Effect of memantine on cognitive impairments after ECT in elderly with major depressive disorder: a randomized double-blind placebo-controlled clinical trial
The effect of memantine on cognitive impairments after Electroconvulsive Therapy in elderly patients with major depressive disorder
Design
The study will be a double-blind clinical trial. Prior to starting medication and ECT sessions, the patient's demographic and depression questionnaires (GDS) will be completed and the Addenbrooke's Cognitive Examination test will also be completed. Patients will be randomly assigned to memantine or placebo. 24 hours after the last ECT session, patients will be re-evaluated for Addenbrooke's Cognitive Examination (ACE) test and GDS and medication side effect checklist and the results of the tests will be analyzed.
Random allocation will be used in this trial based on balance block randomization and by 4:1 blocks. To concealment, table of block will be used by one of researchers, other than interviewer and who assess patients in follow-up visits, to write number of each participants on box of additional drugs. Therefore, all of patients, interviewer and who assess patients in follow-up visits will be unaware if each number belongs to which group.
Settings and conduct
Hospital
Participants/Inclusion and exclusion criteria
Diagnosis of MDD
Clinical Indication for ECT
Lack of diagnosis of dementia or delirium
Lack of Hx of Major Axis I disorder(Schizophrenia, Schizoaffective, Bipolar I,II )
Lack of Medical contraindication for ECT
Intervention groups
The intervention group will receive 10 mg memantine in addition to electroconvulsive therapy from 24 hours before the start of the first session treatment to 24 hours after the last session and the control group receive placebo.
Main outcome variables
Cognition score according to Addenbrook's Cognitive Examination
Depression score according to Geriatric Depression Scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151122025191N2
Registration date:2020-09-17, 1399/06/27
Registration timing:prospective
Last update:2020-09-17, 1399/06/27
Update count:0
Registration date
2020-09-17, 1399/06/27
Registrant information
Name
Behnam Shariati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2331
Email address
shariati.b@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of memantine on cognitive impairments after ECT in elderly with major depressive disorder: a randomized double-blind placebo-controlled clinical trial
Public title
The effect of memantine on post-ECT cognition in depressed elderly
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of Major Depressive Disorder
Clinical Indication for Electroconvulsive Therapy
Exclusion criteria:
Diagnosis of Dementia
Diagnosis of Delirium
Hx of Major Axis I disorder(Schizophrenia, Schizoaffective, Bipolar I,II )
Medical contraindication
Age
From 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:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation will be used in this trial based on balance block randomization and by 4:1 blocks. To do study with concealment, table of block will be used by one of researchers, other than interviewer and who assess patients in follow-up visits, to write number of each participants on box of additional drugs. Therefore, all of patients, interviewer and who assess patients in follow-up visits will be unaware if each number belongs to which group
Blinding (investigator's opinion)
Double blinded
Blinding description
To do study with concealment, table of block will be used by one of researchers, other than interviewer and who assess patients in follow-up visits, to write number of each participants on box of additional drugs. Therefore, all of patients, interviewer and who evaluates patients in follow-up visits will be unaware if each number belongs to which groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
thics committee of Iran University of Medical Sciences
Street address
No. 28, 28th street, Arashmehr Ave., Jalal e Al e Ahmad Highway.,
City
Tehran
Province
Tehran
Postal code
1445713363
Approval date
2020-09-02, 1399/06/12
Ethics committee reference number
IR.IUMS.FMD.REC.1399.376
Health conditions studied
1
Description of health condition studied
Major Depressive Disorder
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
Primary outcomes
1
Description
Addenbrooke's Cognitive Examination Score
Timepoint
before and 24 hour after electroconvulsive treatment
Method of measurement
Addenbrooke's Cognitive Examination-II Score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: From the day before the ECT sessions, the patient will receive 10mg/day Memantine tablet, which will continue until the last ECT session. Each patient will take between 6 and 8 sessions of ECT. According to the ECT protocol, the shock starts bilaterally (bitemporal) with a power of 35% and the minimum seizure required is 25 seconds. If this time is not reached, according to the anesthesiologist's opinion in the same session shock will be repeated. The interval between ECT sessions is every other day, and the energy will be increased in each session from 10 to 15% based on the seizure timer of the previous session to eventually reach 100% of the energy.
Category
Treatment - Drugs
2
Description
Control group: From the day before the ECT sessions, the patient will receive placebo, which will continue until the last ECT session. Each patient will take between 6 and 8 sessions of ECT. According to the ECT protocol, the shock starts bilaterally (bitemporal) with a power of 35% and the minimum seizure required is 25 seconds. If this time is not reached, according to the anesthesiologist's opinion in the same session shock will be repeated. The interval between ECT sessions is every other day, and the energy will be increased in each session from 10 to 15% based on the seizure timer of the previous session to eventually reach 100% of the energy.