Post Traumatic Stress DisorderPhase 2NCT05178316
A Study of JZP150 in Adults With Posttraumatic Stress Disorder
A Phase 2 study testing JZP150 in people with Post Traumatic Stress Disorder, run by Jazz Pharmaceuticals at 52 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- JZP150
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 282 participants
- Where
- 52 sitesUnited States
- Study dates
- 29 Dec 2021to 5 Dec 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Acute or unstable medical condition, behavioral or psychiatric disorder (other than PTSD)
- Suicidal behavior in the past 2 years or active suicidal ideation in the past 6 months
- Ongoing traumatic event or exposure to a traumatic event <3 months prior to Screening
- Index event > 12 years
- Index event is combat trauma
Trial locations and contacts
52 sites in 1 country.
52 sites in 1 country
United States52 sites
Advanced Discovery Research
Atlanta, Georgia, 30318
Dell Medical School Universityof Texas at Austin
Austin, Texas, 78712
Austin Clinical Trial Partners
Austin, Texas, 78737
Houston Clinical Trials
Bellaire, Texas, 77401
Clinical Innovations Inc.
Bellflower, California, 90706
Southern California Research, LLC
Beverly Hills, California, 90210
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Boston Clinical Trial
Boston, Massachusetts, 02131
SPRI Clinical Trials
Brooklyn, New York, 11235
Sanro Clinical Research Group, LLC
Bryant, Arkansas, 72022
American Medical Research, Inc
Chicago, Illinois, 60612
MCB Clinical Research Center
Colorado Springs, Colorado, 80910
CT Clinical Research
Cromwell, Connecticut, 06416
Relaro Medical Trials, LLC
Dallas, Texas, 75243
Midwest Clinical Research Center
Dayton, Ohio, 45417
CenExel iResearch
Decatur, Georgia, 30030
Eastside Therapeutic Resource
Everett, Washington, 98201
Northpointe Psychiatry
Flower Mound, Texas, 75028
Sarkis Clinical Trials
Gainesville, Florida, 32607
Behavioral Research Specialists, LLC
Glendale, California, 91206
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256
Accel Research Sites -Lakeland Clinical Research Unit
Lakeland, Florida, 33803
Accel Research Sites Network-St. Petersburg Clinical Research Unit
Largo, Florida, 33777
Altea Research Institute
Las Vegas, Nevada, 89102
Alivation Research, LLC
Lincoln, Nebraska, 68526
Manhattan Behavioral Medicine
Manhattan, New York, 10036
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119
Premier Clinical Research Institute
Miami, Florida, 33122
EZY Medical Research Co
Miami, Florida, 33175
Behavioral Clinical Research, Inc
Miami Lakes, Florida, 33016
North Star Medical Research, LLC
Middleburg Heights, Ohio, 44130
Yale Center for Clinical Investigation: Church Street Research Unit (CSRU)
New Haven, Connecticut, 06519
Neuro-Behavioral Clinical Research, Inc
North Canton, Ohio, 44720
Excell Research
Oceanside, California, 92056
IPS Research Company
Oklahoma City, Oklahoma, 73106
Paradigm Research Professionals, LLC
Oklahoma City, Oklahoma, 73118
NRC Research Institute
Orange, California, 92868
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801
NoesisPharma LLC
Phoenix, Arizona, 85016
Global Medical Institutes, LLC: Princeton Medical Institute
Princeton, New Jersey, 08540
Pillar Clinical Research, LLC
Richardson, Texas, 75080
CITrials
Riverside, California, 92506
Finger Lakes Clinical Research
Rochester, New York, 14618
Woodland Research Northwest
Rogers, Arkansas, 72758
Clinical Trials of Texas
San Antonio, Texas, 78229
Clinical Innovations Inc.
Santa Ana, California, 90705
Richmond Behavioral Associates
Staten Island, New York, 10314
Collaborative Neuroscience Research, LLC
Torrance, California, 90504
Pacific Clinical Research Management Group LLC
Upland, California, 91786
Howard University Hospital, Clinical Research Unit
Washington D.C., District of Columbia, 20060
Suburban Research Associates
West Chester, Pennsylvania, 19380
Grayline Research Center
Wichita Falls, Texas, 76309
About this study
Official title: A Multicenter Phase 2, 12-week Double-blind, Placebo-controlled, Randomized, Parallel-group Study of JZP150 for the Treatment of Posttraumatic Stress Disorder
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).
