Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06442423
The ClinicalTrials.gov registry entry for NCT06442423 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (89% lower). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
-
Use of a Generative AI (Gen-AI) Chatbot for Anxiety and Depression Among Persons With Cannabis Use
RECRUITING · Phase 1
-
The Impact of Focused Ultrasound Thalamotomy of the Anterior Nucleus for Focal-Onset Epilepsy on Anxiety
RECRUITING · Phase 1
-
Autonomous Digital CBT Intervention for Opioid Use Disorder in Individuals With Co-Occurring Internalizing Disorders
ACTIVE NOT RECRUITING · Phase 1
-
Transforming Psychotherapy for Chronically Ill Patients
COMPLETED · Phase 1
-
Patient-Controlled Anxiolysis With Dexmedetomidine (PCA-DEX) for Burn-care Dressing Changes
COMPLETED · Phase 1
-
Bright Light: A Novel Treatment for Anxiety
COMPLETED · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.