Clinical trial NCT06051721: A Study of a N, N-dimethyltryptamine (DMT) Analog (CYB004) in Participants with Generalized Anxiety Disorder (GAD)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Generalized Anxiety Disorder
Keywords: Generalized Anxiety Disorder
GAD
Depression
CYB004
CYB004-002
Psychedelic
DMT
N, N-dimethyltryptamine
Lead sponsor: Cybin IRL Limited
Sponsor class: INDUSTRY
Collaborators: name: Worldwide Clinical Trials
First posted: 2023-09-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: 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)
Secondary outcomes:
measure: Hamilton Depression Scale (HAM-D)
timeFrame: 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)
Other outcomes:
Locations:
city: Miami Lakes
country: United States
facility: Innovative Clinical Research, Inc.
state: Florida
city: Atlanta
country: United States
facility: CenExel ACMR
state: Georgia
city: Decatur
country: United States
facility: iResearch Atlanta
state: Georgia
city: Murray
country: United States
facility: Cedar Clinical Research
state: Utah
Study officials:
affiliation: Cybin IRL Limited
name: Amir Inamdar, MBBS, DNB, MFPM
role: STUDY_DIRECTOR
References: