Study Details

Open

Treatment-Resistant Depression Study

This is an open label pilot study comparing 20 people with TRD to receive one or two sessions of psilocybin-assisted therapy (10 in each group). We will measure the change in depressive symptoms between your first visit and the 2 weeks following psilocybin-assisted therapy in both groups. We will also measure the changes in depressive symptoms between your first visit, 6 weeks, 3, 6, 9 and, 12 months following the one or two doses of psilocybin-assisted therapy.

Age & Gender

18 years ~ 70 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

You will receive your regular treatment during this study. You will have a screening visit to determine if you are able to take part. You will be assigned to one or two psilocybin assisted therapy sessions. You will receive education before treatment. Your monitored psilocybin-assisted therapy sessions will be 8 hours and you must transported home by an adult. You will receive follow up consolidation therapy. At each follow up visit you will have clinician-performed and self-rated measures of depression. These will occur at 2 weeks, 6 weeks, 3, 6, 9, and 12 months after treatment.

In-person visits:
9

Phone or online visits:
7

Total length of participation:
12 months

Looking for Specific Volunteers

Able to participate:

Currently experiencing a major depressive episode, lasting at least 3 months
Failure to respond or inability to tolerate at least 2 antidepressants
Have not tolerated the side effects two antidepressants
Identified support person to accompany patient home after dosing

Not eligible if:

Personal/family history of psychosis, schizophrenia, schizoaffective disorder, bipolar disorder with psychosis, hallucinogen-induced psychosis, borderline or antisocial personality disorder
In the previous 12 months: moderate/severe alcohol/other drug use disorder (including nicotine)
Current active suicidal ideation or suicidal behavior or current active self-injurious behavior
Current pregnancy or lactation
Severed medical problems: hepatic, renal, circulatory, cardiac (arrhythmia, uncontrolled hypertension, pulmonary or CNS disorder

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

NC Neurosciences Hospital
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Robert McClure
Psychiatry - General

Study Type

Clinical or Medical
Interventional

Study Topics

Mental and Emotional Health

IRB Number

22-1421