Clinical trial • Not applicable • Psychiatry

FLUMAZENIL for Major depressive disorder|Bipolar depression

Not applicable trial of FLUMAZENIL for Major depressive disorder|Bipolar depression. Randomised. 145 participants.

Overview

Trial Therapeutic Area
Psychiatry
Trial Disease
Major depressive disorder|Bipolar depression
Trial Stage
Not applicable
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
27-05-2025
First CTIS Authorization Date
09-09-2025

Trial design

Randomised Not applicable trial across 1 site in Denmark.

Randomised
Yes
Target Sample Size
145

Eligibility

Recruits 145 Vulnerable population not selected. Participants must have given informed consent to ECT; subject information and informed consent form documents are provided for participants. No assent or parental consent procedures specified..

Pregnancy Exclusion
3) Pregnancy or breast-feeding,
Vulnerable Population
Vulnerable population not selected. Participants must have given informed consent to ECT; subject information and informed consent form documents are provided for participants. No assent or parental consent procedures specified.

Inclusion criteria

  • {"criterion_text":"- 1) Patients with depression (unipolar or bipolar, ICD-10 codes F31.3-5, F32, F33);\n- 2) admitted at a study affiliated department in the Mental Health Services of the Capital Region of Denmark;\n- 3) who have been referred for ECT by their regular psychiatrist and have given informed consent to ECT, and\n- 4) who are in treatment with a benzodiazepine (minimum of 0.5 lorazepam equivalents daily)."}

Exclusion criteria

  • {"criterion_text":"- 1) involuntary treatment;\n- 2) known gross abnormalities in brain structure or\n- 3) Pregnancy or breast-feeding,\n- 4) unable to read and understand Danish,\n- 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,\n- 5) conditions associated with a reduced metabolism of flumazenil (e.g., liver failure)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Objective cognitive function","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Clinical response","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Subjective cognitive performance","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Autobiographical memory function","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Executive cognitive function","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Separate cognitive domains","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Patient satisfaction","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Pre-treatment anxiety","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Reorientation time","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Seizure quality","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Brain memory networks","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
145
Recruitment Window Months
36
Consent Approach
Informed consent required from participants (adult patients). Subject information and informed consent form documents are provided (documents include 'informedconsent_patientrecruitmentprocedure_en_rev1' and 'FLEET_samtykke'). Participants must have given informed consent to ECT prior to inclusion. No assent/parental consent procedures specified.

Methods

  • Recruitment from patients admitted to study-affiliated departments in the Mental Health Services of the Capital Region of Denmark; patients referred for ECT by their regular psychiatrist are eligible and recruited from clinical services in Denmark.

Geography

Total Number Of Sites
1
Total Number Of Participants
145

Denmark

Earliest CTIS Part Ii Submission Date
29-08-2025
Latest Decision Or Authorization Date
09-09-2025
Processing Time Days
11
Number Of Sites
1
Number Of Participants
145

Sites

Site Name
Region Hovedstaden
Department Name
Psychiatric Center Copenhagen
Principal Investigator Name
Anders Jorgensen
Principal Investigator Email
anders.01.joergensen@regionh.dk
Contact Person Name
Anders Jorgensen
Number Of Participants
145

Sponsor

Primary sponsor

Full Name
Region Hovedstaden
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

Third parties

  • {"country":"Denmark","full_name":"GCP unit at University of Copenhagen","duties_or_roles":"1","organisation_type":"Educational Institution"}

Investigational products

Investigational Product Name
FLUMAZENIL
Active Substance
FLUMAZENIL
Modality
Small molecule
Routes Of Administration
INJECTION
Route
INJECTION
Authorisation Status
prodAuthStatus:2; marketingAuthNumber:-
Maximum Dose
maxDailyDoseAmount: 1.00 mg; maxTotalDoseAmount: 100 mg

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