Testing a new DMT analog for treating generalized anxiety disorder

A Phase 2a, Randomized, Double-Blind, Active-Controlled Study to Assess the Preliminary Clinical Efficacy, Safety, Tolerability, and Pharmacokinetics, of CYB004 in Participants with Generalized Anxiety Disorder (GAD)

This study is testing a new treatment called CYB004, a DMT analog, to see if it can help people aged 18 to 65 with generalized anxiety disorder feel better when combined with therapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Cybin IRL Limited (Industry-sponsored)
• Locations: 4 sites (Miami Lakes, Florida and 3 other locations)
• Trial ID: NCT06051721 on ClinicalTrials.gov

What this trial studies

This proof-of-concept trial aims to evaluate the safety, tolerability, pharmacokinetics, and preliminary clinical efficacy of CYB004, a DMT analog, in participants diagnosed with generalized anxiety disorder (GAD). Participants aged 18 to 65 with moderate to severe GAD will receive CYB004 alongside psychotherapy. The study will monitor their response to the treatment and assess any side effects. The trial is designed to provide insights into the potential therapeutic effects of this novel compound on anxiety symptoms.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with a diagnosis of moderate to severe generalized anxiety disorder who have not adequately responded to standard treatments.

Not a fit: Patients with primary psychiatric diagnoses other than generalized anxiety disorder or those who have not had an inadequate response to previous treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients suffering from generalized anxiety disorder.

How similar studies have performed: While the use of DMT analogs in treating anxiety is a novel approach, preliminary studies on psychedelics for mental health conditions have shown promising results.

Eligibility criteria

Inclusion Criteria:

* Aged between 18 to 65 years, inclusive, at Screening.
* Has a diagnosis of GAD (as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition \[DSM-V\] of moderate to severe degree), established through a full psychiatric work up.
* Has a BMI of 18 to 40.0 kg/m2, inclusive at Screening.
* Has been on a stable dose of antidepressant/anxiolytic medication (no more than 50% change) in the last month prior to Screening and has had an inadequate response, as judged by the Investigator.
* Is willing to refrain from taking any benzodiazepines for 5 days or buspirone (or other 5- HT1A agonist) during the 24 hours preceding each dosing visit.
* Provision of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Exclusion Criteria:

* Has a primary DSM-5 psychiatric diagnosis other than GAD within the past 6 months established through a full psychiatric work-up. A secondary diagnosis of MDD may be permissible.
* Current or previously diagnosed schizophrenia spectrum or other psychotic disorders, including schizophrenia, schizoaffective disorder, schizotypal disorder, schizophreniform disorder, brief psychotic disorder or borderline personality disorder; current or previous history of psychosis or bipolar disorder.
* Currently taking a monoamine oxidase inhibitor, tricyclic antidepressant, trazadone, mirtazapine, or a mood stabilizer (including lithium) or has taken any of these medications in the last 3 weeks of trial participation.
* Currently taking antipsychotic medication which are 5-HT2 antagonists or has taken such medication in the last 3 weeks of trial participation.
* Clinically significant risk of suicidality, as determined through a comprehensive psychiatric interview.
* Clinically relevant history of abnormal physical health interfering with the study as determined by medical history and physical examinations obtained during Screening as judged by the Investigator (including \[but not limited to\], neurological, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder).
* Currently receiving treatment for hypertension or arrhythmia.
* Clinically relevant abnormal laboratory results.
* History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study drug.
* Any other concomitant disease or condition that could interfere with, or for which the treatment might interfere with the conduct of the trial, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this trial.
* Has a presence or relevant history of any organic brain disorders (e.g., epilepsy, seizure, intracranial hypertension, intracranial bleed and aneurysmal disease, brain tumor or other medical conditions associated with seizures or convulsions).
* Consumes excessive amounts of caffeine (e.g., coffee, tea, caffeinated sodas) or (methyl) xanthines (e.g., chocolate) based on the Investigator's determination and discretion.
* Positive urine test for drugs of abuse or alcohol breath test at Screening or Day 1. A positive test for cannabinoids (e.g. marijuana) at Screening may not exclude a participant if after discussion with and evaluation by the Investigator, the participant agrees not to use any marijuana or other cannabinoid products during the study, and if allowed to participate, the participant must test negative for cannabinoids on Day 1 and Day 22.
* Has participated in a clinical trial and has received a medication or a new chemical entity within 3 months prior to dosing of current study medication.
* Known sensitivity to DMT or ayahuasca.
* Is taking a prescription medicine (except for stable chronic dose of antidepressant/anxiolytic medication(s), sedatives/hypnotics, and hormonal contraceptives or hormonal replacement medications, if applicable), certain herbal supplements (to be reviewed by the Investigator), or over-the-counter (OTC) medicine during the 28 days before dosing.
* Is taking or has taken over the counter (OTC) doses of 5-hydroxytryptophan or St John's Wort within 28 days prior to receiving the study drug.
* Donation of blood or plasma of \>400 mL within 1 month prior to first dosing until 4 weeks after final dosing.
* For participants capable of producing sperm: Is not willing to abstain from sperm donation between first dosing and 3 months after final dosing.
* For participants capable: Is pregnant, breastfeeding or planning to conceive.
* Not fluent in the English language.
* Other eligibility considerations (i.e., participant personal circumstances, behavior, and/or any current problem that might interfere with participation or that is incompatible with establishment of rapport or safe exposure to the study drug), as judged by the Investigator.

Where this trial is running

Miami Lakes, Florida and 3 other locations

• Innovative Clinical Research, Inc. — Miami Lakes, Florida, United States (Recruiting)
• CenExel ACMR — Atlanta, Georgia, United States (Recruiting)
• iResearch Atlanta — Decatur, Georgia, United States (Recruiting)
• Cedar Clinical Research — Murray, Utah, United States (Recruiting)

Study contacts

• Study coordinator: Study Manager

Conditions Generalized Anxiety Disorder; GAD; Depression; CYB004; CYB004-002; Psychedelic; DMT; N, N-dimethyltryptamine