Psilocybin-Assisted Therapy in Treatment-Resistant Depression (NCT06303739) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Psilocybin-Assisted Therapy in Treatment-Resistant Depression
United States20 participantsStarted 2024-04-19
Plain-language summary
The goal of this clinical trial is to test how well psilocybin-assisted therapy works in treating people with depression. The main questions this study aims to answer are:
* Does psilocybin with assisted therapy help improve symptoms for people with depression?
* How long do the effects of this treatment last?
Participants will:
* Take part in a couple of screening and preparation visits.
* Be given psilocybin in one or two treatment sessions.
* Attend a series of follow-up sessions over the following year.
* Complete forms and surveys to test how their symptoms have changed and what they thought of their experience.
Researchers will also compare whether one treatment or two treatments help improve symptoms more for participants.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Provision of signed and dated informed consent form.
* Willingness to comply with all study procedures and availability for the study.
* Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-V) diagnosis of major depressive disorder.
* Currently experiencing a major depressive episode, lasting at least 3 months
* Failure to respond or inability to tolerate at least 2 guideline-concordant pharmacological treatments from different pharmacologic classes during the current major depressive episode
* Good health evidenced by medical history and routine lab tests
* No central nervous system (CNS) or neurocognitive impairment
* Ability to take oral medication and to follow to the psilocybin-assisted therapy protocol
* Identified support person to accompany patient home after dosing
* Use of effective contraception throughout the study by those with child-bearing potential
* Use of condoms or other effective contraceptive methods by males with reproductive potential
* Fully vaccinated and up to date on vaccination against COVID-19, as defined by Center for Disease Control guidelines
* Following Lifestyle Considerations throughout study (no nicotine containing products in clinical unit, refrain from operating heavy machinery for the duration of treatment day, no more than two servings 8 hours prior to treatment, no psychoactive drugs 72 hours before treatment, refrain from consuming foods that would interfere with drug absorption, minimize interaction wit…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in HAM-D-17 Scores between Baseline and 2 Weeks after Treatment
Timeframe: Baseline, 2 weeks
2
Change in QIDS SR-16 Scores between Baseline and 2 Weeks after Treatment
Timeframe: Baseline, 2 weeks
3
Number of Participants Achieving Remission 2 Weeks after Treatment
Timeframe: up to 2 weeks
4
Number of Participants Achieving Response 2 weeks after treatment