NCT06141876

Evaluation of Psilocybin-Assisted Psychotherapy in Treating Severe Depression in Patients With PTSD

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of Psilocybin-Assisted Psychotherapy in Treating Severe Depression Among Adults With Post-Traumatic Stress Disorder (PTSD).

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Apex Labs Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post-traumatic Stress Disorder
• Depression

Interventions

Type	Name	Description
DRUG	APEX-002-A02	Active
OTHER	Placebo	placebo

Timeline

• Start date: 2023-12-15
• Primary completion: 2025-06-15
• Completion: 2025-06-15
• First posted: 2023-11-21
• Last updated: 2023-11-29