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

Phase 2

Recruiting

• Conditions: hopelessness; Sadness; 10027946

• Registration Number: NL-OMON49647
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 10

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified