Depression - Major Depressive DisorderFLEETNCT07619092
Flumazenil for Benzodiazepine Reversal in Electroconvulsive Therapy
A study testing Flumazenil and Electroconvulsive therapy (ECT) in people with Depression - Major Depressive Disorder and Bipolar Disorder (BD), run by Anders Jørgensen at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression - Major Depressive Disorder, Bipolar Disorder (BD), Functional Magnetic Resonance Imaging (fMRI)
- What is being tested?
- Flumazenil and Electroconvulsive therapy (ECT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Jan 2026to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Stella K. S. Lystlund, MSc in Psychology contact
Denmark1 site, 1 recruiting
- Recruiting
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Frederiksberg, Capital Region, 2000
About this study
Official title: Flumazenil for Benzodiazepine Reversal in Electroconvulsive Therapy (FLEET): A Randomized Controlled Trial
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).
Read more
Investigators will compare two different pre-ECT benzodiazepine management strategies:
- 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
- Benzodiazepine withholding strategy (treatment as usual): discontinuation of benzodiazepines and/or zopiclone prior to the ECT in accordance with standard clinical practice
Read the detailed description
The study will include adult inpatients (≥18 years of age) diagnosed with a mood disorder (major depressive disorder or bipolar disorder), currently experiencing a depressive episode (ICD-10: F31.3-5, F32 or F33), who are deemed eligible for ECT by a treating psychiatrist who is not affiliated with the study. Based on a power analysis, 132 participants (66 per group) are required to achieve adequate statistical power. To account for an anticipated 10% dropout rate from baseline to follow-up, the investigators will recruit 145 participants. Recruitment will be carried out through psychiatric hospital wards within the Mental Health Services of the Capital Region of Denmark.
Participants will be randomized following an initial screening to confirm eligibility. Randomization will be conducted using the automated randomization module in the Research Electronic Data Capture (REDCap) system, based on a pre-generated randomization list with variable block sizes of two and four. Allocation will be stratified by age (< 60 or ≥ 60 years) and electrode placement (unilateral vs. bilateral). Randomization will occur no later than the day prior to the second ECT session of the treatment series. Primary outcome assessors are blinded to the group allocation.
Baseline assessments will be conducted the day before the first ECT session or, if not otherwise possible, the day before the second ECT session. Participants will complete a brief neuropsychological assessment comprising the Screen for Cognitive Impairment in Psychiatry (SCIP) and additional measures of executive functioning and autobiographical memory. Participants will also complete self-report questionnaires assessing subjective cognitive complaints. Depressive symptom severity will be rated using the Hamilton Depression Rating Scale (HDRS).
During the ECT treatment series, repeated assessments will be conducted for each session. Participants will provide self-reported ratings of pre-treatment anxiety shortly before the session, while clinicians will record measures of seizure architecture, and time to reorientation following the session.
Follow-up assessments will be conducted 3-7 days after completion of the ECT-series, which serves as the primary end point. At follow-up, the brief neuropsychological assessment, self-report questionnaires, and HDRS ratings will be repeated. Participants will also complete a short self-report questionnaire of their treatment satisfaction. Structural and functional magnetic resonance imaging (MRI) is conducted within the 3-7 days after completion of the ECT series, coinciding with the follow-up assessment.
- Conditions
- Depression - Major Depressive Disorder, Bipolar Disorder (BD), Functional Magnetic Resonance Imaging (fMRI), Cognition, Autobiographical Memory, Electroconvulsive Therapy
- Being tested
- Flumazenil, Electroconvulsive therapy (ECT)
- Keywords
- flumazenil, benzodiazepine reversal, electroconvulsive therapy, randomized controlled trial, functional magnetic resonance imaging, Autobiographical Memory Test (AMT), Inpatients, Major Depressive Disorder, Bipolar Disorder, Treatment Outcome, Cognition
- Medical subject headings
- Bipolar Disorder, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlumazenilDrug
The intervention involves continuation of benzodiazepine and/or zopiclone treatment up to the time of ECT, followed by administration of flumazenil immediately prior to anesthesia to transiently reverse the effect of benzodiazepines and/or zopiclone. Otherwise, ECT is administered according to standard clinical procedures.
