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Study on Esketamine and Propofol for Anesthesia in Electroconvulsive Therapy for Patients with Major Depression

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 a combination of medications for patients with major depression undergoing a treatment called electroconvulsive therapy (ECT). The medications being studied are esketamine and propofol, which will be compared to another medication called methohexital. The purpose of the study is to see if the combination of esketamine and propofol is as effective and safe as methohexital when used during ECT.

Participants in the study will receive either the combination of esketamine and propofol or methohexital during their ECT sessions. The study will look at how well the medications help improve depressive symptoms and how quickly patients recover from anesthesia. The study will also monitor other factors such as blood pressure, heart rate, and any potential side effects on the liver and heart. The study will take place over a series of eight ECT sessions.

Throughout the study, researchers will assess various outcomes, including changes in cognitive function and the quality of the seizures induced by ECT. The study aims to ensure that the new combination of medications is not inferior to the current standard treatment with methohexital. Participants will be closely monitored to ensure their safety and well-being during the trial.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis of severe depression, and other health assessments.
A written informed consent document is signed after understanding the study details.
Step 2
Initial assessment
An initial assessment is conducted to establish a baseline for depressive symptoms using the Hamilton Depression Rating Scale (HAMD17).
Cognitive function is evaluated using a comprehensive test battery.
Step 3
Treatment sessions
The study involves a series of 8 electroconvulsive therapy (ECT) sessions.
Two treatment options are compared: esketamine plus propofol (referred to as ketofol) and methohexital anesthesia.
Esketamine is administered intravenously as a solution for injection, while propofol is given as an emulsion for injection or infusion.
Methohexital is provided as a solution for injection or infusion.
Step 4
Monitoring and evaluation
Throughout the sessions, changes in depressive symptoms are monitored using the HAMD17 scale.
Recovery time following anesthesia is recorded to compare the two treatment options.
Additional monitoring includes blood pressure, heart rate, and cognitive outcomes.
Step 5
Safety assessments
Safety assessments are conducted to monitor potential side effects, including liver function tests and cardiac markers.
These assessments occur at baseline, during the 4th session, and at the end of the treatment course.
Step 6
Final evaluation
After completing the 8 ECT sessions, a final evaluation of depressive symptoms and cognitive function is performed.
The results from both treatment groups are compared to determine the effectiveness and safety of the treatments.

Who can join the trial?

8 criteria

Must be a male or female patient staying in the hospital.
Must be at least 18 years old.
Must have a diagnosis of severe depression, either **unipolar** (one type of depression) or **bipolar** (depression with mood swings), according to the ICD-11 classification.
Must have a score of 24 or higher on the **Hamilton Depression Rating Scale (HAMD17)**, which is a questionnaire used to measure the severity of depression.
Must be able to understand and willing to sign a written consent form, which is a document that explains the study and confirms your agreement to participate.
Women must have a negative urine pregnancy test.
Must have approval from an anesthesiologist for **ECT (Electroconvulsive Therapy)**, with a health classification of 3 or lower according to the American Society of Anesthesiologists (ASA). This classification is a way to assess the physical health of patients before anesthesia.
Must have been taking antidepressant and antipsychotic medications consistently for at least 7 days before the first ECT treatment.

Who cannot join the trial?

7 criteria

Patients with any other serious mental health conditions besides major depression cannot participate. Major depression is a severe form of depression that affects how you feel, think, and handle daily activities.
Individuals who are not within the specified age range for the study are excluded. The study is open to adults only.
Participants who are not able to provide informed consent, meaning they cannot understand the study and agree to participate, are not eligible.
People with certain medical conditions that might interfere with the study or make it unsafe for them to participate are excluded.
Individuals who are currently participating in another clinical trial are not allowed to join this study.
Pregnant or breastfeeding women are not eligible to participate in the study.
Patients with a history of allergic reactions to the medications used in the study, such as esketamine or propofol, cannot participate. Esketamine is a medication used to treat depression, and propofol is a drug used to help patients relax before and during surgery.

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Verified sites

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Medical University Of Vienna
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Vienna, Austria

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Investigated drugs

Esketamine
is a medication used in this trial to help improve depressive symptoms. It is being tested in combination with another drug to see if it is as effective as a standard treatment for patients undergoing electroconvulsive therapy.
Propofol
is a medication used to induce and maintain anesthesia. In this trial, it is combined with esketamine to evaluate its effectiveness and safety compared to a traditional anesthetic during electroconvulsive therapy.
Methohexital
is a medication traditionally used to induce anesthesia. In this study, it serves as the standard treatment to which the combination of esketamine and propofol is being compared. The trial aims to see if the new combination is just as effective and safe as methohexital.

What is already known about the treatment

Esketamine
Esketamine is administered as a nasal spray and is currently being studied for its effectiveness in treating major depression, particularly in combination with propofol for electroconvulsive therapy. It is recognized in medical literature as a promising treatment for depression, especially in cases where other treatments have failed. Esketamine works by modulating the activity of glutamate, a neurotransmitter in the brain, which helps to restore synaptic connections in brain cells. It is classified as an NMDA receptor antagonist, which means it blocks certain receptors in the brain to produce its effects.
Propofol
Propofol is administered intravenously and is widely used as an anesthetic agent in various medical procedures, including electroconvulsive therapy. It is well-documented in medical literature for its rapid onset and short duration of action, making it suitable for procedures requiring quick recovery. Propofol works by enhancing the activity of GABA, a neurotransmitter that inhibits brain activity, leading to sedation and anesthesia. It is classified as a general anesthetic and is known for its ability to induce a calm and relaxed state in patients.
Methohexital
Methohexital is administered intravenously and is used as an anesthetic for short procedures, including electroconvulsive therapy. It is well-established in medical literature for its fast-acting properties and is often used when quick recovery from anesthesia is desired. Methohexital works by depressing the central nervous system, enhancing the effects of GABA, which leads to sedation and anesthesia. It is classified as a barbiturate anesthetic, known for its ability to induce sleep and relaxation quickly.

Investigated diseases

Major Depressive Disorder – This is a mental health condition characterized by persistent feelings of sadness, hopelessness, and a lack of interest or pleasure in activities. It can affect how a person feels, thinks, and handles daily activities, such as sleeping, eating, or working. The symptoms must be present for at least two weeks for a diagnosis to be made. The disorder can lead to a variety of emotional and physical problems and can decrease a person's ability to function at work and at home. It often involves episodes that can last for weeks or months, and these episodes can recur throughout a person's life. The severity and frequency of episodes can vary widely among individuals.