The largest study on the long-term effectiveness of ketamine on major depression has begun in NSW
The largest independent study on the long-term effectiveness of ketamine on major depression has begun in NSW, one of seven trial sites in Australia and New Zealand
The randomised trial comes after criticism of off-label use of ketamine for depression, which has not been tested in controlled trials. The trial is not associated with pharmaceutical interests.
Earlier trials around the world have shown a single dose of ketamine produced rapid antidepressant effects, even in treatment-resistant patients. But lasting remission had remained a challenge, University of NSW Professor of Psychiatry Colleen Loo said.
“This trial will allow us to examine the effects of repeated dosing and whether the positive effects of ketamine on an individual’s depression can be sustained over a long period,” Professor Loo said.
The three-year trial will invite 200 adults who have been unresponsive to existing medications for major depression, defined as low mood enduring for two weeks or more with a significant impact on daily functioning.
Ketamine will be administered by twice-weekly subcutaneous injections over four weeks, and the effects compared with a group receiving a placebo. Patients will be monitored for another four weeks to assess their mood, and may be able to continue ketamine treatment beyond the trial’s initial phase.
Professor Loo said an evidence-based approach to assess the effectiveness and safety of the medication was essential.
“Some clinics in Australia and overseas offer off-label ketamine treatments to patients with depression in an unsafe manner and with minimal care,” she said.
She called the practice “premature and irresponsible” while repeated dosing had yet to be tested in controlled trials.
The double-blind trial will be held at two sites in Sydney, two in Melbourne, one each in Adelaide and Perth, and one in Dunedin, New Zealand.