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

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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 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 a procedure called electroconvulsive therapy (ECT). ECT involves sending small electric currents through the brain to trigger a brief seizure, which can help improve symptoms of severe depression. The purpose of the study is to evaluate how effective this combination is in treating patients who have not responded to other antidepressant treatments.

Participants in the study will receive either the combination of ketamine and ECT or a standard treatment, which may include a placebo. The study will last for several weeks, during which participants will undergo regular assessments to monitor changes in their depressive symptoms. These assessments will help determine the short-term and long-term effects of the treatment. The primary focus will be on the change in symptoms from the start of the study to the end of the fourth week, using a scale called the Montgomery-Åsberg Depression Rating Scale (MADRS). This scale is commonly used to measure the severity of depression.

In addition to evaluating changes in depressive symptoms, the study will also look at how the treatment affects cognitive function, which includes mental processes like thinking, memory, and problem-solving. These cognitive assessments will be conducted at the end of the fourth week and again at the twelfth week to understand the broader impact of the treatment. The study aims to provide valuable insights into the potential benefits of combining ketamine with ECT for individuals with treatment-resistant depression.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a diagnosis of major depressive disorder.

    The assessment ensures that the participant has experienced treatment-resistant depression, defined as a lack of success with at least two different antidepressant medications.

  2. Step 2

    Baseline evaluation

    A baseline evaluation is performed to measure depressive symptoms using the Montgomery-Åsberg Depression Rating Scale (MADRS). This provides a starting point for assessing changes in symptoms.

  3. Step 3

    Treatment phase

    The treatment involves the administration of ketamine hydrochloride and sodium chloride through intravenous infusion. Ketamine is provided as a 50 mg/ml solution for injection, while sodium chloride is a 0.9% solution for infusion.

    The treatment is combined with electroconvulsive therapy (ECT) to evaluate its additive effect on depressive symptoms.

  4. Step 4

    Short-term evaluation

    After 28 days (Week 4), a short-term evaluation is conducted to measure changes in depressive symptoms using the MADRS. This assesses the immediate efficacy of the treatment.

  5. Step 5

    Long-term evaluation

    At Week 12, a long-term evaluation is performed to assess the sustained effects of the treatment on depressive symptoms. This includes another MADRS assessment.

    Cognitive outcomes are also evaluated at both Day 28 and Week 12 to determine the impact of the treatment on cognitive function.

Who can join the trial?

6 criteria

  • 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 who can have children must use at least one highly effective method of birth control. This includes options like an intrauterine device (IUD), surgical procedures to prevent pregnancy, hormonal birth control methods (like pills, patches, or injections), or using two forms of barrier protection (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**. This is a condition where a person feels very sad, hopeless, or loses interest in life for a long time. The diagnosis is made using a specific scale called the SCID5-CV.
  • The participant must have **treatment-resistant depression**. This means they have tried at least two different antidepressant medications, but these did not help.
  • The participant must have an adequate score for anesthesia. This means they are medically fit to receive anesthesia, which is a medicine that makes you sleep during certain medical procedures.

Who cannot join the trial?

9 criteria

  • Patients who do not have Major Depressive Disorder (MDD) cannot participate. MDD is a condition where a person feels very sad or loses interest in activities for a long time.
  • Patients who are not considered to have treatment-resistant depression are excluded. This means their depression has not improved after trying different treatments.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not willing to undergo electroconvulsive therapy (ECT) are excluded. ECT is a medical treatment that involves sending small electric currents through the brain to help improve symptoms of depression.
  • Patients who have medical conditions that make it unsafe to use ketamine are excluded. Ketamine is a medication sometimes used to help with depression.
  • Patients who are pregnant or breastfeeding cannot participate in the study.
  • Patients who have a history of substance abuse or addiction are excluded.
  • Patients who have certain other mental health disorders that could interfere with the study are excluded.
  • Patients who are unable to provide informed consent, meaning they cannot fully understand and agree to the study, are excluded.
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Investigated drugs

  • Ketamine

    is a medication that is being studied for its potential antidepressant effects. In this trial, it is used in combination with another therapy to see if it can help improve symptoms in patients with major depressive disorder who have not responded to other treatments.

  • Electroconvulsive Therapy (ECT)

    is a procedure where small electric currents are passed through the brain, intentionally triggering a brief seizure. ECT is used to treat severe depression and other mental health conditions, and in this study, it is combined with ketamine to evaluate their combined effect on depression.

What is already known about the treatment

Ketamine – Ketamine is administered intravenously and is being studied for its potential use in treating Major Depressive Disorder (MDD), particularly in patients who have not responded to other treatments. It is currently under investigation in clinical trials to assess its effectiveness when combined with electroconvulsive therapy (ECT). The main therapeutic indication for ketamine in this context is as an antidepressant for treatment-resistant depression. At the molecular level, ketamine works by blocking NMDA receptors in the brain, which are involved in mood regulation. It is classified pharmacologically as an anesthetic and has shown rapid antidepressant effects in some studies.

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 affects 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 vary in severity and may include physical symptoms such as changes in appetite or weight, difficulty sleeping, or a lack of energy. It can also lead to difficulties in concentration, decision-making, and may cause feelings of worthlessness or excessive guilt. The progression of the disorder can fluctuate, with periods of remission and recurrence.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512559-20-01Protocol codePRIN - 20227EA9ANEstimated enrolment30 patientsSponsorUniversita' Vita-salute S. Raffaele

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