Flumazenil to help reduce cognitive side effects during ECT for depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In adults with major depressive disorder or bipolar depression, participants receiving electroconvulsive therapy will be randomized to receive flumazenil to reverse benzodiazepine effects or a control during the ECT course. The primary outcome is the total SCIP score after the ECT series to measure cognitive function. Secondary outcomes include changes in pre-treatment anxiety, patient satisfaction, subjective memory complaints, autobiographical memory, and executive function. Randomization is stratified by age and electrode placement, with blinded outcome assessment for the primary endpoint. The study plans to enroll 145 participants to account for dropout, across two hospital sites in Denmark.

Why it matters

Who can join: the full rules

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's running

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
  Frederiksberg, Capital Region, Denmark Recruiting

Study contacts

• Principal investigator: Anders Jørgensen, MD, Ph.D. — Mental Health Services of the Capital Region
• Study coordinator: Stella K. S. Lystlund, MSc in Psychology
• Email: stella.klara.soerensdottir.lystlund@regionh.dk
• Phone: + 45 21 35 40 55

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.