KETAMINE HYDROCHLORIDE for Major depressive disorder | Treatment-resistant depression

Inclusion criteria

• {"criterion_text":"- ●\tAre fluent in spoken and written Norwegian."}
• {"criterion_text":"- ●\tAble to provide informed consent to participate in the current study. This may include involuntarily hospitalized patients"}
• {"criterion_text":"- ●\tMale or female adults aged 18 years or older"}
• {"criterion_text":"- ●\tMeet DSM-5 criteria for MDD or bipolar-2 disorder as assessed by the MINI version 7.0.2"}
• {"criterion_text":"- ●\tHave a current MDE of at least moderate severity defined by a Montgomery-Åsberg Depression Rating Scale (MADRS) score of ≥ 20"}
• {"criterion_text":"- ●\tMeet criteria for treatment-resistant depression, defined by previous treatment for depression included a minimum of two evidence-based treatments (psychopharmacology, psychotherapy, ECT/TMS) without adequate response, in accordance with Canadian Network for Mood and Anxiety Treatments (CANMAT) guidelines for the management of unipolar or bipolar depression"}
• {"criterion_text":"- ●\tWomen of childbearing potential (WOCBP) as defined in Section 10.4.1 must have a negative pregnancy test at study entry and prior to maintenance ketamine infusion and must agree to use adequate birth control through the last ketamine infusion."}
• {"criterion_text":"- • Only highly effective contraception methods are permitted in this trial. See Section 10.6.2 Contraception guidelines for a list of these methods."}

Exclusion criteria

• {"criterion_text":"- ●\tWomen who intend to become pregnant or are breast-feeding"}
• {"criterion_text":"- ●\tOngoing or previous manic episodes"}
• {"criterion_text":"- ●\tHistory of any psychotic or bipolar type 1 disorder as assessed by the Mini International Neuropsychiatric Interview (MINI v. 7.0.2)"}
• {"criterion_text":"- ●\tHistory of severe personality disorder, severe dissociative disorder, severe obsessive-compulsive disorder, autism-spectrum disorder, or other mental comorbidities, assessed by the MINI and/or Structured Clinical Interview for DSM Disorders (SCID), that may interfere with the interpretation of the study results or pose a health risk to the participant per investigator’s judgement"}
• {"criterion_text":"- ●\tCurrent eating disorder with active purging as assessed by MINI"}
• {"criterion_text":"- ●\tCurrent severe substance/alcohol use disorder (per DSM-5 criteria) and substance/alcohol use that, in the investigator’s judgment, may compromise participant safety, study integrity, or compliance with study procedures"}
• {"criterion_text":"- ●\tCardiovascular conditions: Heart failure (NYHA class III or IV), recent stroke (< 1 year from enrollment), recent myocardial infarction (< 1 year from enrollment), uncontrolled hypertension (>160/100 mm Hg) or recent clinically significant arrhythmia (< 1 year from enrolment)"}
• {"criterion_text":"- ●\tLiver failure (Child-Pugh Class C) or impairment of liver function as assessed by medical history, clinical examination and laboratory results at screening (i.e. INR > 1,2 or bilirubin > 30 μmol/L)"}
• {"criterion_text":"- ●\tKidney failure (creatinine clearance < 30 mL/min by Cockcroft-Gault)"}
• {"criterion_text":"- ●\tChronic respiratory failure (requiring LTOT and/or GOLD 3 (severe) or higher)"}
• {"criterion_text":"- ●\tObstructive or central sleep apnoea requiring treatment with oxygen, CPAP/BiPAP"}
• {"criterion_text":"- ●\tPregnant women as assessed by blood HCG tests"}
• {"criterion_text":"- ●\tGlaucoma or globe injury"}
• {"criterion_text":"- ●\tPrevious anaphylactic reaction to ketamine"}
• {"criterion_text":"- ●\tUncontrolled hypo- or hyperthyroidism"}
• {"criterion_text":"- ●\tCurrent or suspected increased intracranial pressure"}
• {"criterion_text":"- ●\tAcute intermittent porphyria"}
• {"criterion_text":"- ●\tAny other severe medical or neurological condition that, in the investigator’s judgement, may interfere with the interpretation of the study results or pose a health risk to the participant."}
• {"criterion_text":"- ●\tAny use of medication deemed by the trial medical professionals to pose a risk when combined with ketamine or likely to interfere with the study results, and that the participant is unwilling or unable to discontinue before enrolment"}
• {"criterion_text":"- ●\tElectroconvulsive therapy (ECT) and transcranial magnetic stimulation (TMS) are not permitted within four weeks prior to enrollment or during the trial."}
• {"criterion_text":"- ●\tKetamine treatment within 6 months preceding enrollment"}
• {"criterion_text":"- ●\tNot able to provide informed consent to participate in clinical research"}
• {"criterion_text":"- ●\tBMI under 16 or over 35 or body weight over 150 kg"}
• {"criterion_text":"- ●\tOutpatients with acute suicide risk as assessed by clinician’s examination"}
• {"criterion_text":"- ●\tHospitalized patients with acute suicide risk, unless enrollment doesn’t interfere with clinical security procedures per investigator’s judgement"}
• {"criterion_text":"- ●\tOngoing psychotic symptoms unless exclusively explained by the current depressive episode"}
• {"criterion_text":"- ●\tOngoing hypomanic episode"}

Primary endpoints

• {"endpoint_text":"- •\tTime-to-relapse after induction phase assessed by clinician rated MADRS between all 3 treatment arms","definition_or_measurement_approach":"Assessed by clinician-rated MADRS (Montgomery-Åsberg Depression Rating Scale); endpoint is time-to-relapse compared across the three treatment arms."}
• {"endpoint_text":"- •\tTime-to-relapse after the last ketamine infusion assessed by clinician rated MADRS between all three treatment arms","definition_or_measurement_approach":"Assessed by clinician-rated MADRS after last ketamine infusion; endpoint is time-to-relapse compared across the three treatment arms."}

Secondary endpoints

• {"endpoint_text":"- •\tAssess frequency, severity and duration of ARs/SARs through clinical interview, observation, SCI-2 SF, DLCQ and PreKET symptom checklist, patient chart review, spontaneously reported adverse events from signing the ICF to Final visit.","definition_or_measurement_approach":"Safety assessment via clinical interview, observation and specified instruments (SCI-2 SF, DLCQ, PreKET symptom checklist), patient chart review and spontaneously reported adverse events from informed consent signing to final visit."}

Norway

Earliest CTIS Part Ii Submission Date

03-10-2025

Latest Decision Or Authorization Date

26-03-2026

Processing Time Days

174

Number Of Sites

11

Number Of Participants

230

Primary sponsor

Full Name

Ostfold Hospital Trust

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway