Effects of Intranasal Ketamine on Depression and Anxiety in Palliative Care Cancer Patients

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Zurich

About this trial

With progression of cancer, patients and their caregivers experience challenging emotional distress, which can make them feel depressed and very anxious.

Patients with advanced cancer often do not have long to live. However, most antidepressants take a long time to act and cause unwanted side effects. There is hence a need for a fast acting antidepressant with fewer unwanted side effects.

Ketamine is an effective and fast acting antidepressant originating from pain treatment, which has few unwanted side effects. It can be taken by a patient as a nasal spray when it is needed.

The idea of treating depression and anxiety in cancer patients in palliative care with ketamine nasal spray is new. How effective ketamine will be at reducing depression and anxiety in patients is unknown . It is also unknown whether this kind of treatment will be safe and practical for palliative care patients.

This study aims to answer these questions. Patients will be treated with a low dose (5 mg) of ketamine nasal spray and then measure its effectiveness, practicality and safety. Questionnaires will be used to measure these outcomes.

If treating depression and anxiety with ketamine nasal spray proves to be effective, practical and safe, then it could help to improve the quality of life for palliative care patients and reduce the burden of their caregivers.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Informed Consent as documented by signature;

HADS total score of 6 or greater;

Age 18 years or older;

Progressive cancer diagnosis (estimated life expectancy 24 months or more)

Disqualifiers

Clinician assessed cognitive impairment;

Clinician assessed alcohol or drug abuse;

Pregnancy or breast-feeding;

Severe hypertension (greater than 200/120 mmHg);

Trial design

Design model

Single group

Treatments tested in this trial

  • Intranasal ketamine hydrochloride

    Drug

    Flexible-dose intranasal ketamine hydrochloride (5 - 50 mg)

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: KetamineOther 1 intervention

Trial outcomes

Primary outcomes

1

Change in depressive symptoms assessed by the MADRS

Montgomery- Asberg Depression Scale (MADRS), 10 items, higher values indicate increasing symptom burden and total scores range from 0 to 60.

Time frame
From start of treatment at week 1 (baseline) to the end of treatment at 8 weeks

Secondary outcomes

1

Change in anxiety assessed by the HAM-A questionnaire

Hamilton Anxiety Rating Scale (HAM-A), 14 items, higher values indicate increasing symptom burden and total scores range from 0 to 56.

Time frame
From start of treatment at week 1 (baseline) to the end of treatment at 8 weeks
2

Change in quality of life assessed by the QLQ-C30 questionnaire

EORTC Quality of Life Questionnaire (QLQ-C30), 30 items, higher values of questions 1-28 indicate increasing symptom burden / decreasing quality of life and total scores range from 0 to 112. Higher values on the questionnaires final two questions (29, 30) indicate improved health and quality of life. Total scores on these final two questions range from 0 to 14.

Time frame
From start of treatment at week 1 (baseline) to the end of treatment at 8 weeks
3

Change in sleep quality assessed by the PSQI questionnaire

Pittsburgh Sleep Quality Index (PSQI), 10 items, higher values indicate decreasing sleep quality and total scores range from 0 to 21.

Time frame
From start of treatment at week 1 (baseline), at week 4 and at end of treatment at 8 weeks
4

Change in depressive symptoms assessed by the HADS questionnaire

Hospital Anxiety and Depression Scale (HADS), 14 items, higher values indicate increasing symptom burden and total scores range from 0 to 21.

Time frame
From start of treatment at week 1 (baseline) to the end of treatment at 8 weeks

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: