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 @ 3:35 PM
Ignite Modification Date:
2025-12-24 @ 3:35 PM
NCT ID:
NCT02545192
Eligibility Criteria:
Inclusion Criteria:
1. Subjects will be men or women between the ages of 21-65.
2. Subjects will meet Diagnostics and Statistical Manual of Mental Disorders (DSM-IV) criteria for Post Traumatic Stress Disorder (PTSD), current.
3. Subject must have a PTSD Check List-5 (PCL-5) score greater than 38.
4. Subjects must be capable of providing informed consent.
5. Subjects must have an established residence and phone.
6. Subjects may be medicated or unmedicated.
Exclusion Criteria:
1. Dangerous or active suicidal ideation.
2. Pregnant or planning on becoming pregnant.
3. Substance abuse (cannot meet DSM criteria for substance abuse, no significant drug abuse within last 3 months, no major polysubstance abuse history, no history of dependence in last year, no drug use within last month).
4. Significant medical or neurological illness that might pose a risk to study enrollment or interfere with interpretation of study data.
5. Subjects must not have serious physical illnesses, neurological diseases or dementias.
6. Changes in psychiatric medication (e.g. dose or drug) within 6 weeks prior to enrollment.
7. History of an Axis 2 disorder, schizophrenia or schizoaffective disorder.
8. Contraindications for magnetic resonance imaging (MRI): Presence of a pacemaker, neurostimulator, or metal in head or neck.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT02545192
Study Brief:
Protocol Section:
NCT02545192