Psilocybin shows great promise for those with treatment resistant depression

The World Health Organization describes depression as "the leading cause of disability worldwide" afflicting over 350 million people globally and costing the U.S. more than $200 billion annually which makes the promising research published 17 May 2016 in Lancet Psychiatry extremely timely and relevant. The news media has taken notice as well.

The Lancet Psychiatry article titled 'Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study'  (PDF) by researchers at the Imperial College London, ranked as a top 10 Univesity globally, was a pilot study which involved 12 patients, all whom had a failed response to standard medications and had suffered with major depression for an average of an astounding 17.8 years.

Patients received two doses of psilocybin (10 mg and 25 mg, orally, 7 days apart) in a supportive setting with psychological support provided before, during, and after each session if needed.  The psilocybin utilized in the study was synthetic, no actual mushrooms were consumed in order to provide a known amount of psilocybin for each patient. fMRI data was collected but will be detailed at a later date.

Since this was a feasibility trial, there was no control group.  However, since these patients had tried various other medications over time, this may be considered an 'N of 1' study with the patients serving as their own controls.

No serious or unexpected adverse events occurred during the course of the study and all patients showed some reduction in depression severity at 1 week that was sustained in the majority for 3 months. Eight (67%) of the 12 patients achieved complete remission at 1 week and seven patients (58%) continued to meet criteria for response at 3 months, with five of these (42%) still in complete remission. This is quite remarkable since the equivalent remission rate for SSRIs is around 20%. Unlike current anti-depression medications, psilocybin does not have to be given daily, perhaps only once or twice as in this study.

Marked and sustained improvements in anxiety and anhedonia were also noted. The researchers are now planning a larger randomized controlled trial as the next stage of this promising research. The inclusion of concurrent sessions of cognitive behavioral therapy or mindfulness meditation for some weeks or months during and following psilocybin administration may assist patient with the integration of what they learned during their 'trip treatment'.

Unfortunately the researchers ran into a ridiculous amount of legal red tape which took 32 months between having the grant awarded and treating the first patient since psilocybin is categorized as a Class A illegal drug in the United Kingdom (Schedule I in the United States). In a previous post, I have detailed the rationale for why psilocybin should not be classified as a Schedule I drug. As a brief refresher, the criteria for a compound being listed as Schedule I are:

1. The drug or other substance has a high potential for abuse. Comment: not true for psilocybin. It has shown promising in treating those with substance abuse issues.
2. The drug or other substance has no currently accepted medical use in treatment in the United States. Comment: not true for psilocybin. It is being used by many already but they have to take chances and go it alone without proper medical/spiritual supervision.
3. There is a lack of accepted safety for use of the drug or other substance under medical supervision. Comment: not true for psilocybin. There have been no serious adverse events in the hundreds of patients who have recently taken psilocybin in Clinical Trials.
4. (Unofficial) Because we said so!  Comment: this is the only reason psilocybin is listed as Schedule I as none of the 3 Official criteria are based on rational scientific thought. The reason psilocybin was made and remains Schedule I is purely political. While not a strong advocate of medical marijuana, I do applaud the DEA for currently reconsidering removing it from Schedule I status which will allow the needed research to proceed with less regulatory hurdles. Hopefully they will soon reconsider psilocybin as well. With the billions of dollars at stake, there will be an unprecedented amount of pressure on the DEA not to move psilocybin off of Schedule I status.

Senior author and Neuropsychopharmacologist Dr. David Nutt expressed reasonable displeasure over the 32 month bureaucratic delay stating “Every interaction — applying for licenses, waiting for licenses, receiving the licenses, applying for contracts for drug manufacture, on and on — involved a delay of up to two months. It was enormously frustrating, and most of it was unnecessary,” says Nutt. “The study result isn’t the remarkable part — it’s the fact that we did it at all.”

A thoughtful Commentary (PDF) in Lancet Psychiatry by Dr. Phil Cowen, a depression researcher with the University of Oxford, accompanies the research.

The VA and/or DoD has a primary responsibility towards their patients with PTSD and it is very disconcerting that they are not taking the lead in this very promising research.  Depression and PTSD go hand in hand as the statement below from the Veterans Administration points out:

Many symptoms of depression overlap with the symptoms of PTSD. For example, with both depression and PTSD, you may have trouble sleeping or keeping your mind focused. You may not feel pleasure or interest in things you used to enjoy. You may not want to be with other people as much. Both PTSD and depression may involve greater irritability. It is quite possible to have both depression and PTSD at the same time.

So, lets get going!