Evaluation of Thiopental Sodium Dosing in Electroconvulsive Therapy for Major Depressive Disorder: A Randomized Controlled Trial

The primary objective of this randomized controlled trial is to evaluate whether the reduction of depressive symptoms after six **electroconvulsive therapy** (ECT) sessions is greater in patients anesthetized with a low dose of **thiopental sodium** compared to those receiving a high dose during ECT. This is clinically relevant as optimizing the anesthetic dose could enhance the therapeutic efficacy of ECT in treating **major depressive disorder**.

Secondary objectives include assessing whether seizure duration differs between the low and high thiopental dose groups, and if there are significant differences in cognitive side effects experienced within a week after ECT, as well as their persistence after six months. The study also aims to determine if there are differences in the total number of ECT sessions required, the duration of hospital stay, the occurrence of awareness during anesthesia, and the risk of **major depressive disorder** relapse within a year between the two dose groups.

The clinical trial involves participants diagnosed with **major depressive disorder**. The study population includes both male and female subjects aged 18 years and above, who are currently hospitalized due to an ongoing major depressive episode. The sponsor has not provided information regarding the total number of participants. The trial population was selected based on specific inclusion criteria, focusing on adults experiencing significant depressive symptoms. Participants' general health status is characterized by their current hospitalization for depression, and no vulnerable populations are included in this study. Lifestyle considerations such as diet, physical activity, or habits are not specified in the available data.

The clinical trial is designed to evaluate the effect of **thiopental sodium** dose during electroconvulsive therapy (ECT) for patients with **major depressive disorder**. This is a randomized, controlled trial with a double-blind design to ensure unbiased results. The trial aims to determine if a low dose of thiopental sodium results in a greater reduction of depressive symptoms compared to a high dose after six ECT sessions. The primary endpoint is the change in the Montgomery-Åsberg Depression Rating Scale (MADRS) score, while secondary endpoints include seizure duration, cognitive side effects, total number of ECT sessions, length of hospital stay, awareness during anesthesia, and risk of relapse within a year.

The trial is expected to commence recruitment on January 13, 2025, and conclude by December 31, 2031. Participants will be involved for a maximum treatment period of three weeks, with the possibility of early termination if adverse effects occur or if the participant withdraws consent. The study includes an initial screening visit to confirm eligibility, based on criteria such as age (18 years and above) and hospitalization due to an ongoing major depressive episode. Follow-up visits will be scheduled to monitor the participants' response to treatment and any side effects. The end-of-study visit will assess the final outcomes and gather data on the primary and secondary endpoints.

The clinical trial involves the administration of **Pentocur**, a pharmaceutical product containing the active substance **thiopental sodium**. This medication is provided in the form of a powder for solution for injection, specifically designed for intravenous administration. The trial aims to evaluate the effect of different doses of thiopental sodium during electroconvulsive therapy (ECT) for major depression. The maximum daily dose of thiopental sodium is 5.50 mg/kg, with a total maximum dose of 6.00 grams over the course of the treatment. The treatment period is limited to a maximum of three days. The product is manufactured by ABCUR AB and is not a pediatric formulation.

In this study, no non-experimental treatments such as standard-of-care therapy, placebo, or comparator treatments are utilized. The focus is solely on the administration of thiopental sodium to assess its efficacy in reducing depressive symptoms during ECT. Participant compliance with the dosing schedule is monitored to ensure adherence to the protocol. The trial does not involve any additional medications or interventions beyond the specified use of thiopental sodium.

Efficacy in this clinical trial will be assessed by evaluating the reduction of depressive symptoms in patients undergoing electroconvulsive therapy (ECT) for major depressive disorder (MDD). The primary endpoint for efficacy is the change in the Montgomery-Åsberg Depression Rating Scale (MADRS) score after six ECT sessions, comparing patients anesthetized with a low dose of **thiopental sodium** to those receiving a high dose. This assessment will determine if the low thiopental dose results in a greater reduction of depressive symptoms.

Secondary endpoints include several parameters: seizure duration, cognitive side effects within a week after ECT and after six months, the total number of ECT sessions required, length of hospital stay, awareness during anesthesia, and the risk of MDD relapse within a year post-ECT. These endpoints will be measured and analyzed to provide a comprehensive evaluation of the efficacy and safety of the thiopental dosing strategy during ECT. The trial is designed to ensure that data collection and analysis are conducted systematically, adhering to the trial's protocol and timeline.