Ketamine Clinical Trials
Low dose individually-tailored subcutaneous ketamine infusion for the treatment of depression in palliative care patients
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Organisation Name: University of Technology Sydney
Overal Status: Suspended
Start Date: 29/07/2019
Brief Summary: Depression is common in patients who have advanced life-limiting illness. There are significant time pressures for antidepressants to have rapid-onset effect in some palliative care patients. Most antidepressants, due to their slow onset of action, have limited therapeutic benefits in patients with extremely short prognoses or those with severe depression that require rapid effect while waiting for the typical antidepressants to take effect. In the psychiatry literature, subanaesthetic doses of ketamine are emerging as a novel rapid-onset antidepressant for treatment resistant major depression with high response rates, though having short-lived effect. Countries
There has been no similar trial done using ketamine to treat even de novo depression in the population with advanced life-limiting illness. There is a need to explore the activity of ketamine in palliative care patients, particularly those with very limited prognosis and/or severe depression that require immediate intervention where typical antidepressants are of limited utility for depression.
Further evidence may potentially allow ketamine to be used to treat severe depression in patients with very limited but uncertain prognosis (e.g. in the range of weeks) and be considered as a bridging therapy for those who have a longer prognosis for the typical antidepressants to have effects.
Prior to researchers committing to a larger phase 2/3 double blinded, cross over, randomised controlled trial, testing the activity of ketamine as antidepressant in the palliative care population, a feasibility study will be conducted with the aim to investigate: the number of patients who participate in, and subsequently complete, the ketamine intervention; the potential effects of ketamine; and the safety and tolerability of ketamine in this population.
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 will be included in this study.
The intervention is an individually tailored subcutaneous infusion of ketamine, given at weekly intervals by response, commencing with 0.1-0.4mg/kg over 2 hours, up to 4 doses (4 weeks) with the maximal dose of 0.4mg/kg. This is followed by 4 weeks of follow up.
Commencement and titration of a typical antidepressant for depression by the treating clinical team’s choice if clinically appropriate (given 48 hours apart from ketamine administration) is allowed for ethical reasons.
Primary Outcome is the number of palliative care patients completing through each stage of the study. Main secondary outcomes include serious side effects (CTCAE), psychotomimetic and dissociative symptoms (BPRS/CADSS), depression score (MADRS), quality of life score (Q-LES-Q-SF) and Numeric Pain Rating Scale.
- Major Depressive Disorder
- Advanced life limiting illnesses
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