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New treatment option for Depression - Major Depressive Disorder
Official title Flumazenil for Benzodiazepine Reversal in Electroconvulsive Therapy
ClinicalTrials.gov ID: NCT07619092
What this study is testing
What is Flumazenil?
Flumazenil is an investigational medicine, being studied as a potential treatment for depression - major depressive disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
See the full eligibility 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.
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Frederiksberg, Capital Region, Denmark
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Frederiksberg, Capital Region, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.