Psilocybin hailed as ‘potential breakthrough’ for depression among patients with cancer
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Key takeaways:
- Psilocybin effectively lowered depression symptoms in patients with cancer in a group therapy setting.
- Half of trial participants showed total remission of depression symptoms after 8 weeks.
Psilocybin significantly reduced depression symptoms in patients with cancer, results from a phase 2 study published in Cancer showed.
Additionally, half of the participants displayed complete remission of their depression symptoms over the 8-week trial period.
Psilocybin, a hallucinogenic chemical found in specific mushrooms, is a schedule I drug and not approved by the FDA.
In a concurrent qualitative study also published in Cancer, many of the participants verbally reported positive experiences regarding both the safety and therapeutic benefits of the psilocybin trial.
The study’s group setting helped patients connect to one another and feel comfortable with a treatment that multiple individuals said they had concerns about prior to starting.
“The group approach, as demonstrated in our trial, adds a unique dimension to the therapeutic process,” Yvan Beaussant, MD, MSc, instructor at Harvard Medical School and physician at Dana-Farber Cancer Institute, told Healio.
“The structured setting, combined with individual and group sessions, not only enhanced the overall experience but also fostered a sense of togetherness and support among participants,” he added. “These findings suggest a promising avenue for addressing the psychological burden of cancer, although further research is necessary before widespread implementation.”
Roughly 25% to 33% of patients with cancer have clinically significant depressive symptoms, but success of antidepressants is limited, and side effects can delay medical benefits of cancer treatment, according to background research provided in the studies.
“As an oncologist and palliative care physician, I witnessed the limitations of conventional treatments in addressing the holistic well-being of patients,” Beaussant said.
Psilocybin proved effective as an antidepressant in other clinical trials, but those studies used an individualized treatment approach due to concerns of the psychedelic nature of the drug.
Phase 2 psilocybin trial
Participants needed to have a cancerous tumor, a major depressive disorder, be aged at least 18 years and not taking cannabis, antidepressant or antipsychotic medications.
The trial, which spanned 8 weeks with eight total visits, included 30 individuals (70% women; 80% white; 70% received at least one cancer therapy; 50% had used antidepressants).
Clinicians divided study group into eight cohorts of three to four participants. They had individualized and group sessions prior to the treatment.
Participants received a 25 mg dose of psilocybin with their fellow group members and stayed at the facility for 8 hours, being monitored with a 1:1 therapist-to-patient ratio.
Montgomery-Asberg Depression Rating Scale scores fell 19.1 points from the beginning of the trial to the end (95% CI, –22.3 to –16; Cohen d = 2.55). Participants also had a rapid response to therapy, as scores dropped by an average of 17.8 points by week 1 (SE, 1.27; Cohen d = 2.38) and 19.2 by week 3 (SE, 1.44; Cohen d = 2.52).
Clinicians observed 80% of participants maintained the positive effects of treatment, 50% had full remission by week 1 lasting through week 8.
Hamilton Anxiety Rating Scale scores dropped by an average of 17 (95% CI, –19.7 to –14.4; Cohen d = 1.78), self-reported state anxiety scores on the Spielberger State-Trait Anxiety Inventory (STAI) fell by a mean of 17.2 (95% CI, –21.7 to –12.6; Cohen d = 1.35) and trait anxiety numbers on STAI also lowered by an average of 17.2 (95% CI, –22.2 to –12.1; Cohen d = 1.13).
“The results ... were truly promising and exceeded our expectations,” Beaussant said. “Witnessing a substantial reduction in depressive symptoms among participants, with an 80% sustained response and 50% achieving full remission, was both remarkable and unexpected. The positive impact endured for 8 weeks, indicating a potential breakthrough in addressing the psychological challenges faced by individuals with cancer.”
Qualitative study results
Of the 30 individuals in the phase 2 trial, 28 agreed to be in the secondary study to determine how they felt the trial went.
Beaussant interviewed participants within 2.9 months of receiving psilocybin. The discussions lasted an average of 90 minutes.
Responses to the psilocybin therapy included feeling safe and well-cared for with the treatment after initial trepidation, connection with fellow participants, fulfillment with the trial thanks to post-dose group therapy, compassion for others and a positive outlook on the individual sessions.
Negative responses included being distracted by other patients and questions about whether different group constructs could be more beneficial.
“The positive impact reported by participants underscores the importance of a supportive, structured setting in which the therapy takes place,” Beaussant said.
He stressed this trial should be considered a steppingstone to further research because there are many questions that still must be answered.
“While our study shows promise, future research should focus on larger cohorts and include a control arm for a more comprehensive understanding of psilocybin-assisted therapy's efficacy,” he said.
“Exploring its comparative effectiveness with existing treatments or placebos will contribute to establishing its place in clinical practice,” Beaussant added. “Additionally, the long-term effects and potential applications of this therapy for the distress experienced by cancer patients beyond depression merit further investigation.”
References:
Agrawal M, et al. Cancer. 2023;doi:10.1002/cncr.35010.
Beaussant Y, et al. Cancer. 2023;doi:10.1002/cncr.35024.
For more information:
Yvan Beaussant, MD, MSc, can be reached at yvan.beaussant@dfci.harvard.edu.
Perspective
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Kyle Neale, DO
Let’s not bury the lede: A single dose of psilocybin combined with group and individualized therapy resulted in significantly lower depressive symptoms among patients with cancer, notably with half of participants categorized as being in remission at 8 weeks. This paper builds upon other evidence reporting similarly improved depressive symptoms among patients with cancer who received psilocybin-assisted therapy.
The momentum of these results is encouraging because our available interventions have not shown such significant impact in an unfortunately common condition. There is low-quality evidence suggesting psychotherapy can mildly to moderately reduce depressive symptoms among patients with cancer. Similarly, antidepressant use may be superior to placebo, but quality of available studies is low, with significant heterogeneity and without evidence for long-term benefit beyond 12 weeks, according to a recent Cochrane review.
There is urgency for improved treatments because of depression’s impact on patients with cancer. It worsens quality of life, reduces treatment adherence and is associated with poorer survival.
Granted, the available evidence for psilocybin is not yet robust. Study size is small, frequently underpowered as in this study, and with difficult blinding given the nature of psychedelic therapy. However, the magnitude and duration of the response is inspiring. Other studies have shown benefit as far as 6 months following one dose.
It is not yet clear how much of the benefit can be directly attributed to psilocybin effects or to the therapy sessions. Further research is needed to clarify the role of “set and setting,” or mindset approaching treatment and the physical and emotional environment in which patients receive therapy. The notable contribution from this study is the potential scalability. Prior positive research used therapists in a one-to-one protocol; this report showed that group therapy in a community oncology practice may be as effective, which will improve access to care.
I am concerned that society is moving toward acceptance of psilocybin and other psychedelics faster than the evidence supports; these drugs are not without potential harm. But outcomes from use in a structured, supervised therapeutic setting like this protocol gives patients, clinicians and caregivers hope for a brighter future.
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