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

This double-blind, active-controlled study (n=36) aims to evaluate the preliminary clinical efficacy, safety, tolerability, and pharmacokinetics of CYB004 (DMT) in participants diagnosed with Generalized Anxiety Disorder (GAD) with depressive symptoms.

Sponsored by Cybin IRL Limited, the study will commence in May 2024 and is estimated to be completed by February 2025. Participants aged 21 to 65 with moderate to severe GAD and co-occurring symptoms of depression will be included. They must have a BMI of 18 to 37.5 kg/m² and weigh at least 60 kg. Participants will undergo psychotherapy alongside the medication.

The study involves two arms: Arm A, which receives a full dose of CYB004, and Arm B, which receives a low dose of CYB004. The primary outcome measure is the Hamilton Anxiety Rating Scale (HAM-A), and the secondary outcome measure is the Hamilton Depression Scale (HAM-D).

The study design is a randomised, double-blind, active-controlled intervention with parallel assignment. The study will be conducted at locations in Georgia, United States.

Topic Anxiety
Compound DMT
Country United States of America
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 May 2024
End date 28 February 2025
Phase Phase I Phase II
Design Blinded
Type Interventional
Generation Second
Participants 36
Sex All
Age 18- 65
Therapy Yes

Trial Details

The purpose of this proof-of-concept study is to determine the safety, tolerability, and preliminary clinical efficacy of CYB004 participants with GAD with depressive symptoms.

NCT Number NCT06051721

Sponsors & Collaborators

Cybin
Cybin is a for-profit company that aims to deliver psychedelics (psilocybin) via a sublingual delivery mechanism. The company aims to start clinical trials within the year (2021). It has raised $98 million US.

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.