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Flumazenil for Benzodiazepine Reversal in Electroconvulsive Therapy

RecruitingNAAges 18 Years - anyAllAnders Jørgensen
NCT07619092 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 t

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📋 Eligibility rules (as published)
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)
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What it tests

  • Flumazenil
  • Electroconvulsive therapy (ECT)
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Where

1 site
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Frederiksberg, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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