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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05178316 | A Study of JZP150 in Adults With Posttraumatic Stress Disorder | PHASE2 | COMPLETED | 282 | — | — | Dec 29, 2021 | Dec 5, 2023 | Dec 31, 2024 | 52 | United States |
Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS-5) is a clinician administered, clinical interview where participants report on their symptoms of PTSD on a scale. The CAPS-5 total score ranges between 0 and 80. Higher scores indicate more severe PTSD symptoms. Change in CAPS-5 total score is being reported, where negative mean scores indicate an improvement in clinical outcome.
| Arm | Type | Description |
|---|---|---|
| JZP150 0.3 mg | EXPERIMENTAL | Participants who will be randomized to receive JZP150 0.3 mg orally once daily for up to 12 weeks. |
| JZP150 4.0 mg | EXPERIMENTAL | Participants who will be randomized to receive JZP150 4.0 mg orally once daily for up to 12 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants who will be randomized to receive placebo orally once daily for up to 12 weeks. |
| Name | Type | Description |
|---|---|---|
| JZP150 | DRUG | Oral administration of JZP150 once daily in the morning |
| Placebo | DRUG | Oral administration of placebo once daily in the morning |
Inclusion Criteria: * Participants aged 18 to 70 years * Participants must be outpatients with a primary diagnosis of Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) defined PTSD confirmed by the clinical interview * PTSD is primary diagnosis Exclusion Criteria: * Acute...