Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06051721 | A Study of a N, N-dimethyltryptamine (DMT) Analog (CYB004) in Participants With Generalized Anxiety Disorder (GAD) | PHASE2 | ACTIVE NOT_RECRUITING | 36 | — | — | May 10, 2024 | Sep 1, 2026 | Oct 27, 2025 | 6 | United States |
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...