Efficacy of galantamin on cognitive performance of patients under electro convulsive therapy
Design
Clinical trial, with control group, double blind, randomized, phase 3, 90 patients
Settings and conduct
90 patients from psychiatric wards, men and women, in Sanandaj Qods hospital were candidate for ECT treatment and had the criteria to enter study and collected randomly allocated in either placebo or intervention groups. In this study participant, care provider (nurse), investigator were blind. In both groups in addition to electroconvulsive therapy, 4mg Galantamine capsules of one form and placebo in the other group were prescribed twice a day. Patients were evaluated with wechsler test and Mini mental status examination on the day before the intervention and after the third session and after the end of the electroconvulsive therapy.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of patient between 18-60 years.the patients or their legal guardian must sign an informed consent form. Number of sessions of ECT between 4-8, Exclusion criteria: Alcohol&drug abuse or dependance, renal failure, ischemic heart disease, stroke in last 6 months, Delirium and Dementia, pregnancy and lactation, history of using galantamin in last 3 months, Galantamine sensitivity, mental retardation.
Intervention groups
One group received 8mg galantamin daily. Other group received placebo
Main outcome variables
Memory
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200207046404N1
Registration date:2020-04-23, 1399/02/04
Registration timing:retrospective
Last update:2020-04-23, 1399/02/04
Update count:0
Registration date
2020-04-23, 1399/02/04
Registrant information
Name
Aziz alah Ghanbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3362 6968
Email address
ravanmehr20@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-01, 1397/07/09
Expected recruitment end date
2019-05-01, 1398/02/11
Actual recruitment start date
2018-10-01, 1397/07/09
Actual recruitment end date
2019-05-01, 1398/02/11
Trial completion date
2019-09-02, 1398/06/11
Scientific title
Efficacy of galantamine on cognitive performance of patients under electro convulsive therapy
Public title
Efficacy of galantamine on cognitive performance
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged between 18-60 years
Patients or their legal guardian must sign an informed consent form
Number of sessions of ECT between 4-8
Exclusion criteria:
Alcohol & drug abuse or dependence
Renal failure
Ischemic heart disease
Stroke in last 6 months
Delirium &Dementia
Pregnancy & Lactation
History of using Galantamine in past 3 months
Galantamine sensitivity
Mental retardation
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
75
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients into two intervention or control groups,patients are randomly divided into two groups A and B with a table of random numbers (random numbers table is a collection of numbers that are generated without a specific pattern or order and completely randomized then samples are randomly selected by randomizer software).The numbers are given to the pharmacist, based on which he determines the medicinal packages of galantamine and placebo and no one but him knows which drug and which placebo it is, and the number of each package is recorded in the patient's file.
Blinding (investigator's opinion)
Double blinded
Blinding description
Packages containing medications were prepared by pharmacist and nobody knew their content except the pharmacist. Patients names were randomly assigned into blocks A and B based on random number table insert on the drug envelops and were given medication packages until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kurdestan University of Medical Sciences
Street address
Kurdestan Medical Sciences Univercity,Pasdaran Ave, Sanandaj Town
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Approval date
2018-07-03, 1397/04/12
Ethics committee reference number
IR.MUK.REC.1397.096
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
2
Description of health condition studied
Schizoaffective
ICD-10 code
F25
ICD-10 code description
Schizoaffective disorders
3
Description of health condition studied
Mood disorders
ICD-10 code
F06.34
ICD-10 code description
Mood disorder due to known physiological condition with mixed features
4
Description of health condition studied
Obsessive- compulsive disorders
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
Memory
Timepoint
1day before begining and after session 3 and after the electroconvulsive therapy
Method of measurement
Wechsler, mini mental statuse examination
Secondary outcomes
1
Description
Nausea
Timepoint
During intervention( once a day for 15 days)
Method of measurement
Patient self report
2
Description
Confusion
Timepoint
During intervention(once a day for 15 days)
Method of measurement
Patient self report
3
Description
Dizziness
Timepoint
During intervention(once a day for 15 days)
Method of measurement
Patient self report
Intervention groups
1
Description
Galantamin 4mg capsules BID in the intervention group until the end of ECT treatment.(for 15 days)
Category
Prevention
2
Description
Control group: received placebo capsules BID until the end of ECT treatment.(for 15 days)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Qods Hospital
Full name of responsible person
Azizalah Ghanbari
Street address
Pasdaran Ave
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3362 6968
Fax
+98 87 3366 1340
Email
Ravanmehr20@gmail.com
Web page address
Http://muk.ac.ir/muk/Hospital/Qods.aspx
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Azizalah Ghanbari
Street address
Pasdaran Ave
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3362 6968
Fax
+98 87 3366 1340
Email
Ravanmehr20@gmail.com
Web page address
Http://muk.ac.ir/muk/Hospital/Qods.aspx
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Hojat Esfandiyary
Position
Psychologist
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Pasdaran Ave
City
Sanandaj
Province
Kurdistan
Postal code
986617713446+
Phone
+98 87 3362 6968
Fax
+98 87 3366 1340
Email
Esfandyari@gmail.com
Web page address
Http://.Muk.ac.ir/Muk/Hospital/Qods.aspx
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Azizalah Ghanbari
Position
Psychiatrist assistant
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Pasdaran ave
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3362 6968
Fax
+98 87 3366 1340
Email
Ravanmehr20@gmail.com
Web page address
Http://muk.ac.ir/muk/Hospital/Qods.aspx
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Azizalah Ghanbari
Position
Psychiatrist Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Pasdaran Ave
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3362 6968
Fax
+98 87 3366 1340
Email
Ravanmehr20@gmail.com
Web page address
Http://muk.ac.ir/muk/hospital/Qods.aspx
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available