Flumazenil for Benzodiazepine Reversal in Electroconvulsive Therapy
Recruiting · NCT07619092 · Interventional (participants receive a specific treatment) · Lead sponsor: Anders Jørgensen
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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)
Where it is running
1 location listed.
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital - Frederiksberg, Capital Region, Denmark