Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2025-12-24 @ 8:02 PM
NCT ID:
NCT02277704
Eligibility Criteria:
Inclusion Criteria:
* Male or female between 18 and 65 years of age
* Diagnosed with current PTSD as defined by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5),
* For patients with a qualifying Index trauma(s) resulting in PTSD that occurred during military service, military contractor, Department of Homeland Security or law enforcement
* Willing and able to withdraw and refrain from specific therapies (ask PI)
* Use medically acceptable form of contraception (female only)
* Signed informed consent
Exclusion Criteria:
* Significant traumatic brain injury
* Severe depression
* Bipolar and psychotic disorders
* Increase risk of suicide
* Significant clinical (cardiac, systemic infection, drug/alcohol abuse) or laboratory abnormalities (including positivity for Hep B, Hep C, HIV)
* Unable to wash-out specific medications (ask PI)
* History of violent behavior within past 2 years, unrelated to work duties
* History of drug or alcohol abuse within past 6 months
* Positive illegal substance test
* Known hypersensitivity to cyclobenzaprine
* Others: seizure disorders, uncontrolled sleep apnea, BMI\>40
* Participation in an investigational study in past 30 days
* In the process of litigating for compensation for a psychiatric disorder
* Females that are pregnant or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02277704
Study Brief:
Protocol Section:
NCT02277704