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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05948540 | Department of Defense PTSD Adaptive Platform Trial - Intervention C - Daridorexant | PHASE2 | RECRUITING | 200 | — | — | Nov 2, 2023 | Jul 1, 2029 | May 27, 2026 | 9 | United States |
A change in PTSD symptom severity from baseline as measured by CAPS-5-R Past Month. The range of the scale is 0-200. The higher the score at baseline, the worse the PTSD severity. The larger the decrease in score from baseline, the better the outcome.
The C-SSRS is an assessment of suicidal ideation and behavior in clinical and research settings. The C-SSRS consists of 16 questions that ask about suicidal ideation and behaviors (the first 10 questions comprise the ideation subscale and the last 6 comprise the behavior subscale). This 5-item subscale ranges from a minimum of 0 (corresponding to no suicidal ideation) to a maximum of 5 (representing active suicidal ideation with plan and intent).
| Arm | Type | Description |
|---|---|---|
| Intervention C Daridorexant | EXPERIMENTAL | - |
| Intervention C Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Intervention C Daridorexant | DRUG | Daridorexant will be administered 50 mg once daily at least 2 hours after the last meal and within 30 minutes of going to bed. |
| Intervention C Placebo | DRUG | A matching placebo will be administered at 50 mg daily in the same regimen as the intervention. |
Inclusion Criteria: No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT05422612). Exclusion Criteria: The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT05422612). 1. History of narcolep...