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Study on Thiopental Sodium Dose During Electroconvulsive Therapy for Patients with Major Depressive Disorder

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of different doses of the anesthetic medication thiopental sodium during electroconvulsive therapy (ECT) for patients with major depressive disorder. Major depressive disorder, often referred to as depression, is a mental health condition characterized by persistent feelings of sadness and loss of interest. The trial aims to determine if using a lower dose of thiopental sodium during ECT can lead to a greater reduction in depressive symptoms compared to a higher dose.

Participants in the study will undergo six sessions of ECT, a treatment that involves sending small electric currents through the brain to trigger a brief seizure, which can help alleviate symptoms of depression. The study will compare the effects of a low dose versus a high dose of thiopental sodium on the reduction of depressive symptoms. Additionally, the study will observe other factors such as the duration of seizures, cognitive side effects, the total number of ECT sessions needed, length of hospital stay, awareness during anesthesia, and the risk of depression returning within a year after treatment.

The purpose of this study is to explore whether adjusting the dose of thiopental sodium can improve the outcomes of ECT for patients with major depressive disorder. The trial will provide valuable insights into optimizing ECT treatment to enhance its effectiveness and minimize potential side effects for individuals suffering from depression.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, you will be informed about the study's purpose and procedures. You will be asked to provide consent to participate in the trial, acknowledging that you understand the information provided.
Step 2
Initial assessment
An initial assessment will be conducted to evaluate your current health status and confirm your eligibility. This may include a review of your medical history and a physical examination.
Step 3
Randomization
You will be randomly assigned to one of two groups. One group will receive a low dose of the anesthetic medication thiopental sodium, and the other group will receive a high dose. This process ensures that the study results are unbiased.
Step 4
Treatment sessions
You will undergo a series of six electroconvulsive therapy (ECT) sessions. During each session, you will receive the assigned dose of thiopental sodium through an intravenous injection. The sessions are designed to help reduce symptoms of major depressive disorder.
Step 5
Monitoring and evaluation
Throughout the trial, your health and response to the treatment will be closely monitored. This includes measuring changes in your depression symptoms using a scale called the Montgomery-Åsberg Depression Rating Scale (MADRS).
Step 6
Follow-up assessments
After completing the ECT sessions, follow-up assessments will be conducted to evaluate any cognitive side effects and the overall effectiveness of the treatment. These assessments will occur within a week after the last ECT session and again after six months.
Step 7
Completion of trial
Upon completing all required assessments, your participation in the trial will conclude. The information gathered will contribute to understanding the effects of different anesthetic doses during ECT for major depression.

Who can join the trial?

3 criteria

Must be 18 years or older.
Must be a hospitalized patient currently experiencing a major depressive episode.
Both men and women can participate.

Who cannot join the trial?

4 criteria

Patients who do not have major depressive disorder cannot participate. This is a condition where a person feels very sad, hopeless, and loses interest in activities for a long time.
Patients who are not within the age range of 18 to 65 years old cannot participate.
Patients who are not able to undergo electroconvulsive therapy (ECT) cannot participate. ECT is a medical treatment where small electric currents are passed through the brain to help improve symptoms of certain mental health conditions.
Patients who cannot be anesthetized with thiopental cannot participate. Thiopental is a medication used to make patients sleep during medical procedures.

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Verified sites

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Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen
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Gothenburg, Sweden

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Investigated drugs

Thiopental is a medication used to help patients relax and fall asleep before undergoing a medical procedure. In this trial, it is used to help patients relax before receiving electroconvulsive therapy (ECT) for depression. The study is looking at how different amounts of thiopental might affect the results of the ECT treatment for depression. By comparing the effects of lower and higher amounts of thiopental, researchers hope to find out which amount helps improve depression symptoms more effectively after several ECT sessions.

Thiopental Sodium

What is already known about the treatment

Thiopental – Thiopental is administered intravenously, meaning it is given through a vein, typically as part of the anesthesia process during medical procedures. In the context of the TIDE clinical trial, thiopental is being studied for its effects when used in different doses during electroconvulsive therapy (ECT) for patients with major depressive disorder. The main therapeutic indication for thiopental in this trial is to assess its impact on reducing depressive symptoms. At the molecular level, thiopental works by enhancing the activity of a neurotransmitter called GABA, which helps to calm the brain and nervous system. It is classified pharmacologically as a barbiturate, a type of drug that acts as a central nervous system depressant.

Investigated diseases

Major depressive disorder – Major depressive disorder is a mental health condition characterized by persistent and intense feelings of sadness and a lack of interest in activities once enjoyed. It affects how a person feels, thinks, and handles daily activities, such as sleeping, eating, or working. The disorder can lead to a variety of emotional and physical problems, making it difficult for individuals to function in their daily lives. Symptoms may include changes in appetite or weight, sleep disturbances, fatigue, feelings of worthlessness or guilt, difficulty concentrating, and recurrent thoughts of death or suicide. The progression of the disorder can vary, with some individuals experiencing episodes that last for weeks or months, while others may have symptoms that persist for years. The severity and duration of symptoms can fluctuate over time, often influenced by stress or other life events.