2023 experienced many psychedelic studies successes. This is an indication that psilocybin is close to becoming legal for therapeutic use in the following years. The most recent of these psychedelic studies gave results showing that 12 to 15mg of psilocybin for treating depression is a sweet spot for most patients. In most cases, a single dose of psilocybin is enough to create a lasting reduction of symptoms.
Psychedelic studies are rapidly going mainstream again, and it’s only a matter of time for everyone to feel its impact. For instance, MDMA is close to the regulatory finish line, and the accolades for this goes to MAP’s recent new drug application submission. Interestingly, psilocybin isn’t far behind.
The psychedelic studies successes recorded in 2023 is an indication that psilocybin could become therapeutically legal in a few years’ time. In this article, we will take you through some of the most recent psychedelic clinical trials that features psilocybin for depression and provides insight to its efficacy in psilocybin-assisted therapy.
Study Shows Long-Term Benefits of 25mg Psilocybin in Cancer Patients with Depression.
Dr Manish Agrawal led Sunstone Therapies to conduct a phase 2 study with Compass Pathways using COMP360 psilocybin therapy in cancer patients. This mostly included patients with major depressive disorder. It’s worth noting that COMP360 is Compass Pathways synthetic psilocybin extract.
The study was on 30 patients with incurable and curable cancer. These patients were administered with a single 25mg psilocybin dose for depression in them. This was together with individual and group psychological support. The effectiveness of the treatment was evaluated for 8 weeks and 18 months.
Remarkable outcomes were observed in psychedelic-assisted therapy, where a single 25mg psilocybin dose was administered:
After 18 months, more than half of the patients (16 out of 28) maintained remission from their depression. Moreover, 18 out of 28 patients (64.2%) showed consistent clinical improvement from the initial assessment to the 18-month follow-up.
According to Sunstone, this study is considered the most extensive clinical trial on psilocybin therapy, specifically focusing on its impact on depression in cancer patients. The findings of this study were concluded in 2021 and published in April 2023 in JAMA Oncology.
Compass Pathways is building upon this research with their ongoing Phase 3 clinical program, which evaluates the effectiveness of COMP360 psilocybin therapy in treating depression that is resistant to conventional methods. This program stems from the success of Compass’s phase 2b psilocybin study, which was published in the New England Journal of Medicine in November 2022.
(*It is important to note that 25 mg of psilocybin extract is approximately equivalent to 2.5 grams of dried mushrooms, assuming each gram contains about 1% psilocybin. The potency can vary between .5 to 2%.)
Antidepressants Combined with Single Psilocybin Dose Yields Successful Results
Compass Pathways conducted a Phase 2 exploratory study this year to investigate the combined use of psilocybin and SSRIs. The study included nineteen patients who received a 25mg dose of psilocybin for depression, along with psychological support and daily SSRIs.
The findings of the study showed that 42% of the participants experienced a clinical response and remission at week three when treated with COMP360 psilocybin and SSRIs for treatment-resistant depression. The treatment was generally well-tolerated, with the most common side effect being headaches. No serious adverse outcomes were reported.
These results suggest that SSRIs may not interfere with the therapeutic effect of COMP360 psilocybin. Therefore, patients may not need to discontinue their SSRI antidepressants in order to benefit from psilocybin treatment.
In August 2023, the Usona Institute, a non-profit medical research organization, published the results of its Phase 2 clinical trial. The study included 104 participants who received a 25mg dose of psilocybin combined with 20 hours of talk therapy for depression. The results were positive, consistent with the Institute’s previous trials.
The treatment with psilocybin and talk therapy significantly reduced depressive symptoms in adults with major depressive disorder (MDD), demonstrating both rapid and sustained effects. The treatment also led to a notable decrease in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to day 43, indicating a persistent antidepressant effect. Psilocybin was well-tolerated, with no serious adverse events reported.
Usona Institute is currently progressing towards a Phase 3 clinical trial with psilocybin.
If both Usona and Compass Pathways successfully complete Phase 3 trials, the FDA could potentially approve the use of therapeutic psilocybin by 2027.