Read the 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).
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- JZP150, Placebo
- Keywords
- Post Traumatic Stress Disorder, JZP150
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JZP150Drug
Oral administration of JZP150 once daily in the morning
PlaceboDrug
Oral administration of placebo once daily in the morning
| Study group | Role | What they receive |
|---|---|---|
| JZP150 0.3 mg | Experimental | Participants who will be randomized to receive JZP150 0.3 mg orally once daily for up to 12 weeks. Receives: Drug: JZP150 |
| JZP150 4.0 mg | Experimental | Participants who will be randomized to receive JZP150 4.0 mg orally once daily for up to 12 weeks. Receives: Drug: JZP150 |
| Placebo | Placebo comparator | Participants who will be randomized to receive placebo orally once daily for up to 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline to Week 12 in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS-5) Total Symptom Severity Score
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.
Measured: Baseline to Week 12
Secondary outcomes (2)
Mean Change From Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S)
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".
Change in CGI-S is being reported with negative mean values indicating an improvement in clinical outcome.
Measured: Baseline to Week 12
Mean Change From Baseline to Week 12 in Patient Global Impression of Severity (PGI-S)
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".
Change in PGI-S is being reported with negative mean values indicating an improvement in clinical outcome.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start29 Dec 2021
- Primary completion5 Dec 2023
- Study completion5 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05178316
- Sponsor's protocol ID
- JZP150-201
- Status last verified
- Dec 2024
- First submitted
- 8 Dec 2021
- Last updated
- 31 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with ICMJE requirements, Jazz Pharmaceuticals may provide qualified external researchers access to individual participant data (IPD) and clinical trial data that underlie the results of this trial upon request. Qualified researchers can submit a request on https://www.jazzpharma.com/science/clinical-trial-data-sharing/ as outlined. Jazz Pharmaceuticals reserves the right not to consider a request. For inquiries about Jazz's data sharing policy contact clinicaldatasharing@jazzpharma.com.
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase 2, 12-week Double-blind, Placebo-controlled, Randomized, Parallel-group Study of JZP150 for the Treatment of Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT05178316
- Acronym / sponsor ID
- JZP150-201
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- Post Traumatic Stress Disorder, JZP150
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 29 Dec 2021 (actual)
- Primary completion
- 5 Dec 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 5 Jan 2022 (actual)
- Results
- Posted 31 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| JZP150 0.3 mg | Experimental | Drug: JZP150Participants who will be randomized to receive JZP150 0.3 mg orally once daily for up to 12 weeks. |
| JZP150 4.0 mg | Experimental | Drug: JZP150Participants who will be randomized to receive JZP150 4.0 mg orally once daily for up to 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants who will be randomized to receive placebo orally once daily for up to 12 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Acute or unstable medical condition, behavioral or psychiatric disorder (other than PTSD)
- Suicidal behavior in the past 2 years or active suicidal ideation in the past 6 months
- Ongoing traumatic event or exposure to a traumatic event <3 months prior to Screening
- Index event > 12 years
- Index event is combat trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JZP150Oral administration of JZP150 once daily in the morning | Drug | JZP150 0.3 mg, JZP150 4.0 mg |
| PlaceboOral administration of placebo once daily in the morning | Drug | Placebo |
Primary outcome
Mean Change From Baseline to Week 12 in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS-5) Total Symptom Severity Score
Time frame: 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. 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.
2 secondary outcomes
Mean Change From Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S)
Time frame: Baseline to Week 12
Mean Change From Baseline to Week 12 in Patient Global Impression of Severity (PGI-S)
Time frame: Baseline to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. In accordance with ICMJE requirements, Jazz Pharmaceuticals may provide qualified external researchers access to individual participant data (IPD) and clinical trial data that underlie the results of this trial upon request. Qualified researchers can submit a request on https://www.jazzpharma.com/science/clinical-trial-data-sharing/ as outlined. Jazz Pharmaceuticals reserves the right not to consider a request. For inquiries about Jazz's data sharing policy contact clinicaldatasharing@jazzpharma.com.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
52 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JZP150 in people with Post Traumatic Stress Disorder, run by Jazz Pharmaceuticals at 52 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline to Week 12 in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS-5) Total Symptom Severity Score (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.