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IRCT20151122025191N2 IRCT 2020-09-17 Iran University of Medical Sciences The effect of memantine on post-ECT cognition in depressed elderly Effect of memantine on cognitive impairments after ECT in elderly with major depressive disorder: a randomized double-blind placebo-controlled clinical trial 2020-10-22 anticipated 40 Complete https://irct.ir/trial/45769 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Major Depressive Disorder. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after being unidentified When: Access will be allowed 3 month after publication To whom: Researchers Conditions: For use in meta-analysis studies with a written request stating the reason for the request and documentation Where to obtain: Dr Behnam Shariati How to obtain: By Sending an email to the corresponding person along with mentioning the documents and the reason for the request. Comments:
public Behnam Shariati
School of Behavioral Sciences and Mental Health., Shahid Mansouri Street., Niyayesh Street., Satarkhan Avenue., Tehran., Iran
Tehran Iran (Islamic Republic of) 1445613111 +98 21 6655 1655 behnamshariatimd@gmail.com Iran University of Medical Sciences scientific Behnam Shariati
School of Behavioral Sciences and Mental Health Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue, Tehran, Iran
Tehran Iran (Islamic Republic of) 1445613111 +98 21 6655 1655 behnamshariatimd@gmail.cim Iran University of Medical Sciences Iran (Islamic Republic of) Diagnosis of Major Depressive Disorder Clinical Indication for Electroconvulsive Therapy 60 years no limit Both Diagnosis of Dementia Diagnosis of Delirium Hx of Major Axis I disorder(Schizophrenia, Schizoaffective, Bipolar I,II ) Medical contraindication F32 Major depressive disorder, single episode Treatment - Drugs Placebo 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. 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. Addenbrooke's Cognitive Examination Score. Timepoint: before and 24 hour after electroconvulsive treatment. Method of measurement: Addenbrooke's Cognitive Examination-II Score. Iran University of Medical Sciences Approved 2020-09-02 thics committee of Iran University of Medical Sciences No. 28, 28th street, Arashmehr Ave., Jalal e Al e Ahmad Highway., Tehran Tehran Iran (Islamic Republic of)