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IRCT20190119042417N2 IRCT 2022-06-01 Shahid Beheshti University of Medical Sciences Evaluation the effectiveness of rivastigmine and memantine in improving cognitive problems due to electroconvulsive therapy Comparison of the effectiveness of rivastigmine and memantine in improving cognitive problems due to electroconvulsive therapy 2022-06-05 anticipated 45 Complete https://irct.ir/trial/63711 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, we will use the restricted randomization method of block randomization. The size of all the blocks is the same and in this 3-group trial, we will have blocks of 9 people (including 3 people receiving memantine, 3 people receiving rivastigmine, and 3 people receiving placebo). Random allocation software is used to generate random sequences. Sequentially numbered, sealed opaque envelopes will be used to conceal allocation concealment. The random sequence created is registered on a card and the cards are placed in the letter envelopes in order. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. For the participants, based on the order of entry into the study, one of the envelopes is opened and the assigned group of the participant is determined, Blinding description: Study participants, the person performing the memory tests (psychiatry resident) and the person delivering the drug to the patient (ward nurse) will not be aware of the type of drug delivered to the patient (memantine, rivastigmine or placebo). The person performing the tests will be same person (psychiatry resident) and the drugs will be prepared in the form of capsules with the help of the laboratory of the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences and in numbered boxes (drug No. 1, drug No. 2 and drug No. 3) will be delivered to the researcher and the researcher will be unaware of the type of drug until the data analysis is completed. 3 Psychiatric disorders with electroconvulsive therapy (ECT) indication. Intervention 1: Intervention group 1: The day before receiving ECT and after the Montreal cognitive test, rivastigmine is started at a dose of 1.5 mg in 24 hours and increases to 3 mg (2 capsules) in 24 hours after one week. The drug will be taken once a day after lunch and will continue for 2 weeks. The rivastigmine used is rivastigmine 1.5 mg made by Razak Company, which has the same appearance as the drugs of memantine and placebo (prepared with the help of the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences). It will be delivered to the researcher in the form of capsules in numbered boxes. Intervention 2: Intervention group 2: The day before receiving ECT and after the Montreal cognitive test, memantine is started at a dose of 5 mg in 24 hours and increases to 10 mg (2 capsules) in 24 hours after one week. The drug will be taken once a day after lunch and will continue for 2 weeks. The memantine used is memantine 5 mg made by Sobhan Company, which has the same appearance as the drugs of rivastigmine and placebo (prepared with the help of the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences). It will be delivered to the researcher in the form of capsules in numbered boxes. Intervention 3: Control group: The day before receiving the electroshock and after the Montreal Cognitive Test, placebo starts with a dose of one capsule in 24 hours and increases to 2 capsules in 24 hours after a week. The placebo will be taken once a day, after lunch, and will last for 2 weeks. The placebo used in the same appearance as the drugs of rivastigmine and memantine (prepared with the help of the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences). It will be delivered to the researcher in the form of capsules in numbered boxes. Yes - There is a plan to make this available What will be shared: Information about the main outcome can be shared. When: Access period starts 6 months after the results are published. To whom: Researchers working in academic and scientific institutions. Conditions: For use in meta-analyzes Where to obtain: Dr. Alireza Shamsi How to obtain: Written request Comments:
public Parniyan Molaee
Nezamabad, Madani Street, Emam Hossein Hospital
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7755 1023 parnianmolaee@yahoo.com Shahid Beheshti University of Medical Sciences scientific Alireza Shamsi
Velenjak, Daneshjoo Squire, Arabi Street, Taleghani Hospital
Tehran Iran (Islamic Republic of) 1985711151 +98 21 2303 1357 ar.shamsi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Being in the age range of 18-60 years. Being a candidate to receive electroconvulsive therapy. Collaborate to perform Montreal cognitive assessment. Having informed consent to participate in the study. 18 years 60 years Both History of neurocognitive disorders such as delirium and dementia History of cardiac conductive disorder and arrhythmia History of hepatic, renal, thyroid, and seizure disorders History of sensitivity to rivastigmine and memantine History of electroconvulsive therapy within the the past 6 months Taking calcium channel blockers and cox-inhibitors Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: The day before receiving ECT and after the Montreal cognitive test, rivastigmine is started at a dose of 1.5 mg in 24 hours and increases to 3 mg (2 capsules) in 24 hours after one week. The drug will be taken once a day after lunch and will continue for 2 weeks. The rivastigmine used is rivastigmine 1.5 mg made by Razak Company, which has the same appearance as the drugs of memantine and placebo (prepared with the help of the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences). It will be delivered to the researcher in the form of capsules in numbered boxes. Intervention group 2: The day before receiving ECT and after the Montreal cognitive test, memantine is started at a dose of 5 mg in 24 hours and increases to 10 mg (2 capsules) in 24 hours after one week. The drug will be taken once a day after lunch and will continue for 2 weeks. The memantine used is memantine 5 mg made by Sobhan Company, which has the same appearance as the drugs of rivastigmine and placebo (prepared with the help of the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences). It will be delivered to the researcher in the form of capsules in numbered boxes. Control group: The day before receiving the electroshock and after the Montreal Cognitive Test, placebo starts with a dose of one capsule in 24 hours and increases to 2 capsules in 24 hours after a week. The placebo will be taken once a day, after lunch, and will last for 2 weeks. The placebo used in the same appearance as the drugs of rivastigmine and memantine (prepared with the help of the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences). It will be delivered to the researcher in the form of capsules in numbered boxes. Cognitive impairment. Timepoint: One day before starting ECT, 2 and 6 weeks after starting ECT. Method of measurement: Montreal Cognitive Scale (MOCA). Shahid Beheshti University of Medical Sciences Approved 2021-03-02 Ethics Committee of Shahid Beheshti University of Medical Sciences Daneshjo squire, Arabi street Tehran Tehran Iran (Islamic Republic of)