Double Psilocybin Dose for Depression Shows 79% No Longer Need Treatment
Earlier this year, Cybin, a biopharmaceutical company, announced the interim results of a Phase 2 trial involving synthetic psilocybin (CYB003) as a treatment for Major Depressive Disorder. The results indicated that a single dose of psilocybin had a significant impact on reducing depressive symptoms, surpassing the effectiveness of traditional antidepressants within three weeks.
Recently, Cybin shared additional data from their study highlighting the advantages of administering a second dose of psilocybin for depression. Upon receiving a single 12mg dose, participants experienced a notable reduction of -14.08 points on the MADRS score after three weeks, with 20% of them achieving remission. Remarkably, after six weeks and two 12mg doses of psilocybin, the rate of depression remission elevated to 79%.
Furthermore, the study examined the effects of a single 16mg dose of psilocybin, which demonstrated similar significant effects on depression. It is worth noting that CYB003 exhibited a favorable safety profile, with some participants experiencing mild and self-limiting adverse events.
These findings strongly indicate the potential of CYB003 as an effective treatment for depression, thereby justifying the need for further investigation in a Phase 3 study.
First-Ever Clinical Trial Explores 25mg Psilocybin for Bipolar Disorder
Dr. Scott Aaronson from Sheppard Pratt Hospital conducted a groundbreaking study on the use of psilocybin for bipolar II depression. The study involved 15 bipolar patients who were administered a dose of 25mg of psilocybin, after ceasing the use of pharmaceutical medications for two weeks. The treatment also included therapy sessions before, during, and after the use of psilocybin.
The study’s main objective was to observe the impact of psilocybin on the severity of depression, measured using the Montgomery-Åsberg Depression Rating Scale (MADRS). Results showed that twelve participants met the clinical response criteria, experiencing a significant decrease in depression severity without any significant negative side effects.
Additionally, the study followed up with the patients after twelve weeks, finding that eleven of them remained in remission without an increase in manic or hypomanic episodes, symptoms, or suicidal thoughts.
These findings offer renewed hope for individuals suffering from bipolar II disorder, a challenging and challenging-to-treat condition.
Pioneering Clinical Study Reveals Psilocybin Therapy’s Impact on Anorexia Treatment
The initiative to study psilocybin assisted therapy for anorexia was led by Drs. Walter Kaye and Stephanie Knatz Peck from UC San Diego School of Medicine, as reported in a recent publication by Nature Medicine. The study was conducted in an open-label format.
This groundbreaking study aimed to explore the impact of a solitary COMP360 psilocybin session on ten female individuals suffering from anorexia. Prior to the session, all participants gradually reduced their intake of SSRIs and took part in preparatory sessions to better navigate the journey.
On the designated day, the patients were administered a dosage of 25mg of psilocybin while receiving psychological support for a duration of eight hours. Subsequent evaluations took place the following day, one week later, one month later, and at three-month intervals.
The findings revealed significant decreases in symptoms related to the eating disorder following a single 25mg dose of psilocybin.
At the three-month mark, 40% of the test subjects displayed notable reductions in eating disorder psychopathology. Furthermore, there were statistically significant decreases in concerns regarding body shape and weight. While five participants experienced an increase in BMI, the changes were not deemed statistically significant.
The treatment was well-tolerated, with participants only experiencing mild and fleeting adverse effects. In addition, the individuals perceived the psilocybin experience as meaningful, leading to positive transformations in personal identity and overall quality of life.
Largest Ever Survey of Naturalistic Psilocybin Use Finds Abundance of Benefits
A recent study published in Frontiers in Psychiatry discusses the impact of psilocybin use in natural, non-clinical settings. Led by Matthew Johnson from Johns Hopkins, the research team collected data from 2,833 individuals over a period of 24 months. These participants were primarily educated white men from the United States who consumed an average of 3.1 grams of dried mushrooms. Before and after their psilocybin experiences, the respondents completed questionnaires.
The survey analysis revealed that the participants experienced long-lasting improvements in their mental health, cognitive flexibility, and overall well-being. Journeyers reported reduced levels of depression, anxiety, and alcohol misuse that persisted over time. Furthermore, their cognitive flexibility and emotional regulation showed improvement, and they even reported feeling more spiritual and extraverted.
