RecruitingNot Applicable

Flumazenil for Benzodiazepine Reversal in Electroconvulsive Therapy

Denmark145 participantsStarted 2026-01-15

Plain-language summary

The goal of this study is to investigate whether administering flumazenil to reverse the effects of benzodiazepines and/or zopiclone during electroconvulsive therapy (ECT) can help reduce cognitive side effects without diminishing treatment effectiveness in hospitalized patients with depression. The investigators hypothesize that blockade of the GABA receptor with flumazenil will reduce cognitive side effects through improved seizures and a reduced need for electrical charge escalation during the ECT series. Cognitive side effects will be measured by the total score on the Screening for Cognitive Impairment in Psychiatry (SCIP) (primary outcome) at follow-up after completion of the ECT series. Furthermore, it is expected that the flumazenil strategy will reduce pre-treatment anxiety and improve patient satisfaction (secondary outcomes). In addition, flumazenil strategy is hypothesized to have beneficial effects on subjective cognitive complaints, autobiographical memory, and executive functioning (secondary outcomes). Finally, the flumazenil strategy is expected to be associated with more favorable structural and functional changes in executive functioning and memory-related brain networks after completion of the ECT series, which may, in turn, be linked to better overall cognition and autobiographical memory (secondary outcome measures). For exploratory purposes, the study will also examine longitudinal changes in depressive symptoms and cognitive outcomes from baseline to follow-up (tertiary outcomes). Investigators will compare two different pre-ECT benzodiazepine management strategies: 1. Flumazenil strategy (experimental): continued benzodiazepine and/or zopiclone use up until the time of the ECT session, followed by administration of flumazenil immediately prior to ECT 2. Benzodiazepine withholding strategy (treatment as usual): discontinuation of benzodiazepines and/or zopiclone prior to the ECT in accordance with standard clinical practice

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: * Current depressive episode (unipolar or bipolar), corresponding to ICD-10 codes F31.3-5, F32 or F33. * Admitted at a study affiliated department in the Mental Health Services of the Capital Region of Denmark * Referred to ECT by the regular psychiatrist and has given consent to ECT * Currently receiving treatment with a benzodiazepine and/or zopiclone, at a minimum daily dose equivalent to 0.5 mg lorazepam. Exclusion criteria: * Involuntary treatment with ECT * Known gross abnormalities in brain structure deemed likely to influence cognitive functioning * Pregnancy or breast-feeding * Inability to read or understand Danish * Acute organic brain disease (e.g., delirium) influencing the ability to give informed consent * Any pre-existing condition associated with an increased risk of prolonged or uncontrollable seizures, including but not limited to epilepsy or alcohol- or benzodiazepine withdrawal states * Conditions associated with reduced metabolism of flumazenil (e.g., liver failure)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Screen for Cognitive Impairment in Psychiatry (SCIP)

Timeframe: Baseline (the day before the first or second session in the ECT series) and follow-up (3-7 days after completion of the ECT series)

Trial details

NCT IDNCT07619092

SponsorAnders Jørgensen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-08

Contact for this trial

Stella K. S. Lystlund, MSc in Psychology

+ 45 21 35 40 55 stella.klara.soerensdottir.lystlund@regionh.dk

View on ClinicalTrials.gov More Depression - Major Depressive Disorder trials