Evaluation of the feasibility of a trial on the efficacy of oral esketamine for the treatment of depression and/or demoralization in patients with advanced cancer who receive palliative care.
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of this pilot study is to decide whether it is feasible to
conduct a larger trial on the effectiveness of oral esketamine for the
treatment of depression and demoralization in patients with advanced cancer
receiving palliative care. This will be judged by preliminary effectiveness,
safety, tolerance and acceptability of the intervention, and acceptability of
the study procedures. These parameters will be assessed both quantitatively and
qualitatively.
Secondary outcome
• Decrease in self-reported depression severity, as expressed by a decrease in
total score on the Beck Depression Inventory (BDI);
• Changes in patients* quality of life, as expressed by a decrease in total
score on the McGill Quality of Life Questionnaire (MQOL);
• Decrease in anxiety, expressed as a decrease in total score on the Death and
Dying Distress Scale (DADDS);
• Experiences of participants during the trial, as assessed by in-depth,
semi-structured interviews.
Background summary
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.
Study objective
Evaluation of the feasibility of a trial on the efficacy of oral esketamine for
the treatment of depression and/or demoralization in patients with advanced
cancer who receive palliative care.
Study design
A single center, open-label, phase II, clinical pilot study aimed to assess the
feasibility of a future trial, based on limited efficacy testing, safety,
tolerability, acceptability, feedback of participants, and
recruitment/retention rates of oral esketamine for the treatment of depression
and demoralization in advanced cancer patients.
Intervention
Patients will receive an oral dose of 0.5 mg (minimum) to 3.0 mg (maximum)
S-ketamine twice per week for a five week period.
Study burden and risks
Participation in this pilot study is expected to pose some burden to
participants (given the frequency of the treatment sessions) 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.
Follow-up meetings 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.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
• Older than 18 years of age;
• Sufficient understanding of spoken and written Dutch;
• DSM-5 diagnosis of MDD, first or recurrent episode, ascertained by the Mini
International Neuropsychiatry Interview (MINI-plus) and/or demoralization as
indicated by a score of 30 on the Demoralization Scale;
• Advanced malignancy with no curative antitumor treatment possibilities as
determined by a physician at the oncology department.
Exclusion criteria
- Depression with psychotic features, according to the DSM-5;
- Previous or comorbid schizophrenia spectrum or other psychotic disorder
according to the DSM-5, not including previous MDD with psychotic features;
- Comorbid moderate or severe dependence of alcohol or drugs according to the
DSM-5, not including tobacco-related and caffeine-related disorders;
- Comorbid delirium, according to the DSM-5;
- Recent (within the last 4 weeks) or current use of non-prescribed
psychoactive compounds, including cannabis and Saint John*s wort;
- Electroconvulsive therapy (ECT) sessions or antidepressant treatment changes
planned for the period of the study;
- Current use of benzodiazepines and benzodiazepine-like agents (zolpidem,
zopiclone) in excess of 2 mg lorazepam or an equivalent per day;
- Current use of ketamine;
- Mental incompetence to provide informed consent;
- Presence of any contra-indication for ketamine use. Ketamine is
contra-indicated in persons with uncontrolled blood pressure, persons whom have
shown hypersensitivity to the drug or its components, in persons with eclampsia
or pre-eclampsia, severe coronary or myocardial disease, or a cerebrovasculair
accident or cerebral trauma, and in patients who use medication that ketamine
interacts with on a major level, such as monoamine oxidase inhibitors (MAOi).
- Inability to comply with treatments and/or assessments.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-001621-27-NL |
| CCMO | NL69770.042.19 |