Flumazenil for Benzodiazepine Reversal in Electroconvulsive Therapy (FLEET): A Randomized Controlled Trial
Key facts
- Where
- Frederiksberg, DániaSee the site
- Phase
- 4. fázis
Where in Dánia
- Region HovedstadenFrederiksberg, DániaTaking people
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?
Trial details
- Who runs it
- Region Hovedstaden
- Trial code
- EU 2025-522506-20-00
- Record updated
- 2025. szeptember 9.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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).
Exclusion: 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).