Post Traumatic Stress Disorder
Conditions
Keywords
Post Traumatic Stress Disorder, JZP150
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).
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).
Interventions
DRUGJZP150
Oral administration of JZP150 once daily in the morning
DRUGPlacebo
Oral administration of placebo once daily in the morning
Sponsors
Jazz Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. Change in CGI-S is being reported with negative mean values indicating an improvement in clinical outcome. |
| 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. Change in PGI-S is being reported with negative mean values indicating an improvement in clinical outcome. |
Countries
United States
Participant flow
Recruitment details
A total of 282 participants who met all inclusion criteria and no exclusion criteria were randomized to treatment. Of those 282 participants, 277 received at least 1 dose of study intervention. Five participants did not receive any treatment.
Participants by arm
| Arm | Count |
|---|---|
| JZP150 0.3 mg Participants who were randomized to JZP150 0.3 mg orally once daily for up to 12 weeks. | 54 |
| JZP150 4.0 mg Participants who were randomized to JZP150 4.0 mg orally once daily for up to 12 weeks. | 113 |
| Placebo Participants who were randomized to placebo orally once daily for up to 12 weeks. | 110 |
| Total | 277 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 5 | 4 | 9 |
| Overall Study | Enrolled in Error | 1 | 2 | 1 |
| Overall Study | Lost to Follow-up | 3 | 15 | 11 |
| Overall Study | Noncompliance | 1 | 3 | 1 |
| Overall Study | Other | 0 | 1 | 0 |
| Overall Study | Physician Decision | 0 | 3 | 2 |
| Overall Study | Protocol deviation | 1 | 0 | 1 |
| Overall Study | Sponsor decision | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 11 | 5 |
Baseline characteristics
| Characteristic | JZP150 0.3 mg | JZP150 4.0 mg | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 38.4 years STANDARD_DEVIATION 13.54 | 38.6 years STANDARD_DEVIATION 12.45 | 41.2 years STANDARD_DEVIATION 12.52 | 39.6 years STANDARD_DEVIATION 12.72 |
| Age, Customized ≤45 years | 37 Participants | 79 Participants | 72 Participants | 188 Participants |
| Age, Customized >45 years | 17 Participants | 34 Participants | 38 Participants | 89 Participants |
| Age, Customized ≤65 years | 53 Participants | 111 Participants | 106 Participants | 270 Participants |
| Age, Customized >65 years | 1 Participants | 2 Participants | 4 Participants | 7 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 3 Participants | 6 Participants | 12 Participants |
| Race/Ethnicity, Customized Black or African American | 12 Participants | 16 Participants | 15 Participants | 43 Participants |
| Race/Ethnicity, Customized Declined to state | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Multiple | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 38 Participants | 92 Participants | 85 Participants | 215 Participants |
| Sex: Female, Male Female | 44 Participants | 85 Participants | 81 Participants | 210 Participants |
| Sex: Female, Male Male | 10 Participants | 28 Participants | 29 Participants | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 54 | 0 / 113 | 0 / 110 |
| other Total, other adverse events | 20 / 54 | 30 / 113 | 24 / 110 |
| serious Total, serious adverse events | 1 / 54 | 2 / 113 | 1 / 110 |
Outcome results
Primary
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.
Time frame: Baseline to Week 12
Population: CAPS-5 total symptom severity score was assessed in participants with available data in the Full Analysis Set 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| JZP150 0.3 mg | Mean Change From Baseline to Week 12 in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS-5) Total Symptom Severity Score | -17.0 score on a scale | Standard Deviation 13.75 |
| JZP150 4.0 mg | Mean Change From Baseline to Week 12 in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS-5) Total Symptom Severity Score | -17.8 score on a scale | Standard Deviation 12.59 |
| Placebo | Mean Change From Baseline to Week 12 in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS-5) Total Symptom Severity Score | -17.6 score on a scale | Standard Deviation 11.99 |
p-value: =0.886295% CI: [-3.98, 4.6]Mixed Models Analysis
p-value: =0.683295% CI: [-4.32, 2.84]Mixed Models Analysis
Secondary
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.
Time frame: Baseline to Week 12
Population: CGI-S was assessed in participants with available data in the Full Analysis Set 1 (defined as
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| JZP150 0.3 mg | Mean Change From Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S) | -1.4 score on a scale | Standard Deviation 1.1 |
| JZP150 4.0 mg | Mean Change From Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S) | -1.3 score on a scale | Standard Deviation 1.27 |
| Placebo | Mean Change From Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S) | -1.2 score on a scale | Standard Deviation 1.08 |
p-value: =0.452295% CI: [-0.55, 0.25]Mixed Models Analysis
p-value: =0.203295% CI: [-0.55, 0.12]Mixed Models Analysis
Secondary
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.
Time frame: Baseline to Week 12
Population: PGI-S was assessed in participants with available data in the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| JZP150 0.3 mg | Mean Change From Baseline to Week 12 in Patient Global Impression of Severity (PGI-S) | -1.0 score on a scale | Standard Deviation 1.17 |
| JZP150 4.0 mg | Mean Change From Baseline to Week 12 in Patient Global Impression of Severity (PGI-S) | -1.1 score on a scale | Standard Deviation 1.11 |
| Placebo | Mean Change From Baseline to Week 12 in Patient Global Impression of Severity (PGI-S) | -1.0 score on a scale | Standard Deviation 1.09 |
p-value: =0.71795% CI: [-0.38, 0.26]Mixed Models Analysis
p-value: =0.242395% CI: [-0.43, 0.11]Mixed Models Analysis