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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05422612 | Department of Defense PTSD Adaptive Platform Trial - Master Protocol | PHASE2 | RECRUITING | 800 | — | — | Nov 2, 2023 | Sep 1, 2026 | Sep 8, 2025 | 10 | 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 A: Fluoxetine HCl | EXPERIMENTAL | - |
| Intervention A Placebo | PLACEBO_COMPARATOR | - |
| Intervention B Vilazodone | EXPERIMENTAL | - |
| Intervention B Placebo | PLACEBO_COMPARATOR | - |
| Intervention C Daridorexant | EXPERIMENTAL | - |
| Intervention C Placebo | PLACEBO_COMPARATOR | - |
| Intervention D SLS-002 | EXPERIMENTAL | - |
| Intervention D Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Intervention A Fluoxetine Hydrochloride (HCl) | DRUG | Fluoxetine will be administered at 10 to 60 mg daily. The initial dose for all participants will be 10 mg daily for 1 week, then increased to 20 mg daily for 2 weeks, then increased to 40 mg daily for 2 weeks, then increased to 60 mg daily for the remainder of the trial. One reduction in dose due to tolerability will be allowed. When a participant's dose is decreased due to tolerability, the dose will not be increased. |
| Intervention A Placebo | DRUG | A matching placebo will be administered at 10 to 60 mg daily in the same regimen as the intervention. |
| Intervention B Vilazodone Hydrochloride (HCl) | DRUG | Vilazodone HCl will be administered at 10 mg once daily for 7 days, followed by 20 mg for 7 days, followed by 40 mg for the remainder of the trial. There must be a minimum of 7 days between dosage increases. One reduction in dose due to tolerability will be allowed. After Week 8, dose reduction for tolerability is allowed, but dose increase is not allowed. |
| Intervention B Placebo | DRUG | A matching placebo will be administered at 10 to 40 mg daily in the same regimen as the intervention. |
| Intervention C Daridorexant | DRUG | Daridorexant will be administered 50 mg once daily. |
| Intervention C Placebo | DRUG | A matching placebo will be administered at 50 mg daily in the same regimen as the intervention. |
| Intervention D SLS-002 | DRUG | • SLS-002 will be administered via intranasal administration (one spray per nostril, per device) at 78 mg two times per week for the first eight weeks and then once a week for the last four weeks. |
| Intervention D Placebo | DRUG | A matching placebo will be administered via intranasal administration (one spray per nostril, per device) two times per week for the first eight weeks and then once a week for the last four weeks. |
Inclusion Criteria: A participant must meet all the following criteria to be eligible to participate in this study: 1. Is willing and able to provide written informed consent. 2. ≥18 and \<65 years of age at Screening. 3. Meets Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DS...