Ketamine Clinical Trials
A pilot study on oral S-ketamine for depression and demoralisation in patients with advanced cancer receiving palliative care
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Organisation Name: Investigator-initiated
Overal Status: Planned
Start Date: 2019-06-10
Lead Sponsor: Investigator-initiated
Brief Summary: Rationale: patients with cancer for whom no curative treatment options remain often experience depression and/or demoralization. Currently available treatments are inadequately able to diminish these conditions within a timely matter. Ketamine, an N-methyl-D-aspartic acid (NMDA) glutamate receptor antagonist, has shown efficacy as a rapid acting antidepressant and is hypothesized to constitute an acceptable and effective treatment option for depression and demoralization in advanced cancer patients.
Objective: evaluating the feasibility of a future randomized controlled trial (RCT) for the efficacy of oral ketamine in the treatment of depression and/or demoralization in patients with advanced cancer for whom no curative anti-cancer treatments remain.
Study design: a single center, open-label, phase II, clinical pilot study aimed to assess the feasibility of a future randomized controlled trial, based on limited efficacy testing, safety, tolerability, acceptability, participation experience, and recruitment/retention rates of oral S-ketamine for the treatment of depression and demoralization in advanced cancer patients.
Study population: 10 advanced cancer patients for whom no curative treatment options remain, age 18 or older, recruited within a 12-month period from the department of medical oncology from the University Medical Center of Groningen (UMCG).
Intervention: patients will receive an oral dose of 0.5 mg (minimum) to 2.5 mg (maximum) S-ketamine twice per week for a five week period.
Main study parameters/endpoints: Hint of efficacy of the intervention defined as a clinically important reduction in depression and/or demoralization in at least 30% of participants who commenced treatment. Feasibility of the intervention will be judged based on safety, tolerability and acceptability as indicated by (1) greater than 80% of significant adverse effects resolving within 120 minutes of each administration, (2) less than 20% dropout rate secondary to adverse effects and (3) feedback from participants regarding treatment sessions and assessments.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: participation in this pilot study is expected to pose minimal burden to participants and may directly benefit participants. The treatment sessions will take place at the department of Oncology and will last for approximately 150 minutes. Study visits are kept to a minimum in both amount and duration, so as to minimize participant burden. Where possible, treatment and study visits are combined. Follow-up may be conducted by phone. At sub-anaesthetic dosages, acute side effects of ketamine treatment are common, but most of them resolve shortly after dose administration. Limited data from other populations are available regarding cumulative and long-term risks of ketamine use.
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