A study on ketamine as a treatment for depression and demoralization in patients with advanced cancer

Phase 1

• Conditions: Major depressive disorder; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2019-001621-27-NL
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-22
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Male or female;
• Older than 18 years of age;
• Good 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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;
- In patients with seizures;
- 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 clinical trial of medicinal product
• Study Design: Not specified