group, after 2 months of using the Montreal Cognitive Assessment Test are evaluated. The consequence: Major Depression
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015092824236N1
Registration date:2016-07-09, 1395/04/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-07-09, 1395/04/19
Registrant information
Name
Fatemeh Hosseini
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3263 2005
Email address
hosseini.k.f@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Donepezil on cognitive disturbances due to Selective Serotonine reuotake Inhibitor drugs in major Depressive disorders
Public title
The effect of Donepezil on Depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients in the age range 30 to 40 years, Complete the consent form, with major Depression according to the text of the revised fourth edition of Diagnostic and Statistical Manual of Mental Disorders, Treated with selective Serotonin reuptake inhibitors, Two months after receiving Antidepressant assessment exam Montreal is less than 26.
Exclusion criteria: At the same time suffering from major Depression and other mental disorders. At the same time suffering from major Depression and a physical disorder with features of cognitive impairment including Alzheimer or other degenerative neurological disorders, head injuries or Hypothyroidism. Concomitant use of Anticholinergic agents and nervous system Depressant drugs
Age
From 30 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Shahid Sadoughi University of Medical Sciences
Street address
Shahid Sadoughi University of Medical Sciences, Bahonar Sq, Yazd
City
Yazd
Postal code
Approval date
2015-05-22, 1394/03/01
Ethics committee reference number
IR.SSU.MEDICINE.REC.1394.374
Health conditions studied
1
Description of health condition studied
Majore Depressive
ICD-10 code
F32.3
ICD-10 code description
Severe depressive episode with psychotic symptoms
Primary outcomes
1
Description
Major Depressive Disorder
Timepoint
2 months after drug consumption
Method of measurement
Montreal Cognitive assessment test
Secondary outcomes
1
Description
Drug side effects
Timepoint
2 months after drug consumption
Method of measurement
Examination and test results
Intervention groups
1
Description
Intervention group: Donepezil 0.5 mg tablet daily for 2 months
Category
Treatment - Drugs
2
Description
In the control group: Placebo Donepezil daily for 2 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taft psychiatric Clinic
Full name of responsible person
Fateme Hosseini
Street address
Psychiatric clinic, Taft
City
Taft
2
Recruitment center
Name of recruitment center
Khatamolanbiyae Clinic
Full name of responsible person
Fateme Hosseini
Street address
Khatamolanbiyae clinic, Taleghani Blv, Yazd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Amir Houshang Mehrparvar
Street address
Shahid Sadoughi University of Medical Sciences, Bahonar Sq,Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Shahid Sadoughi University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Amir Houshang Mehrparvar
Position
Vice Chancellor for Research
Other areas of specialty/work
Street address
Yazd Shahid Sadoughi University of Medical Sciences, Bahonar Sq, Yazd
City
Yazd
Postal code
Phone
+98 35 3726 3733
Fax
Email
ahmehrparvar@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Fatemeh Hosseini
Position
Specialized in Psychiatry
Other areas of specialty/work
Street address
Mental Hospital, Yazd Shahid Sadoughi University of Medical Sciences
City
Yazd
Postal code
Phone
+98 35 3263 2005
Fax
Email
hosseini.k.f@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Fatemeh Hosseini
Position
Specialized in Psychiatry
Other areas of specialty/work
Street address
Mental Hospital, Yazd Shahid Sadoughi University of Medical Sciences
City
Yazd
Postal code
Phone
+98 35 3263 2005
Fax
Email
hosseini.k.f@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)