Evaluation of Psilocybin-Assisted Psychotherapy in Treating Severe Depression in Patients With PTSD
Status:
Not yet recruiting
Trial end date:
2025-06-15
Target enrollment:
Participant gender:
Summary
Post-Traumatic Stress Disorder (PTSD) is a mental disorder that may develop in people who
have been exposed to a traumatic event, including actual or threatened death, serious injury,
or sexual violence. Exposure to a traumatic event is defined as directly experiencing the
event, learning about the event, or repeated exposure to details of the event. PTSD is often
accompanied by other psychiatric and physical comorbidities, both of which are associated
with elevated healthcare costs. Depression, psychosis and suicide rates are consistently
reported in greater proportion of PTSD patients. Despite the overwhelming impact of PTSD and
comorbid depression, there is a shortfall of effective treatments with few side effects that
target the broad range of symptoms, including depression.
Psilocybin has been studied for the treatment of depression, anxiety, tobacco and alcohol use
disorders, obsessive-compulsive disorder, end of life depression and anxiety, demonstrating
safety and efficacy for a variety of indications, with no significant adverse events
occurring during the course of treatment and follow-up. Notably, in a participant group
distinguished by long-standing, moderate to severe major depressive disorder, two doses of
psilocybin-assisted therapy were found to be as effective in antidepressant effects as 6
weeks of daily escitalopram, a commonly used SSRI. Promising results found in these studies
have led to psilocybin recently receiving breakthrough designation from the US FDA for its
potential therapeutic effect in the treatment of depression.
Based on previous research, psilocybin has demonstrated a favorable safety profile and has
shown preliminary efficacy against depression as well as other symptoms that typically affect
patients with PTSD. Unlike traditional SSRIs which are associated with treatment-resistance
and addiction, psilocybin requires few doses to improve a wide-range of symptoms and has not
been linked with physical dependence. Furthermore, the effect of other psychedelics can vary
greatly and may potentially exacerbate existing conditions.