Evaluation Of the, Galantamine and Memantine co-administration on the Cognitive Deficits induced by Eelctro Convalsive Therapy: A Randomized doubel blind Clinical Trial
In a interventional study about Patients with schizophrenia, schizoaffective, bipolar disorder, major depressive disorder and obsessive turn to Golestan hospita in 1394 these are approved by two cooperator psychiatrists (Criteria DSM-IV-TR) and nominated for shock therapy. They evaluated With regard to the inclusion and exclusion criteria. Patients were randomly divided into four groups of 20 persons . first group: in first 12-24 hours of study patients were given 5 and then 10 mg of Memantine twice a day, in addition they were given 4mg and then 8 mg of Galantamine. the second group:in first 12-24 hours of study patients were given 4 mg and then 8 mg galantamine and placebo twice a day. The third group 12-24 hours of study patients were given 5 and then 10 mg of memantine and placebo twice a day . The fourth group were given two placebo during shock therapy twice a day. (prescring the drug started 12 hours before the shock therpy and continued untill the end of the day shock therapy).Tools which used were Wechsler Digit Span test and Mini Mental Status Questionnaire. Forms were completed at the beginning and end of the study as well as in all 4 groups. statistical tests used for comparing changes within groups and between groups . patiensts, nurses and data monitoring committee are completely unaware of prescription drugs.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015051720913N1
Registration date:2015-10-01, 1394/07/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-10-01, 1394/07/09
Registrant information
Name
Heshmatolah Rahimi
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3038
Email address
rahimi.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2015-04-22, 1394/02/02
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation Of the, Galantamine and Memantine co-administration on the Cognitive Deficits induced by Eelctro Convalsive Therapy: A Randomized doubel blind Clinical Trial
Public title
Evaluation Of the, Galantamine and Memantine co-administration on the Cognitive Deficits
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion critria: Aged between 60-18 years- the number of ECT sessions between 6 and 12- live in the city of Ahvaz. Exclusion criteria: alcohol and drug dependency orabuse during the 3 months prior to admission (except nicotine or caffeine)- diseases of the ducumented (kidney fixed Renal Failure)- epilepsy- Mental Retardation based on clinical assessment and evaluation by phicisian(resident)- delirium- dementia and cognitive disorders- pregnancy and breast feeding-use of memantine and galantamine than 3 months prior to admission- patients receiving thiazide diuretics- ducumented history and drug sensitivity effects with memantine and galantamine .
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:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor for Research and Technological Development
Street address
Ahvaz JundiShapur University of Medical Science
City
Ahvaz
Postal code
6135715794
Approval date
2015-03-22, 1394/01/02
Ethics committee reference number
IR.AJUMS.REC.1394.66
Health conditions studied
1
Description of health condition studied
Cognition disorder due to Electro Convalsive Therapy
ICD-10 code
G31.9
ICD-10 code description
Degenerative disease of nervous system, unspecified
Primary outcomes
1
Description
Galantamine-Memantine-ECT numbers-MMSE Test score
Timepoint
One day before and one day after Electro Convalsive Therapy
Method of measurement
Questionary scors MMSE-Questionary Digit Span of Wechsler
Secondary outcomes
empty
Intervention groups
1
Description
First group:A day before starting the study 4 mg of Galantamine every 12 hours prescript and 24 hour later achive to 8 mg every 12 hours.although a day befor starting the study 5 mg of Memantine every 12 hours start and achive to 10 mg every 12 hours.dose contiues until the of Electro Convalsive Therapy.
Category
Treatment - Drugs
2
Description
Second group:A day before starting the study 4 mg of Galantamine every 12 hours prescript and 24 hour later achive to 8 mg every 12 hours.although a day befor starting the study 5 mg of Placebo every 12 hours start and achive to 10 mg every 12 hours.dose contiues until the end of Electro Convalsive Therapy.
Category
Treatment - Drugs
3
Description
Third group:A day before starting the study 5mg of Memantine every 12 hours prescript and 24 hour later achive to 10 mg every 12 hours.although a day befor starting the study 4 mg of Placebo every 12 hours start and achive to 8 mg every 12 hours.dose contiues until the of Electro Convalsive Therapy.
Category
Treatment - Drugs
4
Description
Fourth group:A day before starting the study 4 mg of Placebo every 12 hours prescript and 24 hour later achive to 8 mg every 12 hours.although a day befor starting the study 5 mg of Placebo every 12 hours start and achive to 10 mg every 12 hours.dose contiues until the of Electro Convalsive Therapy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Dr.Heshmatolah Rahimi
Street address
Psychiatrist of Golestan hospital
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr.Heshmatolah Rahimi
Street address
No 27, Ansar Complex, Part1, 16th West Street, Kian pars
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Ahvaz Jundishapur of Medical Sciences
Full name of responsible person
Dr.Heshmatolah Rahimi
Street address
Ansar Complex, Part1, 16th West Street, Kian pars
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur of Medical Sciences
Proportion provided by this source
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
Ahvaz Jundishapur of Medical Science
Full name of responsible person
Dr.Heshmatolah Rahimi
Position
Resident
Other areas of specialty/work
Street address
No27, Ansar complex, Part1, 16th West Street, Kian pars
City
Ahvaz
Postal code
Phone
+98 61 3338 1913
Fax
Email
Rahimi.hsht@gmil.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur Medical Science
Full name of responsible person
Seyed Mohammad Taghi Mansoori
Position
Asistant
Other areas of specialty/work
Street address
Pharmacology Group of Medical Science
City
Ahvaz
Postal code
Phone
+91 33178795
Fax
Email
Mansouri_smt@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)