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 @ 12:36 PM
Ignite Modification Date:
2025-12-24 @ 12:36 PM
NCT ID:
NCT01914861
Eligibility Criteria:
Inclusion Criteria:
1. Persons 21-65 years old, who have been exposed to an event meeting the following DSM-IV criterion for Acute Stress Disorder:
Criteria A.1 and A.2 At least one of Criteria B1-5A.1
2. Who provide written, informed consent to participate in the study.
Exclusion Criteria:
1. Physical injury that would contraindicate participation or interfere with a subject's ability to give informed consent or cooperate with the screening or collection of initial measures. Examples include severe burn injury, life-threatening medical or surgical condition, condition requiring surgical intervention under general anesthesia, as indicated by Abbreviated Injury Scale (AIS), or by clinical judgment;
2. Head injury involving confusion, loss of consciousness, or amnesia;
3. Medical conditions such as extreme obesity, psoriasis, herpes, Cushing's syndrome, current infectious disease, current viral disease, tuberculosis, unstable diabetes or hypertension, myasthenia gravis, and heart failure. Persons taking medications that can interfere with the HPA axis (e.g.,steroids, betablockers,indomethacin) will be excluded;
4. Weight below 45 or above 120 kg.
5. Pregnancy (in suggestive cases, a pregnancy test will be performed);
6. Traumatic exposure that reflects ongoing victimization (e.g., domestic violence) to which the subject is likely to be re-exposed during the study period.
7. Overt psychopathology, intoxication, or under the influence of substances.
8. Evidence or history of schizophrenia, bipolar, other psychotic condition;
9. Prior history of PTSD;
10. Current or past history of dementia, amnesia, or other cognitive disorder predating trauma exposure;
11. Assessed serious suicide risk. -
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT01914861
Study Brief:
Protocol Section:
NCT01914861