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NCT06051721 · ClinicalTrials.gov registry record · Phase 2
A Study of a N, N-dimethyltryptamine (DMT) Analog (CYB004) in Participants With Generalized Anxiety Disorder (GAD)
A Phase 2 study of Generalized Anxiety Disorder, sponsored by Cybin IRL Limited.
- Active
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 6
- Study locations
NCT06051721: Active Phase 2 study of Generalized Anxiety Disorder, sponsored by Cybin IRL Limited.
NCT06051721 is a Phase 2 study of Generalized Anxiety Disorder that is active but no longer recruiting, run by Cybin IRL Limited. The registered enrollment target is 36 participants, below the 214-participant average among 48 other Generalized Anxiety Disorder trials with a reported enrollment target (83% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06051721, a Phase 2 study of Generalized Anxiety Disorder, is active but no longer recruiting, sponsored by Cybin IRL Limited.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 6
- Study locations
Study Summary
The purpose of this proof-of-concept trial is to examine the safety, tolerability, and pharmacokinetics (PK), and preliminary clinical efficacy of CYB004 participants with GAD.
Primary Outcome
The HAM-A is a 14-item scale that is used to rate the severity of symptoms of anxiety. Each of the 14 items is defined by a series of symptoms and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Items are scored from 0 (not present) to 4 (very severe), for a total score ranging from 0 to 56. Scores \<17 indicate mild anxiety, scores of 18 to 24 indicate mild to moderate anxiety, and scores of 25 to 30 or hi
Conditions Studied
Interventions
- BEHAVIORAL Psychotherapy
- DRUG CYB004
Study Locations (6)
Florida
- Research Centers of America - Hollywood
- Innovative Clinical Research, Inc. - Miami Lakes
Georgia
- CenExel ACMR - Atlanta
- iResearch Atlanta - Decatur
Illinois
- Uptown Research Institute - Chicago
Utah
- Cedar Clinical Research - Murray
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2024-05-10 |
| Est. Completion | 2026-09 |
| Phase | Phase 2 |
What the registry record for NCT06051721 still lists
NCT06051721 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 214-participant average among 48 other Generalized Anxiety Disorder trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Generalized Anxiety Disorder appearing as the primary indexed condition, and to 2 interventions - of which Psychotherapy is the first listed.
NCT06051721 lists 6 locations in 4 states (Florida, Georgia, Illinois).
Frequently Asked Questions
What is clinical trial NCT06051721 about?
NCT06051721 is a clinical study titled "A Study of a N, N-dimethyltryptamine (DMT) Analog (CYB004) in Participants With Generalized Anxiety Disorder (GAD)". The purpose of this proof-of-concept trial is to examine the safety, tolerability, and pharmacokinetics (PK), and preliminary clinical efficacy of CYB004 participants with GAD.
What is the current status of trial NCT06051721?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2024-05-10. Estimated completion is 2026-09.
What conditions does trial NCT06051721 study?
This clinical trial studies the following conditions: Generalized Anxiety Disorder.
What interventions are being tested in trial NCT06051721?
The interventions under investigation include: Psychotherapy (BEHAVIORAL), CYB004 (DRUG).
Who is sponsoring clinical trial NCT06051721?
This trial is sponsored by Cybin IRL Limited, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06051721 being conducted?
This trial has 6 study locations across Florida, Georgia, Illinois, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06051721's enrollment target sits among peer trials
36 43rd of 48 higher than 5 of 48 other Generalized Anxiety Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Generalized Anxiety Disorder 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.
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