Ketamine effective for treatment-resistant depression, study suggests


Date:
July 14, 2023
Source:
University of New South Wales
Summary:
Promising results in a trial of ketamine for severe depression
could lead to treatment becoming more affordable.


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A low-cost version of ketamine to treat severe depression has performed strongly in a double-blind trial that compared it with placebo.

In research published today in the British Journal of Psychiatry,
researchers led by UNSW Sydney and the affiliated Black Dog Institute
found that more than one in five participants achieved total remission
from their symptoms after a month of bi-weekly injections, while a
third had their symptoms improve by at least 50 per cent. The study
was a collaboration between six academic clinical mood disorder units
in Australia and one in New Zealand and was funded by the Australian
National Health and Medical Research Council (NHMRC).

"For people with treatment-resistant depression -- so those who have
not benefitted from different modes of talk-therapy, commonly prescribed antidepressants, or electroconvulsive therapy -- 20 per cent remission
is actually quite good," lead researcher Professor Colleen Loo says.

"We found that in this trial, ketamine was clearly better than the
placebo - - with 20 per cent reporting they no longer had clinical
depression compared with only 2 per cent in the placebo group. This is
a huge and very obvious difference and brings definitive evidence to
the field which only had past smaller trials that compared ketamine with placebo." How the trial worked The researchers recruited 179 people with treatment-resistant depression. All were given an injection of either a
generic form of ketamine that is already widely available in Australia as
a drug for anaesthesia and sedation -- or placebo. Participants received
two injections a week in a clinic where they were monitored for around two hours while acute dissociative and sedative effects wore off -- usually
within the first hour. The treatment ran for a month and participants were asked to assess their mood at the end of the trial and one month later.

As a double-blind trial, neither participants nor researchers
administering the drug were aware which patients received generic ketamine
or placebo, to ensure psychological biases were minimised. Importantly,
a placebo was chosen that also causes sedation, to improve treatment
masking. Midazolam is a sedative normally administered before a general anaesthetic, while in many previous studies the placebo was saline.

"Because there are no subjective effects from the saline, in previous
studies it became obvious which people were receiving the ketamine and
which people received placebo," Prof. Loo says.

"In using midazolam -- which is not a treatment for depression, but does
make you feel a bit woozy and out of it -- you have much less chance
of knowing whether you have received ketamine, which has similar acute effects." Other features of the recent trial that set it apart from
past studies included accepting people into the trial who had previously received electroconvulsive therapy (ECT).

"People are recommended ECT treatment for their depression when all
other treatments have been ineffective," Prof. Loo says.

"Most studies exclude people who have had ECT because it is very hard
for a new treatment to work where ECT has not." Another difference about
this trial was that the drug was delivered subcutaneously (injected into
the skin) rather than by drip, thus greatly reducing time and medical complexity. The study is also the largest in the world to date that
compares generic ketamine with placebo in treating severe depression.

Much more affordable Apart from the positive results, one of the standout benefits of using generic ketamine for treatment-resistant depression
is that it is much cheaper than the patented S-ketamine nasal spray
currently in use in Australia. Where S-ketamine costs about $800 per dose,
the generic ketamine is a mere fraction of that, costing as little as $5, depending on the supplier and whether the hospital buys it wholesale. On
top of the cost for the drug, patients need to pay for the medical care
they receive to ensure their experience is safe -- which at Black Dog
Institute clinics, comes to $350 per session.

"With the S-ketamine nasal spray, you are out of pocket by about $1200
for every treatment by the time you pay for the drug and the procedure,
whereas for generic ketamine, you're paying around $300-350 for the
treatment including the drug cost," Prof. Loo says.

She adds that for both S-ketamine and generic ketamine treatments, the
positive effects often wear off after a few days to weeks, so ongoing
treatment may be required, depending on someone's clinical situation. But
the prohibitive costs of the drug and procedure make this an unsustainable proposition for most Australians.

"This is why we're applying for a Medicare item number to fund this
treatment now, because it's such a powerful treatment.

"And if you consider that many of these people might spend many months
in hospital, or be unable to work and are often quite suicidal, it's
quite cost effective when you see how incredibly quickly and powerfully
it works. We've seen people go back to work, or study, or leave hospital because of this treatment in a matter of weeks." The researchers will
next be looking at larger trials of generic ketamine over longer periods,
and refining the safety monitoring of treatment.

Participating trial sites
* UNSW / Black Dog Institute * Royal Prince Alfred Hospital /
University of Sydney * NeuroCentrix Research Institute * Royal
Adelaide Hospital / University of Adelaide * Monash Alfred Psychiatry
Research Centre / Monash University * University of Otago * Gold
Coast University Hospital
Institutions of non-site collaborators
* Deakin University * University of Newcastle * The George Institute
for Global Health * University of Western Australia * RELATED_TOPICS
o Health_&_Medicine
# Pharmacology # Mental_Health_Research #
Today's_Healthcare # Personalized_Medicine
o Mind_&_Brain
# Depression # Mental_Health # Illegal_Drugs # Psychiatry
* RELATED_TERMS
o Postpartum_depression o Deep_brain_stimulation o Constipation
o Multiple_sclerosis o Clinical_depression o Antidepressant
o Lead o Electroconvulsive_therapy

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Materials provided by University_of_New_South_Wales. Original written
by Lachlan Gilbert. Note: Content may be edited for style and length.


========================================================================== Journal Reference:
1. Colleen Loo, Nick Glozier, David Barton, Bernhard T. Baune,
Natalie T.

Mills, Paul Fitzgerald, Paul Glue, Shanthi Sarma, Veronica
Galvez-Ortiz, Dusan Hadzi-Pavlovic, Angelo Alonzo, Vanessa Dong,
Donel Martin, Stevan Nikolin, Philip B. Mitchell, Michael Berk,
Gregory Carter, Maree Hackett, John Leyden, Sean Hood, Andrew
A. Somogyi, Kyle Lapidus, Elizabeth Stratton, Kirsten Gainsford,
Deepak Garg, Nicollette L. R. Thornton, Ce'lia Fourrier, Karyn
Richardson, Demi Rozakis, Anish Scaria, Cathrine Mihalopoulos,
Mary Lou Chatterton, William M. McDonald, Philip Boyce, Paul
E. Holtzheimer, F. Andrew Kozel, Patricio Riva-Posse, Anthony
Rodgers. Efficacy and safety of a 4-week course of repeated
subcutaneous ketamine injections for treatment-resistant depression
(KADS study): randomised double-blind active-controlled trial. The
British Journal of Psychiatry, 2023; 1 DOI: 10.1192/bjp.2023.79 ==========================================================================

Link to news story: https://www.sciencedaily.com/releases/2023/07/230714114752.htm

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