Australia’s largest ketamine trial for depression underway


Evaluation of the drug is much needed as some clinics offer repeated dosage without evidence of safety, says professor

The largest randomised double-blind trial to evaluate the effectiveness of ketamine as a new treatment for depression has begun in Australia and New Zealand.

Over the course of three years, researchers from the Black Dog Institute will analyse 200 adults who have not responded to existing medications for major depression, comparing the effects of twice-weekly ketamine treatment against a placebo over a four-week period.

The drug will be administered to patients via a needle into subcutaneous tissue.

Lead researcher, UNSW Professor Colleen Loo who is based at the Black Dog Institute, says previous studies have found a single dose of ketamine produces rapid antidepressant effects within hours, but achieving lasting effectiveness remains a challenge.

“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 longer period,” says Professor Loo.

Ketamine is already being used in Australian clinics to treat depression but without clinical evidence of its safety, so understanding the effects of repeated dosing is vital, she says.

“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,” says Professor Loo.

“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.

“We will be working very closely with clinical pharmacologists during this trial to understand the specific dosage required for each individual and the likely effects it will have,” she says.

Ketamine is known to target glutamate in the brain, as opposed to serotonin or noradrenaline with other antidepressants.

Studies have shown that the drug can have disorienting or dissociative side effects, which accounts for its use as a recreational drug, says the Black Dog Institute.

These are effects are short-lived, however, lasting about half an hour after each treatment while beneficial mood effects are known to persist for days.

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2 Comments

  1. steve
    18/08/2016

    “Sublingual ketamine for treatment-resistant
    depression.”

    Since September 2014 I have been prescribing low-dose
    sublingual ketamine to help my patients suffering from treatment-resistant
    depression. To date 21 have started this therapy with an initial monitored dose
    being given in my rooms and subsequent doses being taken at home with dosage
    and dose intervals being varied according to progress. [1]

    My peer review group, having been given regular
    updates on progress, initially referred patients for treatment and currently
    two of the members are now prescribing ketamine for their own patients. In
    addition our local private hospital’s Medical Advisory Committee has approved
    the use of ketamine for treatment-resistant psychiatric disorders after being
    supplied relevant information.

    Results to April 2016:

    3 have not responded.

    9 have showed partial improvement.

    9 have improved strongly either attaining remission [“best
    I’ve been for 15 years”] or near-remission.

    During the initial test dose some have recorded small,
    temporary increases in blood pressure and pulse rate. The most common
    subjective experience has been that of feeling light-headed and dissociative
    symptoms e.g. ‘time slowing” and “wave-like sensations” have been described at
    higher doses. There have been neither reports of bladder symptoms nor evidence
    of diversion or addiction.

    Although treatment resistant depression has been the
    primary target almost all patients have co-morbidities and there have been
    significant improvements described in GAD, PTSD, SAD, neuropathic pain and
    acute suicidality. The age range has been 30-70 and both unipolar and bipolar
    depressive episodes have responded. In all cases ketamine has been added to
    current therapy and, for many, the original treatments have been reduced or
    stopped over time.

    Ketamine for my group of patients living with severe chronic
    illness has not been a “cure” in that the majority have required further doses
    at intervals varying between every few days to 3 months to maintain benefit and
    some, particularly bipolar patients, have needed further courses for new
    episodes.

    Using low-dose sublingual ketamine, which can be
    safely taken at home, has meant that treatment has been affordable even for
    those receiving income support although one patient has given up their daily
    newspaper and another nicotine, in order to mitigate the cost.

    For my patients ketamine has not been a ‘magic bullet,’
    nor is it suitable for everyone, but it has proved to be an extremely useful
    addition to the range of treatments available for severe depression. Based on
    my experience and that of many other psychiatrists around the world, [I am a
    member of an online group which has collectively treated more than 2,000
    patients with ketamine over the past 3 years], I think we should all heed our
    College’s position that ketamine is an innovative therapy suitable, with
    appropriate safeguards, for patients with treatment-resistant depression. [2]

    Dr. Stephen J Hyde

    FRANZCP

    References:

    [1] Hyde SJ (2015) ”Ketamine for Depression.” Xlibris.

    [2] RANZCP (Nov 2015 online) Clinical Memorandum CLM
    PPP “Use of ketamine for treating depression.”

  2. I’d literally do ANYTHING to be free from my treatment-resistant major depression & anxiety. I only WISH I could try ketamine infusions.

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