To appraise the Memoral herbal drug efficacy on prevention of ECT-induced memory impairment,70 inpatients with mood disorder in Isfahan Noor Hospital who were introduced for electroconvulsive therapy (ECT), were enrolled in a double-blind randomized clinical trial at 2011.They were placed randomly in two groups,and were received either Memoral or placebo since the day before the first ECT until two months after the last ECT session.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201102072232N2
Registration date:2012-01-15, 1390/10/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-01-15, 1390/10/25
Registrant information
Name
Seyed Ghafur Mousavi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1222 2475
Email address
mousavi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Behavioral Sciences Research Center of Isfahan University of Medical Sciences & Goldaru pharmaceutical manufactory
Expected recruitment start date
2010-11-22, 1389/09/01
Expected recruitment end date
2011-08-23, 1390/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the efficacy of Memoral herbal drug on prevention of ECT-induced memory impairment in patients with mood disorder
Public title
Memoral efficacy on prevention of memory impairment
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age range of 15-65; diagnosis of Major Depressive Disorder or Bipolar Disorder; informed acceptance for participating in the study; prescription of at least 4 sessions of ECT by psychiatrist. Exclusion criteria: Dementia or mental retardation; discontinuation of ECT before 4 sessions; refusing cooperation after primary acceptance; delirium during intervention
Age
From 15 years old to 65 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
Behavioural Sciences Research Center (BSRC) of Isfahan University of Medical Sciences (IUMS)
Street address
Noor Medical Center, Ostandarie Ave
City
Isfahan
Postal code
31451-81458
Approval date
2010-06-06, 1389/03/16
Ethics committee reference number
389254
Health conditions studied
1
Description of health condition studied
ECT-induced memory impairment
ICD-10 code
FO4
ICD-10 code description
Organic amnesic syndrome, not induced by alcohol and other psychoactive substances
Primary outcomes
1
Description
Memory
Timepoint
Befor first and fourth ECT session, one and two months after the last session of ECT
Method of measurement
Completion of questionnaire
Secondary outcomes
1
Description
Memoral side effect
Timepoint
Before first and fourth ECT session, one an two months after the last session of ECT
Method of measurement
Questionaire
Intervention groups
1
Description
In intervention group: 3 Memoral cap/day, since the day before ECT, until two months after last session of ECT
Category
Treatment - Drugs
2
Description
In control group: 3 placebo cap/day, since the day before ECT, until two months after the last session of ECT
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Noor Medical Center
Full name of responsible person
Mousavi Seyed Ghafur
Street address
Noor Medical Center, Ostandari Ave.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Behavioural Sciences Research Center of Isfahan University of Medical Sciences
Full name of responsible person
Dr.Abbas Atari
Street address
Behavioural Sciences Reasearch Center, Noor Hospital, Ostandari ave.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Behavioural Sciences Research Center of Isfahan 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
Goldaru pharmaceiutical manufactory
Full name of responsible person
Taghi Ghafghazi
Street address
KM 15 of Isfahan- Shiraz road,Goldaru manufactory
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Goldaru pharmaceiutical manufactory
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
Behavioural Sciences Research Center of Isfahan University of Medical Sciences
Full name of responsible person
Seyed Ghafur Mousavi
Position
Associated Professor/ Board certified of psychiatry
Other areas of specialty/work
Street address
Behavioural Sciences Reseach Center, Noor Medical Center, Ostandari ave.
City
Isfahan
Postal code
Phone
+98 31 1222 2475
Fax
+98 31 1222 2475
Email
mousavi@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Behavioural Sciences Research Center of Isfahan University of Medical Sciences
Full name of responsible person
Seyed Ghafur Mousavi
Position
Associate pofessor/ Board certified of psychiatry
Other areas of specialty/work
Street address
Behavioural Sciences Research Center,Noor Medical Center,Ostandari ave.
City
Isfahan
Postal code
Phone
+98 31 1222 2475
Fax
+98 31 1222 2475
Email
mousavi@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Behavioural Sciences Research Center of Isfahan University of Medical Sciences
Full name of responsible person
Seyed Ghafur Mousavi
Position
Board certified of psychiatry, Associate professor
Other areas of specialty/work
Street address
Behivoural Sciences Reseach Center, Noor Medical Center, Ostandari ave.
City
Isfahan
Postal code
Phone
+98 31 1222 2475
Fax
+98 31 1222 2475
Email
mousavi@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)