MedTrace Logo

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

NCT06051721 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-10-27

No results posted yet for this 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.

Conditions

  • Generalized Anxiety Disorder

Interventions

DRUG

CYB004

CYB004 is a synthetic deuterated N, N-Dimethyltryptamine (DMT) analog.

BEHAVIORAL

Psychotherapy

Manualized psychotherapy (called EMBARK) performed by facilitators

Sponsors & Collaborators

  • Worldwide Clinical Trials

    collaborator OTHER

  • Cybin IRL Limited

    lead INDUSTRY

Principal Investigators

  • Amir Inamdar, MBBS, DNB, MFPM · Cybin IRL Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-10
Primary Completion
2025-10-14
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06051721 on ClinicalTrials.gov