ow dose individually-tailored subcutaneous ketamine infusion for the treatment of depression in palliative care patients

Phase 2

• Conditions: Advanced life limiting illnesses; Mental Health - Depression; Major Depressive Disorder

• Registration Number: ACTRN12618001586202
• Lead Sponsor: niversity of Technology Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-25
• Study Completion: 2021-05-25
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Patients known to the palliative care services in the acute hospital, palliative care units or in the community with advanced life limiting illness and major depressive disorder in Australia (inclusive of those with very limited prognosis with Australia-modified Karnofsy Performance Scale [AKPS] 30 or less, and those with severe depression with MADRS 35 or more)

Inclusion criteria
•Adult males or females known to palliative care service with age greater than or equal to 18 yrs
•Palliative intent of treatment due to irreversible medical illnesses
•Patient Health Questionnaire-2 (PHQ-2) score greater than or equal to 3, and
•Major Depressive Disorder defined by Endicott Criteria diagnosed by trained personnel (e.g. psychiatry team, psychologist or trained research team member) with:
•MADRS Score greater than or equal to 16
•Willing and able to comply with all study requirements,
•Signed, written informed consent for the study

Exclusion Criteria

Exclusion criteria
•Australian-modified Karnofsky Performance scale (AKPS) score less than or equal to 10
•Having curative intent to treatment
•Palliative intent life prolonging measures such as target therapies, radiotherapy or intravenous antibiotics is acceptable
•Methylphenidate use in the last 4 weeks
•Changes to antidepressant doses in the last 2 weeks prior to the commencement of ketamine
•Ketamine use in the last 4 weeks
•Previous significant adverse effect or hypersensitivity to ketamine
•Concurrent phenobarbitone use
•Factors of increased risk of intracranial pressure:
i.Recent ischaemic or haemorrhagic cerebral vascular accident in the last 1 month
ii.Brain tumours with symptoms and signs of increased intracranial pressure
iii.Seizure in the last 6 months
iv.Head trauma with symptoms of increased intracranial pressure
v.Hydrocephalus
vi.Uncontrolled nausea (Greater than or equal to grade 3 despite 1 line of antiemetic), vomiting and headache (e.g. from cerebral metastases, trauma)
vii.Greater than or equal to grade 3 despite one line of antiemetics
•Factors of increased risk of sympathomimetic response (hypertension and tachycardia) with associated complications
i.Uncontrolled hypertension with systolic blood pressure greater than or equal to 160
ii.Tachycardia with heart rate greater than or equal to 120 per minute.
iii.Symptomatic ischaemic heart disease (e.g. exertional angina) and decompensated heart failure with NYHA class III and IV symptoms
iv.Uncontrolled Hyperthyroidism (Low TSH with high T3 and/or T4)
v.Diagnosis and history of Prophyria
•Factors of increased risk of intraocular pressure with its complications
i.Glaucoma
ii.Open eye injury / Acute globe injury
•Severe hepatic impairment: Bilirubin greater than or equal to 3 times upper limit of normal; AST and/or ALT > 5 times upper limit of normal - clinically determined to be due to hepatic impairment
•Severe renal impairment (Creatinine clearance <15ml/min by Cockroft Gault Equation)
•Other mental disorders apart from major depression (lifetime history schizophrenia/bipolar/mania)
•Recent substance misuse as determined by the treating and research clinicians

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Study feasibility measures of absolute numbers (including accrual rate per month throughout multiple centres) and proportions of palliative care patients, who are screened for depression, meet the study eligibility criteria, give consent, are treated with subcutaneous ketamine, and complete the study with repeated weekly dosing (according to response) for 4 weeks with a further 4 weeks of follow up (A total of 8 weeks)[End of study]