Actively Recruiting
Flumazenil for Benzodiazepine Reversal in Electroconvulsive Therapy A Randomized Controlled Trial
Led by Anders Jørgensen · Updated on 2026-06-01
145
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating whether giving flumazenil to reverse the effects of benzodiazepines and/or zopiclone during electroconvulsive therapy (ECT) can reduce cognitive side effects without lowering treatment effectiveness in hospitalized adults with depression. This study focuses on adults diagnosed with major depressive disorder or bipolar disorder currently experiencing a depressive episode and eligible for ECT. The goal is to see if blocking the GABA receptor with flumazenil improves seizures and reduces the need to increase electrical charge during the ECT series, potentially lessening cognitive impacts. Participants are randomly assigned to one of two groups: the experimental group continues benzodiazepine and/or zopiclone treatment up to the ECT session and then receives flumazenil just before anesthesia to reverse the drugs' effects; the comparison group follows usual care by stopping benzodiazepines and/or zopiclone the day before each ECT session. ECT is given according to standard clinical practices, with assessments conducted throughout the treatment series and after completion. Participants undergo baseline cognitive and mood assessments before the first or second ECT session, including tests of memory, executive function, and subjective cognitive complaints. During each ECT session, anxiety levels, seizure quality, and recovery times are recorded. Follow-up assessments occur 3 to 7 days after finishing ECT, repeating cognitive tests, depression ratings, and treatment satisfaction surveys. Brain imaging with MRI is also performed at follow-up to examine structural and functional changes related to memory and executive function. The primary outcome is cognitive function measured by the Screening for Cognitive Impairment in Psychiatry (SCIP).
CONDITIONS
Brief Title
Flumazenil for Benzodiazepine Reversal in Electroconvulsive Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Current depressive episode diagnosed as major depressive disorder or bipolar disorder (ICD-10: F31.3-5, F32, or F33)
- Admitted to a department affiliated with the Mental Health Services of the Capital Region of Denmark
- Referred for electroconvulsive therapy by a psychiatrist and consented to ECT
- Currently receiving benzodiazepine and/or zopiclone treatment at a daily dose equivalent to at least 0.5 mg lorazepam
You will not qualify if you...
- Receiving involuntary treatment with electroconvulsive therapy
- Known major brain abnormalities likely to affect cognitive function
- Pregnancy or breastfeeding
- Unable to read or understand Danish
- Acute organic brain disease affecting informed consent ability
- Pre-existing conditions increasing risk of prolonged or uncontrollable seizures (e.g., epilepsy or withdrawal states)
- Conditions reducing metabolism of flumazenil (e.g., liver failure)
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of the ECT treatment series
Participants undergo a series of electroconvulsive therapy (ECT) sessions. Those in the experimental group receive flumazenil immediately prior to anesthesia to reverse benzodiazepines and/or zopiclone effects. Participants in the comparator group discontinue benzodiazepine and/or zopiclone treatment the day prior to each ECT session. Repeated assessments occur during each ECT session including self-reported anxiety and clinician-recorded seizure measures and time to reorientation.
1 visit per ECT session
Duration - 3 to 7 days
Participants complete follow-up assessments 3-7 days after the completion of the ECT series, including neuropsychological tests, self-report questionnaires, depression rating scales, treatment satisfaction surveys, and MRI scans.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Frederiksberg, Capital Region, Denmark, 2000
Actively Recruiting
Research Team
S
Stella K. S. Lystlund, MSc in Psychology
Y
Yunus Kiros, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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