Professor Ilina Singh, our theme leader for patient and public involvement, is the first author on a new paper which sets out principles for responsibly testing innovative treatments for severe depression.
The paper, published in the Lancet Psychiatry, highlights the need for ethical and innovative professional action, by setting out key qualities of the responsible clinician in providing ketamine treatment. Ketamine is known to be an effective antidepressant for people whose depression has not responded to other treatment.
Professor Singh 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.
The paper agrees 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.
It 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
‘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.”