BridgeMD
Ketamine maintenance treatment for depression: A multicenter open-label randomized controlled trial (PreKET)
EU CTIS ID: 2025-521330-29-00
What this study is testing
To examine the long-term efficacy of maintenance therapy with IV ketamine following induction treatment of treatment-resistant depression (TRD).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- ● 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
You likely can't join if
- ● Women who intend to become pregnant or are breast-feeding
- ● Chronic respiratory failure (requiring LTOT and/or GOLD 3 (severe) or higher)
- ● Obstructive or central sleep apnoea requiring treatment with oxygen, CPAP/BiPAP
- ● Pregnant women as assessed by blood HCG tests
- ● Glaucoma or globe injury
- ● Previous anaphylactic reaction to ketamine
See the full eligibility criteria
Who can join
- ● 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 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.
What rules you out
- ● Women who intend to become pregnant or are breast-feeding
- ● Chronic respiratory failure (requiring LTOT and/or GOLD 3 (severe) or higher)
- ● Obstructive or central sleep apnoea requiring treatment with oxygen, CPAP/BiPAP
- ● Pregnant women as assessed by blood HCG tests
- ● Glaucoma or globe injury
- ● Previous anaphylactic reaction to ketamine
- ● Uncontrolled hypo- or hyperthyroidism
- ● Current or suspected increased intracranial pressure
- ● Acute intermittent porphyria
- ● 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.
- ● 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.
- ● 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
- • 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.