NCT06141876: SUMMIT-90

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

Status unknown Phase 2 Last updated 29 November 2023

What this trial tests

Phase 2 trial testing APEX-002-A02 in Post-traumatic Stress Disorder in 160 participants. Status unknown.

Timeline

15 December 2023

Primary endpoint
15 June 2025

15 June 2025

Quick facts

Lead sponsor	Apex Labs Ltd.
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	160
Start date	15 December 2023
Primary completion	15 June 2025
Estimated completion	15 June 2025

Drugs / interventions tested

• APEX-002-A02 — full drug profile →
• Placebo

Conditions studied

• Post-traumatic Stress Disorder — all drugs for Post-traumatic Stress Disorder →
• Depression — all drugs for Depression →

Sponsor

Apex Labs Ltd. — full company profile →

Who can join

Adults 18 to 65, any sex, with Post-traumatic Stress Disorder or Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.