None listed
Conditions
Brief summary
Low dose ketamine has been shown to produce rapid (within hours) improvements in mood in patients with major depression. We plan to test ketamine in depressed patients with advanced cancer, for whom rapid improvement in mood may be particularly important in the context of limited life expectancy. The study has 3 stages: Stage 1: showing that ketamine improves mood; Stage 2: showing this effect can be maintained after repeated (weekly) dosing); and Stage 3: exploring the relationship between dose and improvement in mood.
Interventions
- 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 ran
- 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
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Male or female; any cancer type; receiving palliative care; life expectancy >3 months. Major depression with baseline Montgomery-Asberg Depression Rating Scale (MADRS) scores >20. Advanced (incurable cancer), adequate hepatic/renal function.
Exclusion criteria
Presence of cerebral metastases, ECOG performance status <4, not on other experimental medication. Current use of ketamine for analgesia.
Outcome results
None listed