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JZP150 for Post-Traumatic Stress Disorder
Phase 2
Waitlist Available
Research Sponsored by Jazz Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Many of those who suffer from PTSD use cannabis. If you use cannabis, are you willing to refrain from cannabis use during the duration of the study (approximately 18 weeks)?
Did you experience a traumatic event within the last 9 years?
Must not have
Is your PTSD due to war combat?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 12
Summary
This trial tests a pill called JZP150 on adults with PTSD to see if it can reduce their symptoms. JZP150 blocks an enzyme to help increase brain chemicals that improve mood and reduce stress.
Eligible Conditions
- Post Traumatic Stress Disorder
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowExclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean Change from Baseline to Week 12 in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS-5) Total Symptom Severity Score
Secondary study objectives
Mean Change from Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S)
Mean Change from Baseline to Week 12 in Patient Global Impression of Severity (PGI-S)
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: JZP150 4.0 mgExperimental Treatment1 Intervention
Participants who will be randomized to receive JZP150 4.0 mg orally once daily for up to 12 weeks.
Group II: JZP150 0.3 mgExperimental Treatment1 Intervention
Participants who will be randomized to receive JZP150 0.3 mg orally once daily for up to 12 weeks.
Group III: PlaceboPlacebo Group1 Intervention
Participants who will be randomized to receive placebo orally once daily for up to 12 weeks.
Find a Location
Who is running the clinical trial?
Jazz PharmaceuticalsLead Sponsor
251 Previous Clinical Trials
34,764 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- About how many years ago did the traumatic event occur that led to your PTSD diagnosis? If you have experienced more than 1 traumatic event, how long ago was the worst event?
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: JZP150 0.3 mg
- Group 3: JZP150 4.0 mg
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT05178316 — Phase 2