Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT06512194 · ClinicalTrials.gov registry record · Phase 2

Investigation to Understand and Optimize Psilocybin

A Phase 2 study of Depression, sponsored by Charles Raison.

Recruiting
Registry status
Phase 2
Development phase
141
Enrollment target
1
Study location

NCT06512194: Recruiting Phase 2 study of Depression, sponsored by Charles Raison.

NCT06512194 is a Phase 2 study of Depression that is actively recruiting participants, run by Charles Raison. The registered enrollment target is 141 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT06512194, a Phase 2 study of Depression, is actively recruiting participants, sponsored by Charles Raison.

RECRUITING
Registry status
Phase 2
Development phase
141 participants
Enrollment target
1
Study location

Study Summary

This study will examine the effects of a single dose of psilocybin, administered with psychological support, on symptoms of depression. It will also assess whether different post-dosing interventions, including a non-invasive technique called transcutaneous auricular Vagus Nerve Stimulation (taVNS), influence various psychological and behavioral outcomes. In addition, the study will explore objective measures of real-world social behavior and identify early behavioral responses that may be associated with long-term treatment outcomes.

Primary Outcome

The MADRS is a 10-item depression rating scale that includes questions on the following symptoms: 1. Reported sadness, 2. Apparent sadness, 3. Inner tension, 4. Reduced sleep, 5. Reduced appetite, 6. Concentration difficulties, 7. Lassitude, 8. Inability to feel, 9. Pessimistic thoughts, and 10. Suicidal thoughts. Items are scored via a blinded clinical interview and rated to capture the patient's clinical state over the prior week. Each item yields a score of 0 to 6, and higher scores indicate

Conditions Studied

Interventions

  • DRUG Psilocybin
  • DEVICE Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
  • DEVICE Sham taVNS

Study Locations (1)

Colorado

  • Vail Health Behavioral Health - Edwards

Trial Details

FieldValue
Enrollment Target 141 participants
Start Date 2025-05-13
Est. Completion 2029-05
Phase Phase 2
Charles Raison

1 total trials

What NCT06512194 shows while recruiting

NCT06512194 is an interventional study that assigns participants to a tested intervention. The registered 141 participants enrollment target is mid-sized for trials with a published cap, below the 786-participant average among 679 other Depression trials with a reported enrollment target (82% lower).

The record links to 1 condition, with Depression appearing as the primary indexed condition, and to 3 interventions - of which Psilocybin is the first listed.

NCT06512194 reports a single indexed study location in Colorado.

Frequently Asked Questions

What is clinical trial NCT06512194 about?

NCT06512194 is a clinical study titled "Investigation to Understand and Optimize Psilocybin". This study will examine the effects of a single dose of psilocybin, administered with psychological support, on symptoms of depression. It will also assess whether different post-dosing interventions, including a non-invasive technique called transcutaneous auricular Vagus Nerve Stimulation (taVNS),...

What is the current status of trial NCT06512194?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 141 participants. The study started on 2025-05-13. Estimated completion is 2029-05.

What conditions does trial NCT06512194 study?

This clinical trial studies the following conditions: Depression.

What interventions are being tested in trial NCT06512194?

The interventions under investigation include: Psilocybin (DRUG), Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) (DEVICE), Sham taVNS (DEVICE).

Who is sponsoring clinical trial NCT06512194?

This trial is sponsored by Charles Raison, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06512194 being conducted?

This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Depression

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 NCT06512194's enrollment target sits among peer trials

141 270th of 679 higher than 409 of 679 other Depression trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Depression 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT03042962 · 141 participants

    Brain Networks in Dystonia

  • NCT04378439 · 141 participants · NA

    Appalachian Partnership to Reduce Disparities (Aim 2)

  • NCT04775485 · 141 participants · Phase 2

    A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors

  • NCT05040360 · 141 participants · Phase 2

    Testing the Use of Chemotherapy After Surgery for High-Risk Pancreatic Neuroendocrine Tumors

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT06358040 · started 2026-10 · NA

    Opioid Dispenser for Microdiscectomy/Laminectomy

Source: ClinicalTrials.gov NCT06512194, the US trial registry maintained by the National Library of Medicine. NCT06512194 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.