2025-522506-20-00RecruitingPhase 4
Flumazenil for Benzodiazepine Reversal in Electroconvulsive Therapy (FLEET): A Randomized Controlled Trial
Source: EU CTIS (euclinicaltrials.eu) · Last updated 9 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 145 (estimated)
- First submitted
- 27 May 2025
- Start date
- 7 Jan 2026
- Lead sponsor
- Region Hovedstaden
- Diseases
- Depression
- EU CT number
- 2025-522506-20-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 145
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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).
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Region Hovedstaden | Frederiksberg | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.