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JZP150 · 1 trial · 1 indication
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...
JZP150 is an investigational small molecule being developed for the treatment of Post Traumatic Stress Disorder (PTSD). It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
JZP150 is being developed by Jazz Pharmaceuticals plc, a biopharmaceutical company traded on the NASDAQ under the ticker symbol JAZZ.
JZP150 is in Phase 2 clinical development. It is an investigational drug and has not yet been approved for any use. A Phase 2 study in adults with PTSD has been completed.
JZP150 has one completed Phase 2 clinical trial, NCT05178316, titled 'A Study of JZP150 in Adults With Posttraumatic Stress Disorder.' This randomized, double-blind, placebo-controlled study enrolled 282 participants in the United States.
JZP150 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Post Traumatic Stress Disorder. Its safety and efficacy have not been established.