Nevertheless, a minority of participants reported experiencing adverse effects that persisted after their psilocybin journey. Approximately 11 percent experienced mood fluctuations and depressive symptoms for two to four weeks. Also, seven percent reported these symptoms lasting two to three months.
These findings highlight the nuanced effects of psychedelics. These effects can vary depending on factors such as dosage, setting, medical history, and emotional state.
Study Compares 25mg Psilocybin Dose and Escitalopram for Major Depressive Disorder
Researchers from Johns Hopkins University conducted a groundbreaking study, published in Cambridge University Press. This study compared psilocybin-assisted therapy to the commonly used antidepressant escitalopram for treating major depressive disorder.
During a six-week trial, 59 patients were observed for changes in personality traits such as neuroticism, introversion, and impulsivity. The group undergoing psilocybin therapy (PT) received a 25mg dose of COMP360 synthetic psilocybin. On the other hand, the escitalopram group received 1 mg of psilocybin followed by escalating doses of escitalopram.
Both groups had a second session three weeks later, with the PT group receiving another 25mg psilocybin dose and the escitalopram group taking 1 mg of psilocybin and an increased daily dose of 20 mg of escitalopram. All patients received psychological support and assessments at the sixth week and a six-month follow-up survey.
The results of the study revealed that both psilocybin-assisted therapy and escitalopram treatment led to positive changes in personality. Psilocybin therapy resulted in lower levels of neuroticism, introversion, disagreeableness, and impulsivity, while increasing levels of openness and absorption.
Escitalopram therapy also led to reductions in neuroticism, impulsivity, and disagreeableness, along with an increase in openness. Psilocybin was particularly effective in reducing non-planning impulsivity and disagreeableness, which are associated with depression and its related dysfunctions. These personality changes, particularly in neuroticism and openness, were maintained for up to six months after the intervention.
Although the researchers had expected to see a larger difference in outcomes between psilocybin and the antidepressant, the findings still indicated that psilocybin therapy could be a valid alternative to SSRIs for treating depression. It offers advantages such as avoiding long-term medication use and the related side effects.
Psychedelic Studies Links Psilocybin to Reduced Distress in People with Childhood Adversity
A recent study in the Journal of Psychoactive Drugs found a link between psilocybin and decreased distress. This connection might be evident to those familiar with the field of psychology. However, it further supports the idea that childhood trauma can lead to various mental health issues later in life.
The study focused on the relationship between psilocybin and psychological distress, specifically examining Adverse Childhood Experiences (ACEs). This includes abuse, neglect, and exposure to violence. Researchers collected information on participants’ demographics and their history of using psilocybin. This also includes how often they consumed it, the dosage, and their intentions behind using it.
The findings revealed that individuals who had consumed psilocybin within the past three months experienced lower levels of psychological distress. This was for those who had a history of adverse childhood incidents. Furthermore, participants reported positive views on the benefits and safety of psilocybin.
Analysis Reveals Psilocybin Dose is a Major Factor in Influencing Journey Intensity
Researchers at King’s College London recently conducted a crucial study on psilocybin therapy. This was to identify factors that enhance mystical and challenging experiences during psilocybin sessions. The study aimed to improve the effectiveness of psychedelic medicine.
In this study, 89 healthy volunteers were involved in a Phase 1 clinical trial. They were divided into three groups, with one group receiving a placebo, and another group receiving 10 mg of psilocybin. The third group received 25 mg of psilocybin for depression. Through statistical analysis, the researchers analyzed the impact of different dosages on the participants’ experiences. In addition to dosage effects, the study also examined the role of personality traits, emotional state, and individual outcomes.
The findings revealed that dosage was the most significant factor influencing the experiences.
Higher doses of psilocybin resulted in more intense mystical and challenging experiences. Older participants reported less intense challenging experiences compared to younger participants. Neuroticism was found to positively correlate with the intensity of challenging experiences, but only at higher doses of psilocybin. The study did not find any significant correlation between positive or negative emotional states. It also didn’t find a correlation between the intensity of mystical or challenging experiences.
Although this study is exploratory in nature, it represents a significant advancement in psilocybin therapy. This is by providing insights into the importance of dosage, age, personality traits, and emotional state. This information empowers practitioners and patients to better prepare for safe and effective journeys during psilocybin therapy.