Will the FDA approve this life-changing and life-saving frontier of mental health?

Post Traumatic Stress Disorder, or PTSD, affects 13 million Americans and there are very few tools in the psychiatric therapy or medication management toolbox to effectively treat the condition. But recently there have been very promising results using psychedelic drugs that have seen up to an 80 percent remission rate for PTSD.

MDMA and its Fight for Rescheduling

Because of these staggering results, there has been a groundswell of support from mental health professionals, military, first responders, and veterans advocacy organizations, and both democratic and republican lawmakers to advance the approval of these drugs for psychiatric use. The company Lykos Therapeutics has been spearheading a study using MDMA in conjunction with intense integrative psychotherapy in an effort to get MDMA rescheduled to a three or four by the Food and Drug Administration (FDA). This would allow licensed and trained therapists, like the ones at Mind and Body Counseling, to use MDMA in a therapeutic setting to treat PTSD and other chronic cases of anxiety and depression.

Unfortunately a key FDA advisory committee rejected the use of this psychedelic drug to help patients struggling with PTSD, questioning its safety and effectiveness.

Now, on August 11th, the FDA must decide whether it will follow suit and reject the use of MDMA, or if it will reschedule the drug for therapeutic use. Historically, the FDA follows the advisory committee 88 percent of the time. However, when they do break from the advisory committee, it is usually in favor of approval. Because of the tremendous bipartisan support of this treatment, the outstanding results for patients with PTSD, and the unified championing of MDMA from the mental health community, there is high hopes that the FDA will see the overwhelming evidence and approve the drug.

Why is PTSD so Devastating?

PTSD is often associated with veterans. $232.2 billion is the estimated annual cost of PTSD in the United States (2018) among all U.S. civilians, active-duty military personnel, and veterans. While it definitely affects veterans and first responders, PTSD can happen to anyone who has had a severe trauma response. This could have happened in childhood, as a result of an abusive relationship, the loss of a child, a severe accident, the list goes on. A quote from Paul Conte, MD says that, “Trauma is an event(s) that fundamentally changes the way our brain works for the worse. Every bad event that occurs is not trauma, but if it changes: thoughts, behavior, emotional tone that are not adaptive for us, then it is trauma.”

What we do know is that PTSD is very hard to recover from, and psychedelic drugs are the only thing we have found to have a significant impact and long term remission.

PTSD Facts:

  • Half the number of people with PTSD who undergo therapy achieve no long-lasting relief.
  • Prescription therapy (often SSRI’s) can have limited effects only 40-60% get some symptom relief
  • SSRI and quality talk therapy can improve outcomes, but not significantly and rarely full remission is obtained
  • 65% of People with PTSD have comorbidities: depression, anxiety, substance abuse, etc.

Medicines Used in Psychedelic Assisted Psychotherapy

  1. MDMA – Not Approved (YET!), Schedule 1 – shown in studies to be highly effective in a variety of physiological conditions including anxiety, depression and PTSD
  2. Psilocybin (aka “magic mushrooms”) – Not Approved, Schedule 1 – shown in studies to be highly effective in a variety of physiological conditions including anxiety, depression and PTSD
  3. Ketamine – Approved – highly regulated

How MDMA Therapy Works for PTSD

MDMA stands for methylenedioxymethamphetamine, and is a psychoactive stimulant that invokes feelings of empathy, self-awareness, and ability to open up about emotions. MDMA increases your levels of serotonin, dopamine and norepinephrine, and provides a safe space for you to revisit trauma, triggering events, or experiences from your past that are otherwise hard to discuss. By tapping MDMA’s effects on our brain, we can delve far deeper to help heal your root trauma and pain points than with talk therapy alone.

MDMA therapy can be used to treat depression, anxiety, and PTSD, and this method has shown faster relief and longer lasting results than talk therapy alone. Researchers see more benefits with MDMA therapy than any other psychotherapy or medication currently being used to treat PTSD.

How Psilocybin Works in Therapy

Psilocybin mushrooms are used as a mental health treatment to help patients overcome mental health obstacles faster than talk therapy alone. The session is facilitated in a controlled setting and administered by specialty-trained therapists. Clinical trials for the treatment of depression, anxiety, substance abuse are on-going and we speculate this information will be submitted to the FDA for rescheduling and approval for clinical use in 2025-26.

Psilocybin, the active ingredient in certain mushrooms, allows our brain’s neural pathways to connect in a more open, less structured way. It increases serotonin levels in the brain and is similar chemically to serotonin. The experiences also help us to focus inward. Through this unique stream of consciousness, our brains develop new understanding of past experiences or novel ways of approaching blocked thought or behavior patterns. It increases 5HT-2A receptors which creates what people will describe as “mystical experiences”.

Especially beneficial for those resistant to treatment, such as a psychotherapy/medication approach, psilocybin therapy shows marked results for patients who experience anxiety and depression, post traumatic stress disorder (PTSD), addiction and obsessive thinking. Studies show 65 percent of patients saw improvements in their anxiety, and the majority of those with depression noticed improvement or even remission after psilocybin therapy. It is important to note that the substance alone without treatment “integration” does not create changes in one’s mental health.

Ketamine’s Use in Therapy

Ketamine therapy has shown fast-acting, effective improvements in patients with severe PTSD who don’t have success with traditional medications. While scientists are still exploring ketamine’s effects, we believe the psychedelic experience allows lost synapses (brain connections) to regrow as well as create new neural pathways. Over the long term, patients report improved mood, behavior, and motivation.

The biochemical actions of Ketamine supports and promotes increased neuroplasticity through:

  • Dendritic neurogenesis (growth of dendrites)
  • Decreased apoptosis (cell death)
  • Manages inflammatory cytokines (by blocking pro-inflammatory cytokines) which can improve healing.

Ketamine shows a profound effect on treating mental health concerns such as depression, pain, and substance use disorder. While traditional medication for treating anxiety and depression work to correct neurochemical imbalances such as serotonin or dopamine with a daily medication, ketamine therapy is a different mechanism entirely. Research shows high rates of success in treating depression, with more than 50 percent of patients noticing symptom relief immediately following treatment, as well as lasting symptom remission.