Electroconvulsive therapy (ECT)Procedure or surgery
Standard ECT treatment performed in accordance with clinical practice, with benzodiazepines and/or zopiclone withheld after 5:00 p.m. on the day before each session
| Study group | Role | What they receive |
|---|---|---|
| Flumazenil for benzodiazepine reversal | Experimental | Participants continue benzodiazepine and/or zopiclone treatment up until the ECT session, receiving flumazenil to reverse their effects Receives: Drug: Flumazenil |
| Treatment as usual (benzodiazepine hold) | Active comparator | Participants discontinue benzodiazepine and/or zopiclone treatment the day prior to the ECT session. Receives: Procedure: Electroconvulsive therapy (ECT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screen for Cognitive Impairment in Psychiatry (SCIP)
The primary outcome measure is the total score on the SCIP at follow-up (post-ECT). The SCIP is a brief neuropsychological assessment tool designed to detect cognitive deficits in individuals with psychotic and affective disorders. It comprises five subtests assessing key cognitive domains: verbal learning and memory (VLT-I and VLT-D), working memory (WMT), verbal fluency (VFT), and processing speed (PST). The total score provides a broad indicator of overall cognitive functioning. Higher scores mean a better outcome.
Measured: Baseline (the day before the first or second session in the ECT series) and follow-up (3-7 days after completion of the ECT series)
Secondary outcomes (19)
Hamilton Depression Rating Scale (HDRS)
Clinician-administered depression assessment scale of 17 items. Score range: 0-52. Clinical response at follow-up (primary endpoint) is assessed using the HAM-D6 subscale, collectively comprising the core symptoms of depression with score range: 0-22. Higher scores mean a worse outcome.
Measured: Baseline (the day before the first or second session in the ECT series) and follow-up (3-7 days after completion of the ECT series)
Cognitive Complaints in Bipolar Disorder Rating Scale (COBRA)
Self-report questionnaire assessing subjective cognitive complaints. Score range: 0-48. Higher scores mean a worse outcome.
Measured: Baseline (the day before the first or second session in the ECT series) and follow-up (3-7 days after completion of the ECT series)
Squire Subjective Memory Questionnaire (SSMQ)
Self-report questionnaire assessing subjective memory complaints. Score range: -72 - +72. Higher (more positive) scores mean a better outcome.
Measured: Baseline (the day before the first or second session in the ECT series) and follow-up (3-7 days after completion of the ECT series)
Autobiographical Memory Test (AMT)
Neuropsychological instrument used to assess the ability to retrieve autobiographical memories and their specificity. Higher scores mean a better outcome.
Measured: Baseline (the day before the first or second session in the ECT series) and follow-up (3-7 days after completion of the ECT series)
Trail Making Test B (TMT-B)
Neuropsychological test assessing executive function. Scored by time to completion. Higher scores mean a worse outcome.
Measured: Baseline (the day before the first or second session in the ECT series) and follow-up (3-7 days after completion of the ECT series)
Verbal learning and memory (VLT-I)
SCIP subtest assessing verbal learning and immediate recall. Score range: 0-30. Higher scores mean a better outcome.
Measured: Baseline (the day before the first or second session in the ECT series) and follow-up (3-7 days after completion of the ECT series)
Delayed verbal recall (VLT-D)
SCIP subtest assessing delayed verbal recall. Score range: 0-10. Higher scores mean a better outcome.
Measured: Baseline (the day before the first or second session in the ECT series) and follow-up (3-7 days after completion of the ECT series)
Working memory test (WMT)
SCIP subtest assessing working memory capacity. Score: 0-24. Higher scores mean a better outcome.
Measured: Baseline (the day before the first or second session in the ECT series) and follow-up (3-7 days after completion of the ECT series)
Verbal fluency test (VFT)
SCIP subtest assessing verbal fluency. No score range. Higher scores mean a better outcome.
Measured: Baseline (the day before the first or second session in the ECT series) and follow-up (3-7 days after completion of the ECT series)
Processing speed test (PST)
SCIP subtest assessing processing speed. Score range: 0-30. Higher scores mean a better outcome.
Measured: Baseline (the day before the first or second session in the ECT series) and follow-up (3-7 days after completion of the ECT series)
Patient Satisfaction Survey (PSS)
Self-report questionnaire assessing patient satisfaction following ECT treament. A subset of items are used. Higher scores mean a better outcome.
Measured: Follow-up (3-7 days after completion of the ECT series)
Visual Analogue Scale for Anxiety (VAS-A)
Visual analogue self-report scale assessing anxiety severity within the last 24 hours. Score range: 0-100. Higher scores mean a worse outcome.
Measured: Per ECT session
Time to reorientation
Clinician-administered structured interview measuring time to reorientation (in minutes) according to Sobin et al. (1995) and Stuiver et al. (2024). Patients are screened every 5 minutes after EEG-offset for orientation in five domains: name, location, age, date of birth, and day of the week. Reorientation is defined as the time in minutes from EEG-offset until the patient provides at least 4 out of 5 correct answers. If the patient fails to reach reorientation within 60 minutes, a score of 70 minutes is registered. Higher scores indicate a longer recovery period and a worse outcome.
