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IRCT20241203063932N1 IRCT 2025-08-02 Zanjan University of Medical Sciences Comparison of Ketamine and Sodium Thiopental effects in Electroconvulsive Therapy anesthesia on Depression and Suicidal Ideation ECT A Comparative Study of the Efficacy of Ketamine versus Sodium Thiopental as Anesthetic Agents in Electroconvulsive Therapy (ECT) on Reducing Depressive Symptoms and Suicidal Ideation in Patients with Major Depressive Disorder 2025-08-23 anticipated 34 Complete https://irct.ir/trial/80734 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Convenience sampling will be performed among eligible patients. Patients will be assigned to two study groups using block randomization. In each block of 2, one patient will be assigned to the Ketamine group and one patient to the Sodium Thiopental group. Random sequences will be generated using Random Allocation Software and allocation concealment will be used to prevent bias. The generated sequences will be placed in sealed envelopes and maintained by an independent person from the research team. After final confirmation of the patient's eligibility, the relevant envelope will be opened and the treatment group will be determined, Blinding description: Given that the drugs are similar in appearance, color, and volume, participants (patients) will be kept blind and will not know which group (Ketamine or Sodium Thiopental) they are in. Clinical observers, including the Anesthesiologist and Anesthesia Technician, will be unblinded to group patients, determine the type of drug and its injection, and control possible side effects. The principal investigator (supervisors and myself) will be blinded to prevent bias and will only see the group numbers. Outcome assessors, including the Psychiatrist who records the Depression score, will be blinded. The data analyst will be blinded and the data will be presented with group codes so that the analyst is unaware of the actual allocation, and the codes will be opened after the initial analysis is complete. The safety and data monitoring committee will be unblinded to learn about the details of the interventions and side effects. 2 Major Depressive Disorder. Intervention 1: Intervention group 1: Ketamine, an anesthetic and NMDA receptor antagonist, is administered intravenously to patients at a dose of 2 mg/kg before ECT. Intervention 2: Intervention group 2: Thiopental sodium, an anesthetic drug, is injected intravenously at a dose of two to three milligrams per kilogram before ECT. Yes - There is a plan to make this available What will be shared: In this study, data related to participants, such as depressive symptoms reported before and after receiving treatment and information related to the main outcome (depression score on the Montgomery Depression Inventory), will be shared after de-identifying individuals. When: Access period starts 6 months after results are published. To whom: Study data and documentation will be available to medical universities, academic institutions, and psychiatric hospitals. Study data and documentation will be available to medical universities, academic institutions, and psychiatric hospitals. Conditions: Data and documents will be available in a non-personally identifiable form to individuals active in academic and scientific systems for additional research and review, presentation in groups and classes, and for uploading to cyberspace for education Where to obtain: To receive data, my email address is sa.dnzn@gmail.com and my work address is Zanjan-Shahid Beheshti Psychiatric Hospital. Dr Sadaf Danehzan How to obtain: To receive the documents, applicants must email me their details along with the reason for requesting the materials. After reviewing the details and relevant materials, the documents will be sent via email within a week. Comments:
public Sadaf Danehzan
North Saadi Ave., Ark Blvd
Zanjan Iran (Islamic Republic of) 4513615788 +98 24 3354 4003 s.danehzan@sina.zums.ac.ir Zanjan University of Medical Sciences scientific Sadaf Danehzan
North Saadi Ave., Ark Blvd
Zanjan Iran (Islamic Republic of) 4513615788 +98 24 3354 4003 s.danehzan@sina.zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Patients 18 years and older of all genders MDD diagnosis confirmed by DSM-V criteria Active Suicidal Ideation Written informed consent 18 years no limit Both Patients with Bipolar Mood Disorder Patients with Schizophrenia Patients with Schizoaffective Disorder History of Substance abuse within the past Three Months History of significant adverse effects associated with Anesthetic agents History of Cardiovascular Diseases Patients with body Implants(e.g., Pacemakers, Intracranial Electrodes, etc.) Pregnant Women Contraindications to ECT(e.g., extensive Brain lesions, elevated Intracranial Pressure and recent Myocardial Infarction) Non-consenting individuals History of Hypertension, Cardiac conduction disorders and Tachycardia F33 Major depressive disorder, recurrent Treatment - Drugs Treatment - Drugs Intervention group 1: Ketamine, an anesthetic and NMDA receptor antagonist, is administered intravenously to patients at a dose of 2 mg/kg before ECT. Intervention group 2: Thiopental sodium, an anesthetic drug, is injected intravenously at a dose of two to three milligrams per kilogram before ECT. Depression score on the Montgomery-Åsberg Depression Rating Scale. Timepoint: Depression and suicidal ideation will be assessed before starting ECT with ketamine and sodium thiopental, after 6 ECT sessions, and also 4 weeks after completing the sessions. Method of measurement: Montgomery-Åsberg Depression Rating Scale. Zanjan University of Medical Sciences Approved 2025-04-08 Ethics committee of Zanjan University of Medical Sciences Professor Sobouti Blvd., Karmandan Town., Gavazang Road Zanjan Zanjan Iran (Islamic Republic of)