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Flumazenil for Benzodiazepine Reversal in Electroconvulsive Therapy (FLEET): A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Denmark
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
RECRUITING
Frederiksberg
Contact Information
Primary
Stella K. S. Lystlund, MSc in Psychology
stella.klara.soerensdottir.lystlund@regionh.dk
+ 45 21 35 40 55
Backup
Yunus Kiros, MD
yunus.kiros.02@regionh.dk
+ 45 81 71 95 29
Time Frame
Start Date: 2026-01-15
Estimated Completion Date: 2028-08
Participants
Target number of participants: 145
Treatments
Experimental: Flumazenil for benzodiazepine reversal
Participants continue benzodiazepine and/or zopiclone treatment up until the ECT session, receiving flumazenil to reverse their effects
Active_comparator: Treatment as usual (benzodiazepine hold)
Participants discontinue benzodiazepine and/or zopiclone treatment the day prior to the ECT session.
Related Therapeutic Areas
Sponsors
Leads: Anders Jørgensen

This content was sourced from clinicaltrials.gov