Safety, Tolerability, Outcomes of Psilocybin for Depression (STOP Depression) in Veterans with SCI
Background
There is a high prevalence of depression in the SCI population; however, members of the SCI community have been left out of psychedelic research studies. Psilocybin belongs to a class of drugs called psychedelics. Psilocybin is produced in nature by some species of mushrooms and has been designated a breakthrough therapy for major depressive disorders by the Food and Drug Administration (FDA). This study will evaluate the safety and therapeutic potential of psilocybin for the treatment of depression in Veterans with spinal cord injury (SCI). Under the leadership of Dr. Jill Wecht, participants with chronic SCI will receive one of three psilocybin doses and will be followed longitudinally for up to one year. Outcomes will include safety and tolerability, depressive symptoms, pain, muscle spasticity, and quality of life. The goal is to determine whether psilocybin can provide a safe and effective treatment for depression in individuals with SCI and to challenge the assumption that depression is an unavoidable consequence of spinal cord injury.
PURPOSE
To determine the safety and possible benefits of psilocybin to treat depression, pain, spasms, quality of life,
STUDY REQUIREMENTS
- Screening and baseline assessments (up to 1 month)
- Psilocybin-Assisted-Therapy (up to 1 month)
- Three preparatory sessions
- One experimental session
- Three integration sessions
- Follow-up assessments (12 months)
- Three in-person visits
- Five remote visits
ARE YOU ELIGIBLE?
Remote Screening
- 1.AGE: Older than 21 years
- 2.Chronic SCI: more than 1 year
- 3.Depression: more than 3 months
- 4.Weight: more than 110 lbs.
- 5.Understand and speak English
In-person Screening
.Medical exam
- 1.Heart conditions
- 2.Prescribed medications
- 3.Drug use
- 4.Pregnancy
Psychological exam
- 1.Psychiatric conditions
- 2.Suicide risk
- 3.Depression severity
Investigator
Jill Wecht, EdD
Study ID
Contact
Wenjie Ji and Genevieve Curtis
Clinicaltrials.gov Identifier
NCT05163639
