Overview
Sponsor-declared trial summary
Depression
To clarify if the FLZ reversal strategy leads to a reduction in cognitive side-effects without losing clinical efficacy, and whether it is associated with neurobiological changes in brain memory networks.
Key facts
- Sponsor
- Region Hovedstaden
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 7 Jan 2026 → ongoing
- Decision date (initial)
- 2025-09-09
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Lundbeck Foundation
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Therapy
To clarify if the FLZ reversal strategy leads to a reduction in cognitive side-effects without losing clinical efficacy, and whether it is associated with neurobiological changes in brain memory networks.
Conditions and MedDRA coding
Depression
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1) Patients with depression (unipolar or bipolar, ICD-10 codes F31.3-5, F32, F33); 2) admitted at a study affiliated department in the Mental Health Services of the Capital Region of Denmark; 3) who have been referred for ECT by their regular psychiatrist and have given informed consent to ECT, and 4) who are in treatment with a benzodiazepine (minimum of 0.5 lorazepam equivalents daily).
Exclusion criteria 1
- 1) involuntary treatment; 2) known gross abnormalities in brain structure or 3) Pregnancy or breast-feeding, 4) unable to read and understand Danish, 4) any preexisting condition associated with an increased risk for prolonged or uncontrollable seizures, including, but not restricted to, epilepsy and alcohol- or benzodiazepine withdrawal states, 5) conditions associated with a reduced metabolism of flumazenil (e.g., liver failure).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Objective cognitive function
Secondary endpoints 10
- Clinical response
- Subjective cognitive performance
- Autobiographical memory function
- Executive cognitive function
- Separate cognitive domains
- Patient satisfaction
- Pre-treatment anxiety
- Reorientation time
- Seizure quality
- Brain memory networks
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP114893165 · ATC
- Active substance
- Flumazenil
- Route of administration
- INJECTION
- Max daily dose
- 1.00 mg milligram(s)
- Max total dose
- 100 mg milligram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- V03AB25 — FLUMAZENIL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Hovedstaden
- Sponsor organisation
- Region Hovedstaden
- Address
- Nordre Fasanvej 57, 1st Floor Entrance 2 1st Floor Entrance 2
- City
- Frederiksberg
- Postcode
- 2000
- Country
- Denmark
Scientific contact point
- Organisation
- Region Hovedstaden
- Contact name
- Region Hovedstadens Psykiatri
Public contact point
- Organisation
- Region Hovedstaden
- Contact name
- Region Hovedstadens Psykiatri
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| GCP unit at University of Copenhagen ORL-000005038
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 145 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2026-01-07 | 2026-01-07 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | COBRA-Danish | 1 |
| Protocol (for publication) | FLEET_protocol_forpub_rev2 | 3 |
| Protocol (for publication) | Squire_Subjective_Memory_Questionnaire | 1 |
| Protocol (for publication) | Tilfredshed med ECT | 1 |
| Protocol (for publication) | VAS-A | 1 |
| Recruitment arrangements (for publication) | informedconsent_patientrecruitmentprocedure_en_rev1 | 2 |
| Subject information and informed consent form (for publication) | Dine rettigheder som forsgsperson i forsg med medicin _ De Videnskabsetiske Komiteer | 1 |
| Subject information and informed consent form (for publication) | FLEET_samtykke | 1 |
| Subject information and informed consent form (for publication) | Tillg til samtykkeblanket - Retten til ikke-viden | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Flumazenil - Summary of Product Characteristics | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-05-27 | Denmark | Acceptable 2025-09-03
|
2025-09-09 |