Effects of low dose intramuscular ketamine on depression ratings in depressed patients with cancer in palliative care

This randomised controlled trial (n=50) investigates the effects of low-dose intramuscular ketamine on depression ratings in individuals with major depressive disorder (MDD) and cancer in palliative care.

The trial, registered on ANZCTR with the identifier ACTRN12610001011077, consists of three stages. In Stage 1, participants receive a single open-label dose of ketamine (1mg/kg). Stage 2 involves multiple open-label doses of ketamine (1mg/kg) repeated at weekly intervals for responders from Stage 1. In Stage 3, patients are randomised to one of three double-blind ketamine dose arms (0.1mg/kg, 0.5mg/kg, 1.0mg/kg IM).

Primary outcomes include the Montgomery-Asberg Depression Rating Scale (MADRS) scores, assessing mean scores, change from baseline, and proportion of subjects showing response and remission at various time points. Secondary outcomes involve the Hospital Anxiety and Depression Scale (HADS), demoralization scales, and safety/tolerability assessments.

Eligible participants are males or females with any cancer type, receiving palliative care, and having a life expectancy greater than three months. The study is conducted at the University of Otago, New Zealand, funded by the University of Otago, and approved by the Lower South Regional Ethics Committee. Recruitment is ongoing since March 23, 2011, and the last available update was on March 23, 2011.

Trial Details

- Stage 1: ketamine 1mg/kg single dose, open label. Patients who show a response to ketamine in Stage 1 are eligible to enter Stage 2. - Stage 2: ketamine 1mg/kg multiple doses repeated at approximately weekly intervals, open label. Patients may continue to receive ketamine as long as beneficial effects on mood persist - After completion of Stage 1, enrollment in Stage 3 will commence. Patients who have participated in Stages 1/2 are not eligible to enter Stage 3. - Stage 3: patients will be randomized to one of 3 ketamine dose arms (0.1mg/kg, 0.5mg/kg, 1.0mg/kg IM), single dose, double blind

Trial Number ACTRN12610001011077

Data attribution

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