Clinical TrialPalliative & End-of-Life DistressKetamineActive not yet recruiting

A pilot study on oral s-ketamine for depression and demoralization in patients with advanced cancer receiving palliative care

Open-label Phase II pilot (n=10) assessing feasibility of oral S-ketamine (Ketanest-S) to treat depression and demoralization in patients with advanced cancer receiving palliative care.

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Target Enrollment
10 participants
Study Type
Phase II interventional
Design
Non-randomized

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Compound research: KetamineTopic research: Palliative & End-of-Life DistressResearch in Netherlands

Detailed Description

This single-site, open-label pilot evaluates feasibility and preliminary efficacy of oral S‑ketamine (Ketanest‑S) in adults with advanced, non-curable cancer and major depressive disorder and/or demoralization.

Primary outcome is feasibility judged by safety, tolerability and acceptability (eg >80% of significant adverse effects resolve within 120 minutes, <20% dropout due to adverse effects, and participant feedback). Secondary outcomes include changes in depression (BDI/HDRS), anxiety (HADS, DADDS), quality of life (MQOL) and qualitative interviews of patient experience.

Study Protocol

Preparation

sessions

Dosing

sessions

Integration

sessions

Therapeutic Protocol

other

Study Arms & Interventions

Oral S-ketamine

experimental

Open-label, single-arm administration of oral S-ketamine (Ketanest-S solution for oral use) in patients with advanced cancer and depression or demoralization.

Interventions

  • Ketamine
    via Oral

    Ketanest-S formulation (concentration 0.33 mg/ml); dosing per protocol.

Participants

Ages
18 – 64
Sexes
Male & Female

Inclusion Criteria

  • Male or female; older than 18 years of age; good understanding of spoken and written Dutch; DSM-5 diagnosis of major depressive disorder (first or recurrent episode) ascertained by the MINI-plus and/or demoralization indicated by a score ≥30 on the Demoralization Scale; advanced malignancy with no curative antitumour treatment options as determined by an oncology physician.

Exclusion Criteria

  • Depression with psychotic features; previous or comorbid schizophrenia-spectrum or other psychotic disorder (excluding previous MDD with psychotic features); comorbid moderate or severe alcohol or drug dependence (excluding tobacco and caffeine); comorbid delirium; recent (within 4 weeks) or current use of non-prescribed psychoactive compounds including cannabis and St John’s wort; scheduled ECT sessions or planned changes to antidepressant treatment during the study; current use of benzodiazepines or benzodiazepine-like agents in excess of 2 mg lorazepam (or equivalent) per day; current use of ketamine; mental incompetence to provide informed consent; patients with seizures; any contraindication for ketamine use (eg uncontrolled blood pressure, hypersensitivity to ketamine or components, eclampsia/pre-eclampsia, severe coronary or myocardial disease, cerebrovascular accident or cerebral trauma, or interacting medications such as MAO inhibitors); inability to comply with treatments and/or assessments.

Study Protocol, Arms & Participants

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Study Details

  • Status
    Active not yet recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment10 participants
  • Timeline
    Start: 2020-09-17
    End: 2024-12-31
  • Compound
    Ketamine
  • Topic
    Palliative & End-of-Life Distress

Locations

Netherlands

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