The aim of this study assess the efficacy and safety of Donepezil in the prevention of cognitive impairments due to Electro Convulsive Therapy.
Method and Material: 70 adult patients that randomly divided into two groups (35 intervention, 35 placebo) with:
Inclusion criteria :Patients referring to Sanandaj Qods Hospital ; Age between 18-60 years old; 2-8 sessions Electro Convulsive Therapy; The Patient who fill out the testimonial form; and
Exclusion criteria: Alcohol and substance dependence except Caffeine and Nicotine in past 3 months; History of Epilepsy; Proven Intelligent Disability or diagnosed with assistant; History of Delirium, Dementia and Cognitive Disorders ;Pregnancy and breast-feeding; History of using Doneprzil in past 3 months; History of using Paroxetine and Ketoconazol; Donepezil sensitivity; History of Cardiovascular disease; History of Brain Stroke in past 6 months; Head trauma and surgery or traumatic Brain injury in past year
Various mental disorders during the Electro Convulsive Therapy period who show cognitive impairments randomly receive Donepezil(5mg/day)or placebo treatment (Randomized Double blind Clinical Trial) .wechsler adult intelligence scale(backward memory span, digit span...) and mini mental status examination are used to assess the cognition function 24 hours before and after the Electro Convulsive Therapy .
General information
Acronym
Sanandaj Donepezil study
IRCT registration information
IRCT registration number:IRCT2017022532766N1
Registration date:2017-04-03, 1396/01/14
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-04-03, 1396/01/14
Registrant information
Name
Akbar Qanbarzadeh Chelan sofla
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 3366 4653
Email address
akbar.qanbarzadeh@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of Medical Sciences
Expected recruitment start date
2017-04-06, 1396/01/17
Expected recruitment end date
2017-05-05, 1396/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Donepezil in cognitive impairments of patients under Electro Convulsive Therapy (Randomized Double blind Clinical Trial)
Public title
Efficacy of Donepezil in Amnisia due to Electro Convulsive Therapy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria :Patients referring to Sanandaj Qods Hospital ; Age between 18-60 years old; 2-8 sessions Electro Convulsive Therapy; The Patient who fill out the testimonial form; and
Exclusion criteria: Alcohol and substance dependence except Caffeine and Nicotine in past 3 months; History of Epilepsy; Proven Intelligent Disability or diagnosed with assistant; History of Delirium, Dementia and Cognitive Disorders ;Pregnancy and breast-feeding; History of using Doneprzil in past 3 months; History of using Paroxetine and Ketoconazol; Donepezil sensitivity; History of Cardiovascular disease; History of Brain Stroke in past 6 months; Head trauma and surgery or traumatic Brain injury in past year
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Kurdistan University of Medical Sciences
Street address
Pasdaran Ave.
City
Sanandaj
Postal code
6617713446
Approval date
2017-02-13, 1395/11/25
Ethics committee reference number
IR.MUK.REC.1395.339
Health conditions studied
1
Description of health condition studied
Schizophrenia,Schizoaffective,Mood dosorders and Obsessive-compulsive disorders