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NCT06793397 · ClinicalTrials.gov registry record · Phase 3

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

A Phase 3 study of Depression and Major Depressive Disorder (MDD), sponsored by Cybin IRL Limited.

Recruiting
Registry status
Phase 3
Development phase
330
Enrollment target
20
Study locations

NCT06793397 is a Phase 3 study of Depression and Major Depressive Disorder (MDD) that is actively recruiting participants, run by Cybin IRL Limited. The registered enrollment target is 330 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (58% lower). The trial reports 20 study locations across 10 states.

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The verdict

NCT06793397, a Phase 3 study of Depression and Major Depressive Disorder (MDD), is actively recruiting participants, sponsored by Cybin IRL Limited.

RECRUITING
Registry status
Phase 3
Development phase
330 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD.

Interventions

  • DRUG CYB003
  • BEHAVIORAL Psychological Support

Study Locations (20)

California

  • Behavioral Research Specialists, LLC - Glendale
  • Sun Valley Research Center - Imperial
  • CalNeuro Research Group - Los Angeles
  • ATP Clinical Research - Orange
  • NRC Research Institute - Orange
  • Inland Psychiatric Medical Group Inc (IPMG Research) - San Juan Capistrano
  • Psychedelic Science Institute - Santa Monica
  • Stanford University - Stanford

Florida

  • CNS Healthcare - Jacksonville
  • Accel Research Sites - Maitland - Maitland
  • Aqualane Clinical Research - Naples

Georgia

  • Emory University Dept of Psychiatry and Behavioral Studies - Atlanta
  • Psych Atlanta - Marietta

Alabama

  • UAB Psychiatry and Behavioral Neurology - Birmingham

Arizona

  • Lighthouse Psychiatry - Gilbert

Arkansas

  • Pillar Clinical Research - Little Rock - Little Rock

Connecticut

  • Yale School of Medicine - Yale Program for Psychedelic Science - New Haven

Illinois

  • Rush University - Chicago

Trial Details

FieldValue
Enrollment Target 330 participants
Start Date 2025-12-10
Est. Completion 2027-05-08
Phase Phase 3

Sponsor

Cybin IRL Limited

4 total trials

What the Registry Record Tells You About NCT06793397

The ClinicalTrials.gov registry entry for NCT06793397 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 330 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (58% lower). The listed sponsor is Cybin IRL Limited, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 6 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which CYB003 is the first listed.

NCT06793397 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT06793397 about?

NCT06793397 is a clinical study titled "A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder". The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD.

What is the current status of trial NCT06793397?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 330 participants. The study started on 2025-12-10. Estimated completion is 2027-05-08.

What conditions does trial NCT06793397 study?

This clinical trial studies the following conditions: Depression, Major Depressive Disorder (MDD), Depression - Major Depressive Disorder, Depression Disorders, Depression in Adults.

What interventions are being tested in trial NCT06793397?

The interventions under investigation include: CYB003 (DRUG), Psychological Support (BEHAVIORAL).

Who is sponsoring clinical trial NCT06793397?

This trial is sponsored by Cybin IRL Limited, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06793397 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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