Kiwis in drug trial against depression

Kiwi patients are taking part in the largest clinical trial yet to evaluate the effectiveness of ‘‘club drug’’ ketamine in the treatment of depression.

Ketamine is used illicitly as an hallucinogenic recreational drug and clinically as an anaesthetic.

It is not approved for clinical use in depression treatment in New Zealand, where it is a class C drug.

A growing body of evidence suggests the drug may be effective and fast-acting against major depression.

The University of New South Wales is running the study and will recruit 200 adult patients who have not responded to existing medicines.

Researchers will compare the effects of twice-weekly ketamine injections against placebos for four weeks in the largest randomised control trial of the drug’s anti-depressant characteristics.

Randomised controlled trials are considered the ‘‘gold standard’’ for gathering credible evidence of a drug’s effects.

Patients in New Zealand will be evaluated at the University of Otago.

The first patients have begun treatment in New South Wales. Victoria patients will be recruited in the next few months, followed by five study groups in Australia and New Zealand. University of New South Wales Professor Colleen Loo said the institute has spent five years investigating ketamine’s potential.

‘‘Ten separate randomised placebocontrolled trials involving about 250 participants worldwide have shown a single dose of ketamine produces rapid anti-depressant effects within hours, even in treatment-resistant patients.

‘‘However, attaining lasting remission remains a challenge. This trial will allow us to examine the effects of repeated dosing and whether the positive effects of ketamine on depression can be sustained.

Subjects will be randomised in a ‘‘double blind’’ trial, meaning neither patients nor researchers will know whether they receive ketamine or a placebo. After initial treatment, patients will be monitored over a four-week period to assess the impact of ketamine on mood and they can choose to continue to receive treatment after the first phase.

Loo said an evidence-based approach was crucial to assess the effectiveness and safety of ketamine as a depression treatment.

‘‘Some clinics in Australia and overseas continue to offer off-label ketamine treatments to patients with depression in an unsafe manner and with minimal care. This practice is premature and irresponsible, given that the effectiveness and safety of this treatment approach involving repeated dosing has yet to be tested in controlled trials.’’

In 2010 and 2011, patients diagnosed with treatment resistant depression at a mental health facility in Dunedin were given ketamine as part of an off-label treatment, a decision that was the subject of a complaint to the Health and Disability Commission.

The Southern District Health Board accepted changes were needed after an investigation into its use of ketamine.

The drug was first synthesised in 1962 and its potential as a fast-acting antidepressant has gathered pace, but it remains controversial due to its hallucinogenic properties and the risk of abuse.

A review in 2015 by the Cochrane Collaboration, a trusted global healthcare evidence-based organisation, said the potential for ketamine as an antidepressant needed more research and trials as the evidence was limited.

The University of New South Wales says the drug targets a signalling chemical in the brain called glutamate, in contrast to other anti-depressants that affect neurotransmitters such as serotonin.

But the hallucinogenic properties can be disorienting, including out-of-body and near-death experiences.