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CYB004 · 1 trial · 1 indication
The HAM-A is a 14-item scale that is used to rate the severity of symptoms of anxiety. Each of the 14 items is defined by a series of symptoms and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Items are scored from 0 (not present) to 4 (very severe), for a total score ranging from 0 to 56. Scores \<17 indicate mild anxiety, scores of 18 to 24 indicate mild to moderate anxiety, and scores of 25 to 30 or higher indicate moderate to severe anxiety.
| Arm | Type | Description |
|---|---|---|
| Arm A: Active | EXPERIMENTAL | Arm A participants will receive a full dose of CYB004 in 2 of 2 medicine sessions, approximately three weeks apart. All participants will receive supportive EMBARK psychotherapy throughout the study. |
| Arm B: Control | ACTIVE_COMPARATOR | Arm B participants will receive a low dose of CYB004 in 2 of 2 medicine sessions, approximately three weeks apart. All participants will receive supportive EMBARK psychotherapy throughout the study. |
| Name | Type | Description |
|---|---|---|
| CYB004 | DRUG | CYB004 is a synthetic deuterated N, N-Dimethyltryptamine (DMT) analog. |
| Psychotherapy | BEHAVIORAL | Manualized psychotherapy (called EMBARK) performed by facilitators |
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...
CYB004 is an investigational small molecule being developed for the treatment of Generalized Anxiety Disorder (GAD). It is a N,N-dimethyltryptamine (DMT) analog and is currently in Phase 2 clinical development. The drug is being studied in adults aged 18 years and older with GAD.
CYB004 is a N,N-dimethyltryptamine (DMT) analog. DMT is a psychedelic compound that acts on serotonin receptors, particularly the 5-HT2A receptor, which is thought to mediate its therapeutic effects in anxiety disorders. However, the specific molecular target of CYB004 has not been disclosed.
CYB004 is being developed by Cybin Inc., a biopharmaceutical company focused on psychedelic-based therapeutics. Cybin Inc. is publicly traded under the ticker symbol HELP. The company is conducting clinical trials to evaluate CYB004 for the treatment of Generalized Anxiety Disorder.
CYB004 is in Phase 2 clinical development. A Phase 2 study of CYB004 in participants with Generalized Anxiety Disorder has been completed. The drug is investigational and has not been approved by regulatory authorities. Further clinical development may be required to establish its safety and efficacy.
CYB004 has been studied in one clinical trial, identified as NCT06051721. This was a Phase 2, randomized, double-blind, active-controlled study in participants with Generalized Anxiety Disorder. The trial enrolled 36 participants in the United States and has been completed. No active trials are currently listed.
CYB004 is a N,N-dimethyltryptamine (DMT) analog, meaning it is a chemical derivative of DMT. While it is related to DMT, it is a distinct compound being developed by Cybin Inc. for Generalized Anxiety Disorder. The drug is currently in Phase 2 clinical trials and is not the same as DMT itself.