Taking people in DenmarkPhase 4
Testing flumazenil to reverse sedation during electroconvulsive therapy for depression
Tests flumazenil, given to reverse a sedative, in adults receiving electroconvulsive therapy for depression.
Key facts
- Who runs it
- Region Hovedstaden
- Where
- Frederiksberg, DenmarkSee the site
- Trial code
- Registry title
- Flumazenil for Benzodiazepine Reversal in Electroconvulsive Therapy (FLEET): A Randomized Controlled Trial
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 145 people, planned
- Started
- 7 Jan 2026
- Expected to end
- 1 Oct 2028
- Type of study
- Interventional
- Record updated
- 9 September 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with depression who are referred for electroconvulsive therapy (ECT) and already take a benzodiazepine every day.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Depression, either unipolar or bipolar (ICD-10 codes F31.3-5, F32, F33), admitted to a study department in the Mental Health Services of the Capital Region of Denmark
- Earlier treatment
- Must be referred for ECT by their regular psychiatrist and have agreed to it. Must take a benzodiazepine (at least 0.5 lorazepam equivalents daily).
Main reasons for not taking part
- Involuntary treatment
- Known gross abnormalities in brain structure
- Pregnancy or breast-feeding
- Cannot read and understand Danish
- Conditions that raise the risk of long or uncontrollable seizures, such as epilepsy or alcohol or benzodiazepine withdrawal
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- Patients with depression (unipolar or bipolar, ICD-10 codes F31.3-5, F32, F33); 2) admitted at a study affiliated department in the Mental Health Services of the Capital Region of Denmark; 3) who have been referred for ECT by their regular psychiatrist and have given informed consent to ECT, and 4) who are in treatment with a benzodiazepine (minimum of 0.5 lorazepam equivalents daily)
Who cannot take part
- involuntary treatment; 2) known gross abnormalities in brain structure or 3) Pregnancy or breast-feeding, 4) unable to read and understand Danish, 4) any preexisting condition associated with an increased risk for prolonged or uncontrollable seizures, including, but not restricted to, epilepsy and alcohol- or benzodiazepine withdrawal states, 5) conditions associated with a reduced metabolism of flumazenil (e.g., liver failure)
Where in Denmark
- Region HovedstadenFrederiksberg, DenmarkTaking people
About the trial
What the trial wants to find out
To clarify if the FLZ reversal strategy leads to a reduction in cognitive side-effects without losing clinical efficacy, and whether it is associated with neurobiological changes in brain memory networks.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- Flumazenil for Benzodiazepine Reversal in Electroconvulsive Therapy (FLEET): A Randomized Controlled Trial
- Plain-language title
- Testing flumazenil to reverse sedation during electroconvulsive therapy for depressionGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 9 September 2025