Memory impairment in a common adverse effect of ECT. Current trial examines the effect of adjuvant treatment with Memantin on cognitive function of patients with major depressive disorder. There are two groups, one group receives ECT plus Memantin (20mg/day). The other group receives ECT. Mini mental status examination will be assessed at baseline, at the end of the last ECT session; and 2 weeks after the last session. Depression is assessed by Hamilton depression scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201506203930N38
Registration date:2016-07-01, 1395/04/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-01, 1395/04/11
Registrant information
Name
Ahmad Ghanizadeh
Name of organization / entity
Research Center for Psychiatry and Behavioral Sciences, Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 3070
Email address
ghanizad@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2016-05-28, 1395/03/08
Expected recruitment end date
2017-06-21, 1396/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Memantine to improve cognitive disorders caused by ECT in patients with major depressive disorder
Public title
Effects of Memantine to improve cognitive disorders caused by ECT in patients with major depressive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Aged between 18 to 65, both gender, major depressive dsorder using DSM-IV criteria
Exclusion criteria: serious medical condition, hypothyroidism, bipolar mood disorder, pregnancy
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences
City
Fars
Postal code
--
Approval date
2016-01-25, 1394/11/05
Ethics committee reference number
IR.SUMS.MED.REC.1394.79
Health conditions studied
1
Description of health condition studied
Major depressive disorder
ICD-10 code
F32
ICD-10 code description
Depressive episode
Primary outcomes
1
Description
Depression Score
Timepoint
Baseline, the last session of ECT and 2 weeks after the last session of ECT
Method of measurement
Minimal status Examination
Secondary outcomes
empty
Intervention groups
1
Description
Memantin (5mg/day) started and increase to 20mg/day
Category
Treatment - Drugs
2
Description
Tablet
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Clinic
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences, Vice Chancellor for Research
Full name of responsible person
Seyed Basir Hashemi
Street address
Vice Chancellery for Research Affairs, Shiraz University of Medical Sciences department, Zand Blvd
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences, Vice Chancellor for Research
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
Shiraz University of Medical Sciences
Full name of responsible person
Ali Sahraian
Position
Associate
Other areas of specialty/work
Street address
Hafez hospital
City
Shiraz
Postal code
--
Phone
+98 71 3627 3070
Fax
Email
sahraian@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ahmad Ghanizadeh
Position
Professor of Psychiatry, Director of research center for psychiatry and behavioral sciences
Other areas of specialty/work
Street address
Hafez hospital
City
Shiraz
Postal code
--
Phone
+98 71 3627 3070
Fax
Email
ghanizad@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ali Sahraian
Position
Associate professor of Psychiatry
Other areas of specialty/work
Street address
Hafez Hospital
City
Shiraz
Postal code
Phone
+98 71 3627 9319
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)