Approval Probability
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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...