CYB004 / Psychotherapy / Generalized Anxiety Disorder · Phase 2 Trial

A Study of a N, N-dimethyltryptamine (DMT) Analog (CYB004) in Participants With Generalized Anxiety Disorder (GAD)

ClinicalTrials.gov · August 13, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 2 proof-of-concept trial of CYB004 (a DMT analog) combined with psychotherapy in 36 participants with generalized anxiety disorder. The registry record confirms enrollment completion and lists the primary outcome measure (HAM-A at multiple timepoints) but does not report any efficacy, safety, or tolerability results.

What was studied

Phase 2, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Generalized Anxiety Disorder; age from 18 Years; to 65 Years. Intervention: Arm A: Active. Compared with: Arm B: Control — Active Comparator. n = 36. 6 sites: United States.

Key findings

Safety

Results are not posted in this registry record; no efficacy, safety, or tolerability data are available.

Who this may help

No clinical impact can be assessed from this registry record, as no results are reported. Clinicians should await publication of efficacy and safety data before considering this agent.

Plain-language summary

This is a Phase 2 proof-of-concept trial with completed enrollment but no results posted in this registry record; early-phase design and stated purpose to examine safety and preliminary efficacy support preliminary classification.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Hamilton Anxiety Rating Scale (HAM-A) (assessed at Screening (Day-63 and Day-1), Day 2, Day 8, Day 21, Day 23, Day 29, Day 43, Day…)

DesignPhase 2, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose

PopulationGeneralized Anxiety Disorder; age from 18 Years; to 65 Years

Sample size36

InterventionArm A: Active

ComparatorArm B: Control — Active Comparator

Setting6 sites: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment36

PhasePhase 2

Primary outcome measureHamilton Anxiety Rating Scale (HAM-A)

Assessment timepointsDay-63, Day-1, Day 2, Day 8, Day 21, Day 23, Day 29, Day 43, Day 64, Day 85, Day 169, Day 266, Day 364

Clinical bottom line

No clinical impact can be assessed from this registry record, as no results are reported. Clinicians should await publication of efficacy and safety data before considering this agent.

Caveats

Results are not posted in this registry record; no efficacy, safety, or tolerability data are available.
Blinding, randomization method, and control arm details are not described in the registry entry.
No comparator group or control condition is specified.
Long-term follow-up extends to Day 364, but interim or final outcome data are not reported.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 2 interventional study with drug and behavioral components; design details limited in registry.

Directness

strong

Directly addresses GAD with clinical outcome measure (HAM-A) in target population.

Consistency

insufficient

Single study; no comparator data or prior results reported in this record.

Risk of bias

insufficient

Registry record does not describe blinding, randomization, or allocation concealment.

Sample adequacy

limited

36 participants enrolled; typical Phase 2 size but modest for definitive efficacy claim.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06051721). This is a study registration, not published results. Lead sponsor: Cybin IRL Limited. Recruitment status: COMPLETED. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 36 participants (ACTUAL). Conditions: Generalized Anxiety Disorder. Interventions: DRUG: CYB004; BEHAVIORAL: Psychotherapy. Primary outcome measures: Hamilton Anxiety Rating Scale (HAM-A) , Screening (Day-63 and Day-1), Day 2, Day 8, Day 21, Day 23, Day 29, Day 43, Day 64, Day 85, Day 169, Day 266, and End of Treatment (Day 364). Brief 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT06051721Cybin IRLCYB004PsychotherapyGeneralized Anxiety Disorder