Comparison of 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

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 45 patients

Patients admitted to the psychosomatic and psychiatric wards of Taleghani Hospital and the psychiatric ward of Emam Hossein Hospital are included in the study if they meet the inclusion criteria and are randomly divided into 3 groups receiving rivastigmine, memantine and placebo. Cognitive function of patients is assessed using the Montreal Cognitive Test one day before the start of ECT, two and six weeks after the start of treatment. The patient, the person performing the memory tests, the person delivering the drug to the patient, and the person analyzing the results will not be aware of the type of drug delivered to the patient.

Inclusion criteria: age between 18-60, cooperation ability with our study, informed consent Exclusion criteria: history of neurocognitive disorder 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 ECT within the the past 6 months, taking calcium channel blockers and cox-inhibitors.

Intervention group 1: Rivastigmine starts with a dose of 1.5 mg in 24 hours and increases to 3 mg in 24 hours after a week. Intervention group 2: Memantine starts with a dose of 5 mg in 24 hours and increases to 10 mg in 24 hours after a week. Control group: Placebo starts with a dose of one capsule in 24 hours and increases to 2 capsules in 24 hours after a week. The duration of drug use in 3 groups will be 2 weeks.

Montreal Cognitive Scale score

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.

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.

Information about the main outcome can be shared.

Access period starts 6 months after the results are published.

Researchers working in academic and scientific institutions.

For use in meta-analyzes

Dr. Alireza Shamsi

Written request