Principles for responsibly testing innovative treatments for severe depression are set out in a new article in The Lancet Psychiatry, 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.
“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,"
said lead author Professor Ilina Singh from the Oxford University Department of Psychiatry.
Not A Miracle
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.
“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,"
said Dr Rupert McShane, a consultant psychiatrist at Oxford Health NHS Foundation Trust, and lead on the Oxford ketamine treatment programme for depression.
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:
Clearly identified need
Balancing safety and efficacy
Generating robust evidence
Continuous reflexive evaluation
Coordinated interdisciplinary action
Effective and proportionate oversight
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.
 Prof Ilina Singh, EdD, et al. Ketamine treatment for depression: opportunities for clinical innovation and ethical foresight. The Lancet Psychiatry: Volume 4, Issue 5, p419-426, May 01, 2017