A Study of JZP150 in Adults With Posttraumatic Stress Disorder
Study Details
Study Description
Brief Summary
This is a 12-week, double-blind, placebo-controlled, randomized, parallel-group, multicenter study of the safety and efficacy of JZP150 in the treatment of adult participants with post-traumatic stress disorder (PTSD).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
JZP150 is an oral, highly selective inhibitor of fatty acid amide hydrolase (FAAH). In this phase 2 study, participants with PTSD will receive either placebo or 1 of 2 doses of JZP150. The primary objective of the study will assess the change in PTSD symptoms from baseline to Week 12 using the Clinician Administered PTSD Scale (CAPS-5).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: JZP150 0.3 mg Participants who will be randomized to receive JZP150 0.3 mg orally once daily for up to 12 weeks. |
Drug: JZP150
Oral administration of JZP150 once daily in the morning
|
Experimental: JZP150 4.0 mg Participants who will be randomized to receive JZP150 4.0 mg orally once daily for up to 12 weeks. |
Drug: JZP150
Oral administration of JZP150 once daily in the morning
|
Placebo Comparator: Placebo Participants who will be randomized to receive placebo orally once daily for up to 12 weeks. |
Drug: Placebo
Oral administration of placebo once daily in the morning
|
Outcome Measures
Primary Outcome Measures
- Mean Change from Baseline to Week 12 in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS-5) Total Symptom Severity Score [Baseline to Week 12]
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 range from 0 to 5, where 0 indicates the symptoms are "absent" and 5 indicates the symptoms are "extreme/incapacitating".
Secondary Outcome Measures
- Mean Change from Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S) [Baseline to Week 12]
Clinical Global Impression of Severity (CGI-S) is a clinician assessment used to assess the severity of the participants' PTSD on a scale range of 1 to 7, where 1 indicates "normal, not at all ill" and a 7 indicates "among the most extremely ill participants".
- Mean Change from Baseline to Week 12 in Patient Global Impression of Severity (PGI-S) [Baseline to Week 12]
Patient Global Impression of Severity (PGI-S) is a patient assessment designed to evaluate severity of PTSD symptoms on a scale from 1 to 5, where 1 indicates "none" and 5 indicates "very severe".
Eligibility Criteria
Criteria
Inclusion Criteria:
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Participants aged 18 to 70 years
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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
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PTSD is primary diagnosis
Exclusion Criteria:
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Acute or unstable medical condition, behavioral or psychiatric disorder (other than PTSD)
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Suicidal behavior in the past 2 years or active suicidal ideation in the past 6 months
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Ongoing traumatic event or exposure to a traumatic event <3 months prior to Screening
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Index event > 12 years
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Index event is combat trauma
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Altea Research | Phoenix | Arizona | United States | 85012 |
2 | Clinical Innovations Inc. | Bellflower | California | United States | 90706 |
3 | Southern California Research, LLC | Beverly Hills | California | United States | 90210 |
4 | Behavioral Research Specialists, LLC | Glendale | California | United States | 91206 |
5 | Excell Research | Oceanside | California | United States | 92056 |
6 | CITrials | Riverside | California | United States | 92506 |
7 | Clinical Innovations Inc. | Santa Ana | California | United States | 90705 |
8 | Sarkis Clinical Trials | Gainesville | Florida | United States | 32607 |
9 | Behavioral Clinical Research, Inc | Miami Lakes | Florida | United States | 33016 |
10 | Premier Clinical Research Institute | Miami | Florida | United States | 33122 |
11 | EZY Medical Research Co | Miami | Florida | United States | 33175 |
12 | Boston Clinical Trial | Boston | Massachusetts | United States | 02131 |
13 | Alivation Research, LLC | Lincoln | Nebraska | United States | 68526 |
14 | Global Medical Institutes, LLC: Princeton Medical Institute | Princeton | New Jersey | United States | 08540 |
15 | Finger Lakes Clinical Research | Rochester | New York | United States | 14618 |
16 | Richmond Behavioral Associates | Staten Island | New York | United States | 10312 |
17 | Midwest Clinical Research Center | Dayton | Ohio | United States | 45417 |
18 | Neuro-Behavioral Clinical Research, Inc | North Canton | Ohio | United States | 44720 |
19 | Austin Clinical Trial Partners | Austin | Texas | United States | 78737 |
20 | Pillar Clinical Research, LLC | Richardson | Texas | United States | 75080 |
21 | Clinical Trials of Texas | San Antonio | Texas | United States | 78229 |
22 | Grayline Research Center | Wichita Falls | Texas | United States | 76309 |
Sponsors and Collaborators
- Jazz Pharmaceuticals
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- JZP150-201-01