A new paper published in The Lancet Psychiatry sets out principles for responsibly testing innovative treatments for severe depression, based on treating more than 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, and that professional bodies should provide regularly updated guidance on the details of clinical protocols in the light of emerging evidence.
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.
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
The full paper, 'Ketamine treatment for depression: opportunities for clinical innovation and ethical foresight,' can be read in The Lancet Psychiatry.