Measured: Per ECT session
Seizure quality
Clinician-rated categorical EEG classification of seizure quality (A, A-T, T, O, S). A-seizures represent the optimal therapeutic pattern.
Measured: Per ECT session
Seizure length (EEG)
EEG seizure duration (seconds) from the end of stimulation to the last unequivocal ictal discharge. Continuous physiological measure.
Measured: Per ECT session
Stimulus dose
Stimulus dose recorded as the percentage of the device's maximum output (%) delivered during each treatment, as displayed on the ECT device readout. Range: 0-200%.
Measured: Per ECT session
Prefrontal and medial temporal activation during autobiographical memory retrieval
Functional magnetic resonance imaging (fMRI) measure of brain activity during an autobiographical memory test
Measured: Follow-up (3-7 days after completion of the ECT series)
Prefrontal, parietal and medial temporal activation during memory encoding
Functional magnetic resonance imaging (fMRI) measure of brain activity during a memory encoding task
Measured: Follow-up (3-7 days after completion of the ECT series)
Prefrontal and parietal activation during spatial N-back
Functional magnetic resonance imaging (fMRI) measure of brain activity during a working memory task
Measured: Follow-up (3-7 days after completion of the ECT series)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start15 Jan 2026
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anders Jørgensen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anders Jørgensen, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Investigators
- Anders Jørgensen, MD, Ph.D., Principal investigator, Mental Health Services of the Capital Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07619092
- Sponsor's protocol ID
- 2025-522506-20-00
- Other IDs
- 2025
- Acronym
- FLEET
- Status last verified
- May 2026
- First submitted
- 24 Sep 2025
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flumazenil for Benzodiazepine Reversal in Electroconvulsive Therapy (FLEET): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07619092
- Acronym / sponsor ID
- FLEET / 2025-522506-20-00
- Conditions
- Depression - Major Depressive Disorder, Bipolar Disorder (BD), Functional Magnetic Resonance Imaging (fMRI), Cognition, Autobiographical Memory, Electroconvulsive Therapy
- Keywords
- flumazenil, benzodiazepine reversal, electroconvulsive therapy, randomized controlled trial, functional magnetic resonance imaging, Autobiographical Memory Test (AMT), Inpatients, Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Anders JørgensenUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Benzodiazepine withholding strategy (treatment as usual): discontinuation of benzodiazepines and/or zopiclone prior to the ECT in accordance with standard clinical practice
Detailed description
The study will include adult inpatients (≥18 years of age) diagnosed with a mood disorder (major depressive disorder or bipolar disorder), currently experiencing a depressive episode (ICD-10: F31.3-5, F32 or F33), who are deemed eligible for ECT by a treating psychiatrist who is not affiliated with the study. Based on a power analysis, 132 participants (66 per group) are required to achieve adequate statistical power. To account for an anticipated 10% dropout rate from baseline to follow-up, the investigators will recruit 145 participants. Recruitment will be carried out through psychiatric hospital wards within the Mental Health Services of the Capital Region of Denmark.
Participants will be randomized following an initial screening to confirm eligibility. Randomization will be conducted using the automated randomization module in the Research Electronic Data Capture (REDCap) system, based on a pre-generated randomization list with variable block sizes of two and four. Allocation will be stratified by age (< 60 or ≥ 60 years) and electrode placement (unilateral vs. bilateral). Randomization will occur no later than the day prior to the second ECT session of the treatment series. Primary outcome assessors are blinded to the group allocation.
Baseline assessments will be conducted the day before the first ECT session or, if not otherwise possible, the day before the second ECT session. Participants will complete a brief neuropsychological assessment comprising the Screen for Cognitive Impairment in Psychiatry (SCIP) and additional measures of executive functioning and autobiographical memory. Participants will also complete self-report questionnaires assessing subjective cognitive complaints. Depressive symptom severity will be rated using the Hamilton Depression Rating Scale (HDRS).
During the ECT treatment series, repeated assessments will be conducted for each session. Participants will provide self-reported ratings of pre-treatment anxiety shortly before the session, while clinicians will record measures of seizure architecture, and time to reorientation following the session.
