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NCT06442423 · ClinicalTrials.gov registry record · Phase 1
Open-Label Psilocybin Study in Transdiagnostic Population
A Phase 1 study of Anxiety and PTSD, sponsored by Yale University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT06442423: Recruiting Phase 1 study of Anxiety and PTSD, sponsored by Yale University.
NCT06442423 is a Phase 1 study of Anxiety and PTSD that is actively recruiting participants, run by Yale University. The registered enrollment target is 50 participants, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06442423, a Phase 1 study of Anxiety and PTSD, is actively recruiting participants, sponsored by Yale University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of this study is to investigate the safety, feasibility, and tolerability of psilocybin treatment in individuals with functional impairment due to psychiatric symptoms. The secondary objective of this study is to determine whether individuals with functional impairments due to psychiatric symptoms will experience statistically significant symptom reduction and functional improvement from baseline symptom measurements (Visit 3) to 1-week (Visit 7), 4-weeks (Visit 8), and 6-weeks (Visit 9) post dosing. The investigators will recruit individuals with mood, anxiety, trauma, addictive, or related symptomatology, and who have functional impairment associated with these symptoms. A DSM-5 diagnosis is not required (nor is it an exclusion). The investigators will allow for comorbidity and only exclude based on psychological and physiological safety considerations. Critically, this approach will allow us to assess the tolerability of our interventions in individuals who would typically be excluded from efficacy studies due to various comorbid DSM-5 conditions. The investigators will employ an open-label study where participants will be given one dose of oral psilocybin 25mg. The investigators will also have follow-up visits at 1, 4, and 6 weeks and an optional long-term follow-up at 3, 6, and 12 months.
Primary Outcome
Range 0 to 25, higher score indicating more suicidal risk
Conditions Studied
Interventions
- DRUG Psilocybin
Study Locations (1)
Connecticut
- Connecticut Mental Health Center - Yale School of Medicine - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2024-10-17 |
| Est. Completion | 2027-12 |
| Phase | Phase 1 |
What NCT06442423 shows while recruiting
NCT06442423 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (89% lower).
The record links to 8 conditions, with Anxiety appearing as the primary indexed condition, and to 1 intervention - of which Psilocybin is the first listed.
NCT06442423 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT06442423 about?
NCT06442423 is a clinical study titled "Open-Label Psilocybin Study in Transdiagnostic Population". The primary objective of this study is to investigate the safety, feasibility, and tolerability of psilocybin treatment in individuals with functional impairment due to psychiatric symptoms. The secondary objective of this study is to determine whether individuals with functional impairments due to ...
What is the current status of trial NCT06442423?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2024-10-17. Estimated completion is 2027-12.
What conditions does trial NCT06442423 study?
This clinical trial studies the following conditions: Anxiety, PTSD, Substance Use, Depression - Major Depressive Disorder, OCD.
What interventions are being tested in trial NCT06442423?
The interventions under investigation include: Psilocybin (DRUG).
Who is sponsoring clinical trial NCT06442423?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06442423 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Anxiety
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06442423's enrollment target sits among peer trials
50 246th of 364 higher than 110 of 364 other Anxiety trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anxiety trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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