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Flumazenil for Benzodiazepine Reversal in Electroconvulsive Therapy (FLEET): A Randomized Controlled Trial
EU CTIS ID: 2025-522506-20-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1) 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).
You likely can't join if
- 1) 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).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.