- Treatment-resistant depression affects approximately 30% of people with major depressive disorder.
- A 22-site clinical trial shows that a synthesized version of the psychedelic chemical psilocybin helps reduce symptoms of depression in people with treatment-resistant depression.
- Scientists reported some adverse side effects of this treatment, including suicidal thoughts.
Over the years, researchers have examined the use of
One such psychedelic drug is psilocybin. Previous research shows that psilocybin provides antidepressant effects in people with MDD and reduced depressive symptoms in patients with treatment-resistant depression.
Now a multicentre clinical trial conducted at 22 international sites, including the Institute of Psychiatry, Psychology and Neuroscience (IoPPN) at King’s College London and South London and the Maudsley NHS Foundation Trust, is the largest study to date showing a specific type Psilocybin therapy helps reduce symptoms of depression in people with treatment-resistant depression.
However, researchers did report some adverse side effects of using this psilocybin therapy, including headaches, nausea, dizziness, fatigue, and suicidal thoughts.
This study was recently published in The New England Journal of Medicine.
A person has treatment-resistant depression if their MDD, also known as clinical depression, does not respond to at least two different types of medications that are commonly used to
Signs of treatment-resistant depression include:
- symptoms do not subside after taking prescribed medications for at least 10 weeks
- increased duration and/or frequency of episodes of depression
- brief improvement followed immediately by return of depressive symptoms
- extreme anxiety.
Treatment-resistant depression can occur if a person:
- is naturally resistant to certain antidepressant medications, including
- not staying on your medication for the full prescribed time
- have other health conditions that may affect your depression, such as
heart diseaseeither thyroid problems.
- those with a prior diagnosis of depression
- people who experience
- people taking opioids to treat chronic pain.
Psilocybin is a psychedelic chemical that occurs naturally in certain types of fungi They grow in the United States, South America, and Mexico. That is why they are sometimes called “magic mushrooms”.
“Psilocybin in mushrooms has been
“In the [U.S.] in the
The United States Drug Enforcement Administration (DEA) considers psilocybin to be a program i substancewhich means it is not currently accepted for medical use However, the Food and Drug Administration (FDA) recently approved an investigational new drug application for the use of psilocybin in a eating disorder treatment.
In November 2020, Oregon became the first state to legalize the use of psilocybin under supervision.
“There has been this renewed interest in the use of psychedelic compounds, [with] psilocybin leads the charge,” said Dr. Merrill. “Psilocybin is getting a lot of scrutiny right now for treatment-resistant depression. So it’s really a legal and political question of how much data is enough to get psilocybin legalized given that its efficacy has been well established for decades, if not centuries.”
“Results from trials like this really support the FDA’s indication of use for treatment-resistant depression, which will hopefully spur not only legalization but also eventual coverage by insurance payers like Medicare,” he continued. “In general, commercial health plans tend to follow Medicare decisions. So, in an ideal world, this data would be leveraged to get not only the legalization of psilocybin, but also insurance coverage to improve access.”
During the clinical trial, 233 participants with treatment-resistant depression received a dose of 1 milligram (mg), 10 mg, or 25 mg of COMP360 psilocybin. The participants reportedly received their dose in specially designed rooms to provide a quiet environment.
According to the researchers, the psychedelic effects of psilocybin COMP360 last between 6 and 8 hours. A specially trained therapist accompanied the participants in the room during this time to provide psychological support as needed.
The researchers found that participants who took 25mg doses of psilocybin therapy reported a greater reduction in their symptoms of depression three weeks after treatment, compared to those who took the 1mg dose.
“These findings are a positive step in the right direction,” says Dr James Rucker, Co-Director of the Psychoactive Trials Group at King’s IoPPN and Consultant Psychiatrist at South London and Maudsley NHS Foundation Trust. “Our task now is to investigate psilocybin for treatment-resistant depression in larger trials with more participants, comparing it to both placebo and established treatments.”
The research team also reported a number of Adverse effects among clinical trial participants.
During the 12 weeks of the study, 84% of participants in the 25-mg dose group, 75% in the 10-mg dose group, and 72% in the 1-mg dose group experienced headaches, nausea, dizziness and fatigue.
In addition, participants in all dose groups reported suicidal ideation and intentional self-harm, which the trial investigators say is common in studies of treatment-resistant depression. According to reports, the majority of cases occurred more than a week after the COMP360 psilocybin session.
Dr. Merrill emphasized that these significant side effects show the importance of using psilocybin treatment as a medical treatment:
“It’s not a recreational process, it’s not like do-it-yourself self-help. It really should be done with trained, licensed, or certified professionals who understand the power of these medications to create an altered state of mind. Dissociation, including sometimes hallucinations, [are] part of the psychedelic journey to open the mind to new possibilities, but that journey needs to be backed up with professional help.”
MNT also spoke with Dr Greg Fonzoassistant professor and co-director of the Center for Psychedelic Research and Therapy in the Department of Psychiatry and Behavioral Sciences at the University of Texas Austin Dell School of Medicine, about this study.
He said that while it is currently unclear how psychedelics such as psilocybin exert efficacy for treatment-resistant depression, what potentially makes them an attractive option is the demonstrated ability to exert fast-acting and somewhat long-lasting antidepressant effects for at least a subset of people who undergo this treatment
“Given that people with treatment-resistant depression have already failed multiple trials of evidence-based medication and/or psychotherapy, the possibility of a fast-acting treatment that provides some degree of symptom relief within days of administration lasting several weeks or more is an option worth exploring,” explained Dr. Fonzo.
However, he called the reported side effects “sobering information.”
“Given that suicidal ideation and behavior are already present to some extent in many people with treatment-resistant depression, it is currently unclear whether the rate of these adverse events for psilocybin versus another type of treatment in a similar population would be substantially different. ”, said Dr. added Fonzo.
As for the next steps in this research, Dr. Fonzo said they are already underway and include conducting an even larger multi-site confirmatory efficacy trial in a more diverse population to examine the effect of multiple doses versus single doses, as well as the magnitude of a dose, referring to the amount in milligrams, of psilocybin in the context of the treatment protocol.
It would also “determine whether retreating people who relapse into depression after either no response to a course of treatment or a favorable response that then subsides over time is a strategy that could increase the long-term efficacy of this approach.” , he added. , “and begin to establish the baseline characteristics of the participants that predict a favorable or unfavorable response to this type of treatment.”