Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study of Flumazenil to Reduce Side Effects of Electroconvulsive Therapy in Patients with Depression

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This study focuses on patients with depression, including both unipolar and bipolar types, who are receiving electroconvulsive therapy (ECT) and are currently taking medications called benzodiazepines. The research examines the use of a medication called flumazenil, which is designed to reverse the effects of benzodiazepines during ECT treatment.

The purpose of this research is to determine if using flumazenil can reduce memory and thinking-related side effects that can occur with ECT treatment, while still maintaining its effectiveness in treating depression. The study will also look at how this approach affects the brain's memory networks. During the study, participants will receive either flumazenil or a placebo through an injection before their ECT sessions.

Throughout the study period, which lasts up to three months, various aspects will be monitored, including memory function, thinking abilities, and how well the treatment works for depression symptoms. The research will also assess how quickly patients recover after each treatment session and their overall satisfaction with the procedure.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Your participation begins after being diagnosed with depression and receiving a referral for ECT (Electroconvulsive Therapy) from your psychiatrist

    You must be currently taking benzodiazepine medication (minimum daily dose equivalent to 0.5 mg of lorazepam)

  2. Step 2

    Treatment preparation

    Your treatment will involve ECT sessions combined with Flumazenil administration

    Flumazenil will be given through an injection

    The study focuses on examining how this combination affects your memory and thinking abilities

  3. Step 3

    Monitoring and assessment

    Your cognitive function will be evaluated through specific tests

    Your memory performance will be assessed, including autobiographical memory (personal life events) and executive function (planning and decision-making abilities)

    Your satisfaction with the treatment will be recorded

    The medical team will monitor your anxiety levels before treatment

    The time it takes for you to regain full awareness after each session will be measured

    Brain activity related to memory will be evaluated

  4. Step 4

    Study duration

    The study period runs from October 2025 to October 2028

    Your individual participation duration will be determined by your treatment needs

Who can join the trial?

8 criteria

  • You must be diagnosed with depression (either unipolar or bipolar type)
  • You must be between 18 and 64 years old
  • Both men and women can participate
  • You must be currently receiving care at one of the participating mental health departments
  • Your regular psychiatrist must have recommended ECT (Electroconvulsive Therapy) as part of your treatment
  • You must have provided informed consent to receive ECT treatment
  • You must be currently taking benzodiazepine medication (a type of medication that helps reduce anxiety) at a daily dose equivalent to at least 0.5 mg of lorazepam
  • You must not be part of any vulnerable population groups

Who cannot join the trial?

14 criteria

  • Age below 18 or above 65 years
  • Current diagnosis of bipolar disorder (a condition with alternating periods of depression and elevated mood)
  • History of psychotic disorders (conditions that affect the mind, causing loss of contact with reality)
  • Current substance abuse or dependence within the past 6 months
  • Serious or unstable medical conditions that could interfere with treatment
  • Current pregnancy or breastfeeding
  • Previous unsuccessful treatment with the study medication
  • Participation in another clinical trial within the past 30 days
  • Presence of suicidal ideation (thoughts about suicide) with immediate risk
  • Known allergies or hypersensitivity to the study medication
  • Severe liver or kidney problems
  • Use of medications that could interact with the study drug
  • Inability to provide informed consent
  • Cognitive impairment that would interfere with study assessments
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Flumazenil

    is a medication that works by reversing the effects of benzodiazepines (a type of sedative medication). It acts like an antidote to these sedatives by blocking their action in the brain. In this trial, it is being studied to see if it can help reduce memory and thinking problems that sometimes occur after electroconvulsive therapy.

  • Electroconvulsive Therapy (ECT)

    is a medical treatment that uses controlled electrical currents to trigger a brief seizure in the brain while the patient is under anesthesia. It is used to treat severe depression and some other mental health conditions. The therapy is carefully monitored and performed in a medical setting by trained healthcare professionals.

What is already known about the treatment

Flumazenil - A competitive antagonist medication administered intravenously that specifically blocks benzodiazepine receptors in the brain. It is primarily used to reverse the sedative and respiratory depressant effects of benzodiazepines during medical procedures, including electroconvulsive therapy. The medication works by binding to GABA receptors and preventing benzodiazepines from attaching to these sites, effectively neutralizing their effects. This rapid-acting drug belongs to the class of benzodiazepine antagonists and is particularly valuable in clinical settings where quick reversal of benzodiazepine-induced sedation is needed, while potentially helping to reduce cognitive side effects of certain treatments.

Investigated diseases

Depression - A mental health condition characterized by persistent feelings of sadness, loss of interest in activities, and decreased energy levels. Depression affects how a person thinks, feels, and handles daily activities, often causing changes in sleep patterns, appetite, and concentration. The condition can develop gradually and may involve physical symptoms such as unexplained aches and pains. Depression can affect people of all ages and backgrounds, impacting both emotional and physical well-being. The condition may fluctuate in intensity over time, with periods of more severe symptoms alternating with periods of improvement.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522506-20-00Estimated enrolment145 patientsSponsorRegion Hovedstaden

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.