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‘Getting the right level of oversight’

A new study sets out principles for responsibly testing innovative treatments for severe depression.

6 April 2017 | News Research

A new paper published in the Lancet Psychiatry sets out principles for responsibly testing innovative treatments for severe depression, based on treating over 100 patients with approximately 1,000 infusions of ketamine, over six years in Oxford. Ketamine is known to be an effective antidepressant for people whose depression has not responded to other treatment.

The paper highlights the need for ethical and innovative professional action by setting out key qualities of the responsible clinician in providing ketamine treatment.

Professor Ilina Singh from the Oxford University Department of Psychiatry and lead author on the paper, said: “Our approach balances the potential harms of ketamine use for treatment-resistant depression, such as its misuse potential, with a focus on reporting structures that promote the broad benefits of clinical innovation and the ethical judgment of the clinician. We argue that the clinician who exemplifies inventiveness, humility and responsibility can contribute to innovation and promote justice for patients who seek ketamine treatment.”

The paper also recommends that:
• Clinics should routinely submit data to a national registry about each patient treated with ketamine.
• Professional bodies should provide regularly updated guidance on the details of clinical protocols in the light of emerging evidence.

‘Not a miracle’

Dr Rupert McShane, a consultant psychiatrist at Oxford Health NHS Foundation Trust, and lead on the Oxford ketamine treatment programme for depression, said: “I have seen ketamine work where nothing has helped before. But ketamine is a drug not a miracle, and maintaining the benefit is a challenge. So far, the only way we have found to maintain the benefit is repeated dosing.

“We think that patients’ treatment should be in specialist centres and formally tracked in national or international registries. This will help us to pick up any safety or abuse problems with longer term use, and narrow down what dose, frequency, route and duration of treatment works best.

“Getting the right level of oversight is important: not enough, and we risk overuse and an inevitable backlash; too much, and we leave patients in misery unnecessarily. It is helpful that the American Psychiatric Association independently came to the same conclusion.”

Ketamine is a licensed drug in the UK, and so it can be prescribed by any doctor. In the last year, private ketamine clinics have burgeoned in the US. There are wide variations in the clinical checks before a patient receives treatment, and the paper’s authors say that there is a need for clear guidelines and registries to track results about how patients with depression respond to ketamine.

Key areas requiring further investigation include working out the safety of repeated ketamine treatment, and the potential for misuse.

Patient stories

64 year old David has bipolar disorder. He said: “Ketamine means that I can live for a few days a week rather than just exist, but most importantly, (it) gives my wife back the man she married 40 years ago for those days. The ketamine doesn’t have the unpleasant effects of other antidepressants, such as lithium tremor, or tiredness or nausea and I am fine to go home by train after 2 hours.”

Louise, a 36 year old former nurse, said: “In depression and anorexia you get a constant, overwhelming bombardment of negative intrusive thoughts surging through your brain. You are just instantly paralysed and snowed under: you don’t stand a chance.

“Ketamine slows this down so you can fight back. I’m the most stable I’ve been in years and have hardly spent any time in hospital compared to before ketamine.

“I definitely do not feel at all, in any way “hooked on” or addicted to the ketamine. I have more trouble with withdrawal and side-effects if I miss a couple of doses of my (standard) antidepressant than I do with the ketamine.”

Broad agreement
The authors of The Lancet Psychiatry paper agree with recently published consensus views from the Royal College of Psychiatry and the American Psychiatric Association on how to treat patients with ketamine for mood disorders, outside of research.

The paper also sets out six principles of responsible innovation:
1. Clearly identified need
2. Balancing safety and efficacy
3. Generating robust evidence
4. Continuous reflexive evaluation
5. Coordinated interdisciplinary action
6. Effective and proportionate oversight

Find out more about participating in a research study testing a treatment for depression.

Last updated: 14 August, 2017

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