Follow-up assessments will be conducted 3-7 days after completion of the ECT-series, which serves as the primary end point. At follow-up, the brief neuropsychological assessment, self-report questionnaires, and HDRS ratings will be repeated. Participants will also complete a short self-report questionnaire of their treatment satisfaction. Structural and functional magnetic resonance imaging (MRI) is conducted within the 3-7 days after completion of the ECT series, coinciding with the follow-up assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flumazenil for benzodiazepine reversal | Experimental | Drug: FlumazenilParticipants continue benzodiazepine and/or zopiclone treatment up until the ECT session, receiving flumazenil to reverse their effects |
| Treatment as usual (benzodiazepine hold) | Active comparator | Procedure: Electroconvulsive therapy (ECT)Participants discontinue benzodiazepine and/or zopiclone treatment the day prior to the ECT session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FlumazenilThe intervention involves continuation of benzodiazepine and/or zopiclone treatment up to the time of ECT, followed by administration of flumazenil immediately prior to anesthesia to transiently reverse the effect of benzodiazepines and/or zopiclone. Otherwise, ECT is administered according to standard clinical procedures. | Drug | Flumazenil for benzodiazepine reversal |
| Electroconvulsive therapy (ECT)Standard ECT treatment performed in accordance with clinical practice, with benzodiazepines and/or zopiclone withheld after 5:00 p.m. on the day before each session | Procedure or surgery | Treatment as usual (benzodiazepine hold) |
Primary outcome
Screen for Cognitive Impairment in Psychiatry (SCIP)
Time frame: Baseline (the day before the first or second session in the ECT series) and follow-up (3-7 days after completion of the ECT series)
The primary outcome measure is the total score on the SCIP at follow-up (post-ECT). The SCIP is a brief neuropsychological assessment tool designed to detect cognitive deficits in individuals with psychotic and affective disorders. It comprises five subtests assessing key cognitive domains: verbal learning and memory (VLT-I and VLT-D), working memory (WMT), verbal fluency (VFT), and processing speed (PST). The total score provides a broad indicator of overall cognitive functioning. Higher scores mean a better outcome.
19 secondary outcomes
Hamilton Depression Rating Scale (HDRS)
Time frame: Baseline (the day before the first or second session in the ECT series) and follow-up (3-7 days after completion of the ECT series)
Cognitive Complaints in Bipolar Disorder Rating Scale (COBRA)
Time frame: Baseline (the day before the first or second session in the ECT series) and follow-up (3-7 days after completion of the ECT series)
Squire Subjective Memory Questionnaire (SSMQ)
Time frame: Baseline (the day before the first or second session in the ECT series) and follow-up (3-7 days after completion of the ECT series)
Autobiographical Memory Test (AMT)
Time frame: Baseline (the day before the first or second session in the ECT series) and follow-up (3-7 days after completion of the ECT series)
Trail Making Test B (TMT-B)
Time frame: Baseline (the day before the first or second session in the ECT series) and follow-up (3-7 days after completion of the ECT series)
Verbal learning and memory (VLT-I)
Time frame: Baseline (the day before the first or second session in the ECT series) and follow-up (3-7 days after completion of the ECT series)
Delayed verbal recall (VLT-D)
Time frame: Baseline (the day before the first or second session in the ECT series) and follow-up (3-7 days after completion of the ECT series)
Working memory test (WMT)
Time frame: Baseline (the day before the first or second session in the ECT series) and follow-up (3-7 days after completion of the ECT series)
Verbal fluency test (VFT)
Time frame: Baseline (the day before the first or second session in the ECT series) and follow-up (3-7 days after completion of the ECT series)
Processing speed test (PST)
Time frame: Baseline (the day before the first or second session in the ECT series) and follow-up (3-7 days after completion of the ECT series)
Patient Satisfaction Survey (PSS)
Time frame: Follow-up (3-7 days after completion of the ECT series)
Visual Analogue Scale for Anxiety (VAS-A)
Time frame: Per ECT session
Time to reorientation
Time frame: Per ECT session
Seizure quality
Time frame: Per ECT session
Seizure length (EEG)
Time frame: Per ECT session
Stimulus dose
Time frame: Per ECT session
Prefrontal and medial temporal activation during autobiographical memory retrieval
Time frame: Follow-up (3-7 days after completion of the ECT series)
Prefrontal, parietal and medial temporal activation during memory encoding
Time frame: Follow-up (3-7 days after completion of the ECT series)
Prefrontal and parietal activation during spatial N-back
Time frame: Follow-up (3-7 days after completion of the ECT series)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stella K. S. Lystlund, MSc in Psychology contact
Anders Jørgensen, MD, Ph.D. principal investigator
Mental Health Services of the Capital Region
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flumazenil and Electroconvulsive therapy (ECT) in people with Depression - Major Depressive Disorder and Bipolar Disorder (BD), run by Anders Jørgensen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stella K. S. Lystlund, MSc in Psychology (+ 45 21 35 40 55, stella.klara.soerensdottir.lystlund@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screen for Cognitive Impairment in Psychiatry (SCIP) (time frame: Baseline (the day before the first or second session in the ECT series) and follow-up (3-7 days after completion of the ECT series)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.