Ketamine maintenance treatment for depression: A multicenter open-label randomized controlled trial (PreKET)

Trial details

Who runs it

Ostfold Hospital Trust

Trial code

EU 2025-521330-29-00

Record updated

2026. szeptember 18.

Original description

To examine the long-term efficacy of maintenance therapy with IV ketamine following induction treatment of treatment-resistant depression (TRD).Read full original descriptionShow less

Ketamine maintenance treatment for depression: A multicenter open-label randomized controlled trial

To examine the long-term efficacy of maintenance therapy with IV ketamine following induction treatment of treatment-resistant depression (TRD).

Inclusion: ● Are fluent in spoken and written Norwegian; ● Able to provide informed consent to participate in the current study. This may include involuntarily hospitalized patients; ● Male or female adults aged 18 years or older; ● Meet DSM-5 criteria for MDD or bipolar-2 disorder as assessed by the MINI version 7.0.2; ● Have a current MDE of at least moderate severity defined by a Montgomery-Åsberg Depression Rating Scale (MADRS) score of ≥ 20; ● Meet 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; ● Women of childbearing potential (WOCBP) as defined in Section 10.4.1 must have a negative urine and/or blood hCG pregnancy test at study entry and prior to maintenance ketamine infusion and must agree to use adequate birth control through the last ketamine infusion; Only highly effective contraception methods are permitted in this trial. See Section 10.6.2 Contraception guidelines for a list of these methods.

Exclusion: ● Obstructive or central sleep apnoea requiring treatment with oxygen, CPAP/BiPAP; ● Previous anaphylactic reaction to ketamine; ● Any 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; ● Ongoing or previous manic episodes; ● Electroconvulsive therapy (ECT) and transcranial magnetic stimulation (TMS) are not permitted within four weeks prior to enrollment or during the trial; ● Chronic respiratory failure (requiring LTOT and/or GOLD 3 (severe) or higher); ● Any 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; Known hypersensitivity to any ingredients of ketamine; ● History of any psychotic or bipolar type 1 disorder as assessed by the Mini International Neuropsychiatric Interview (MINI v. 7.0.2); ● History of severe personality disorder, severe dissociative disorder, severe obsessive-compulsive disorder, autism-spectrum disorder, or other psyciatric comorbidities, assessed through MINI and/or medical history, that may interfere with the interpretation of the study results or pose a health risk to the participant per investigator’s judgement; ● Current eating disorder with active purging as assessed by MINI; ● Current or past severe substance/alcohol use disorder (according to DSM-5 criteria) or substance/alcohol use that, in the investigator’s judgment, may compromise participant safety, study integrity, or compliance with study procedures; ● Cardiovascular 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); ● Liver 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); ● Kidney failure (creatinine clearance < 30 mL/min by Cockcroft-Gault); ● Women who intend to become pregnant or are breast-feeding; ● Pregnant women as assessed by urine and/or blood hCG pregnancy tests; ● Glaucoma or globe injury; ● Uncontrolled hypo- or hyperthyroidism; ● Current or suspected increased intracranial pressure; ● Acute intermittent porphyria; ● Ketamine treatment within 6 months preceding enrollment; ● Not able to provide informed consent to participate in clinical research; ● BMI under 16 or over 35 or body weight over 150 kg; ● Outpatients with acute suicide risk as assessed by clinician’s examination; ● Hospitalized patients with acute suicide risk, unless enrollment doesn’t interfere with clinical security procedures per investigator’s judgement; ● Ongoing psychotic symptoms unless exclusively explained by the current depressive episode; ● Ongoing hypomanic episode.

EU CTIS 2025-521330-29-00