Study on the Effects of Ketamine and Electroconvulsive Therapy in Patients with Treatment-Resistant Major Depressive Disorder

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for Major Depressive Disorder (MDD), a condition characterized by persistent feelings of sadness and loss of interest. The study will explore the use of ketamine hydrochloride, a medication known for its rapid antidepressant effects, in combination with electroconvulsive stimulation (ECS), a procedure that uses electrical currents to influence brain activity. The goal is to understand how these treatments work together to help people with MDD who have not responded to other treatments.

Participants in the study will receive either the combination of ketamine and ECS or a placebo. The study will last for several weeks, during which participants will be monitored for changes in their depressive symptoms. The primary focus is to observe the short-term effects of the treatment over four weeks, with additional assessments to evaluate long-term effects and any impact on cognitive function, which refers to mental processes like thinking and memory.

The study aims to identify specific factors that determine how well patients respond to the treatment. This information could help tailor future treatments for individuals with treatment-resistant MDD, offering new hope for those who have not found relief with standard antidepressant medications. Participants will be closely monitored throughout the study to ensure their safety and well-being.

1 joining the study

Upon joining the study, you will be asked to provide informed consent, confirming your willingness to participate. This involves understanding the study’s purpose, procedures, and potential risks and benefits.

2 initial assessment

An initial assessment will be conducted to confirm your diagnosis of major depressive disorder (MDD) and to ensure that you meet the study’s inclusion criteria. This may involve interviews and questionnaires.

3 baseline measurement

Your depressive symptoms will be measured using the Montgomery-Åsberg Depression Rating Scale (MADRS). This will serve as a baseline to compare changes over time.

4 treatment phase

You will receive treatments involving ketamine hydrochloride and electroconvulsive stimulation (ECS). Ketamine will be administered as a solution for injection through an intravenous infusion. The specific dosage and frequency will be determined by the study protocol.

The treatment phase will last for 28 days, during which your response to the treatment will be closely monitored.

5 short-term evaluation

At the end of the 28-day treatment phase, your depressive symptoms will be reassessed using the MADRS to evaluate the short-term efficacy of the treatment.

6 extended observation

The study will continue to monitor your symptoms and cognitive function up to 12 weeks to assess the long-term effects of the treatment. Additional assessments will be conducted at the end of this period.

7 final assessment

A final assessment will be conducted to evaluate changes in your depressive symptoms and cognitive function. This will help determine the overall impact of the treatment.

Who Can Join the Study?

The participant must be willing and able to give informed consent to join the study. This means they understand the study and agree to take part.
Both men and women can participate, and they must be between the ages of 18 and 70.
Women of childbearing potential must use at least one highly effective method of birth control. This includes options like an intrauterine device (IUD), surgical procedures like tubal ligation, hormonal contraceptives (such as pills, patches, or injections), or using two barrier methods together (like a condom with spermicide). Choosing not to have heterosexual intercourse is also acceptable if it is the participant’s usual lifestyle.
The participant must have been diagnosed with major depressive disorder using a specific assessment tool called the SCID5-CV scale.
The participant must have treatment-resistant depression, which means they have tried at least two different antidepressant medications without success.
The participant must have an adequate score for anesthesia, which means they are medically fit to receive anesthesia if needed during the study.

Who Cannot Join the Study?

Patients who do not have a diagnosis of Major Depressive Disorder (MDD) cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not part of the specified clinical trial group cannot participate.
Patients who are not willing to undergo treatment with ketamine or electroconvulsive therapy (ECT) cannot participate.
Patients who are part of a vulnerable population that is not selected for this study cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Ospedale San Raffaele S.r.l.	Milan	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	01.09.2024

Trial locations

Investigated drugs:

Ketamine is a medication that is being studied for its potential to help people with major depressive disorder, especially those who have not responded to other treatments. In this trial, ketamine is used to see if it can improve the effects of another therapy called electroconvulsive therapy (ECT). Ketamine is known for its fast-acting properties and is being explored for its ability to quickly reduce symptoms of depression.

Electroconvulsive Therapy (ECT) is a treatment that involves sending small electrical currents through the brain. This is done to cause a brief seizure, which can lead to changes in brain chemistry that might help reduce symptoms of severe depression. In this study, ECT is used in combination with ketamine to see if the two together can provide better results for patients with major depressive disorder who have not found relief with other treatments.

Major Depressive Disorder (MDD) – Major Depressive Disorder is a mental health condition characterized by persistent feelings of sadness, hopelessness, and a lack of interest or pleasure in activities. 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 at work and in their personal lives. Symptoms may include changes in appetite or weight, sleep disturbances, fatigue, and difficulty concentrating. The progression of MDD can vary, with some individuals experiencing episodes that last for weeks or months, while others may have recurrent episodes throughout their lives. The severity and duration of symptoms can differ from person to person.

Trial ID:

2024-512559-20-00

Protocol code:

PRIN – 20227EA9AN

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Ketamine and Electroconvulsive Therapy in Patients with Treatment-Resistant Major Depressive Disorder

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?