- Hi, I'm Dr. Tracey Marks, a psychiatrist,
and I make mental health education videos.
Today, I'm talking about Psilocybin,
also know as magic mushrooms, and how it's on the fast track
as a treatment for depression.
I've talked about treatment-resistant depression before
and what we do about it.
Treatment-resistance occurs when a person's depression
does not resolve with two antidepressant trials.
The current options are to add another medication,
like an antipsychotic medication.
Some of these are medications like Abilify, or Rexulti.
A newer medication for this is Spravato, which is Ketamine.
We also use anticonvulsant therapy
and Transcranial Magnetic Stimulation.
Unfortunately, only about 40 to 60% of people
get completely better with medication,
and for some people, not completely better is tolerable,
but for others, you can still feel pretty miserable
and have a lot of side effects
that you're dealing with, like weight gain.
So, new on the scene is Psilocybin.
Psilocybin is a compound found in mushrooms
that has psychedelic properties.
Psychedelic means that it makes you hallucinate.
Psilocybin works in the brain by activating
the 5HT-2A receptor on the neuron to increase serotonin.
It's been used recreationally for years
and is known to broaden your thinking,
and relax you, and amplify your emotions.
On this issue of broadening your thinking,
there have been studies that have shown
that after only two doses of Psilocybin,
the person was less neurotic and less authoritarian
when it comes to their political views.
Neuroticism is a measure of mental vulnerability
to anxiety and depression.
Authoritarian political views means
that you prefer more government control,
versus libertarianism,
is aligned with freedom from government control.
So, after one to two doses of Psilocybin,
people were more mentally flexible
and less uptight about things.
And the really interesting thing to me about this
is that the attitude changes were seen
seven to 12 months after those one to two doses.
It's not like they had to continue consuming it daily
to maintain this new state of mind.
Here's a little of the history or Psilocybin.
The studies on Psilocybin date back as early as the 1950s.
This led to the approval of the drug Indocybin,
made by Sandoz Pharmaceuticals in 1960.
But it only lasted six years on the market
before it was banned for abuse.
Our society pushed back against the endorsement
of a hallucinogenic drug.
In 1970, Congress passed the comprehensive
Drug Abuse Prevention and Control Act,
which created a classification of drugs based on
their potential for abuse, accepted medical use,
and accepted safety under medical supervision.
They created five classes called Schedules.
Schedule one are drugs that have a high potential for abuse,
no known medical use and lack safety data.
In 1970, Psilocybin and LSD were put in this category.
These drugs can only be used for investigational purposes.
Schedules Two through Five include drugs
that have medical use but still have
a high potential for abuse.
And the lower the number, the higher the abuse potential.
So, for example, Schedule Two drugs include
opioids like Oxycodone, and stimulants like Adderall.
Schedule Three includes ketamine and benzodiazepines,
like Klonopin and Xanax.
Schedule Four includes sleeping medications,
like Ambien.
Schedule Five includes drugs
that have the lowest potential
for abuse or dependence.
And some examples of drugs on this schedule
are Lyrica, Lomotil, which is a diarrhea medication,
and some cough preparations that contain Codeine.
Drugs that are not considered to have any potential
for abuse or dependence are not put on a schedule.
So, not all medications are scheduled drugs.
Antidepressants are examples of medications
that are not scheduled controlled substances.
So, back to Psilocybin.
A renewed interest in Psilocybin began in the 1990s
and these studies showed therapeutic benefit
for people suffering from anxiety,
depression, and alcohol dependence.
Many of these studies used one to two doses
of Psilocybin called Microdosing.
These small studies have accumulated over time,
gaining the attention of large companies
wanting to develop the drug for medical use.
The early results have been so promising
that the FDA granted breakthrough therapy designation
for Psilocybin.
Breakthrough therapy designation allows for a faster track
for drugs to be developed and approved for treatment.
The same thing happened with S-Ketamine,
marketed as Spravato for treatment-resistant depression.
You may be wondering, how long should it now take
that it's on the fast track?
That depends on how long it takes for the trials.
Spravato was granted breakthrough designation
in August 2016, and it was approved to be used
as a drug for treatment-resistant depression in March 2019.
That's two and a half years,
which seems like a long time, but on average,
it takes about 10 years or more for a drug
to go from phase one clinical trials to FDA approval.
So, drugs that show some previous evidence
that it can treat a life-threatening illness
can be pushed through the system faster
so that they can get to market quicker.
There's a real race to get this to market.
The FDA granted breakthrough therapy designation in 2018
to Compass Pathways for treatment-resistant depression
using a range of doses.
Then, in November 2019, the FDA granted
the designation to a company, Usona Institute,
to treat regular depression, not treatment-resistant,
using a single dose.
One dose, and you're good for months?
That would be amazing.
As of the date of this video,
both companies, Usona and Compass Pathways,
are in phase two of four of their clinical trials.
Both companies are still recruiting volunteers.
You can go to their websites to get the details
if you're interested in participating in the trials.
The Compass Pathways trials are being conducted
in Europe and North America.
The Usona trials are only in the United States.
One thing I want to mention
is when it comes to bipolar disorder.
If you've watched other videos that I've made,
you'll know that not all depression is equal.
Depression inside of bipolar disorder
is different from unipolar depression.
Psylocybin is being studied
for the treatment of unipolar depression.
We don't know what effect it will have
on possibly treating or triggering mania or psychosis.
And this doesn't mean that it can't help
with the depression that comes with bipolar disorder,
but we'll first have to see what side effects
are associated with the drug
once they've completed the trials,
to be able to anticipate
how it can affect bipolar disorder.
And even though we don't have a good feel yet
for the side effects and safety issues,
I'm thinking that they're likely to be minimal
because of the microdosing.
That's a limited exposure,
which should produce limited negative effects.
So, this is exciting.
Fingers crossed.
See you next time.