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:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT00102102
Eligibility Criteria:
INCLUSION CRITERIA:
PTSD Samples:
Twenty subjects (age 18-65) with current PTSD, as defined by DSM-IV criteria, of any ethnicity without other significant medical conditions will be selected.
Healthy Control Samples:
Twenty healthy subjects (age 18-65) without a known personal or family history of psychiatric disorders in first-degree relatives will be selected.
A control subject will be matched to each subject with PTSD for age, gender, and handedness, respectively.
They must not be actively using illicit drugs or engaged in heavy consumption of alcohol, had no metallic implants that are ferromagnetic, and competent to sign consent forms to participate in the study.
EXCLUSION CRITERIA:
Patients must not have taken antidepressant or other medications likely to alter SP-NK1 receptor system. Effective medications will not be discontinued for the purpose of this study.
Subjects will be excluded if they have:
1. DSM-IV Axis I diagnostic criteria other than PTSD and Major depression (All controls must not meet any of the Axis I diagnoses);
2. DSM-IV criteria for psychoactive substance abuse/dependence within six months;
3. take psychotropic medication in last 3 weeks (8 weeks for fluoxetine);
4. abnormal MRI other than minor atrophy;
5. abnormal laboratory test, including HIV test;
6. are currently pregnant or breast feeding (as documented by pregnancy testing at screening or at days of the scanning);
7. prior participation in other research protocols within the past year such that a radiation exposure together with the present study would exceed the annual limits (A total effective dose 5.0 rem in a year and a 5 rad per year to the lens of the eyes, gonads and blood-forming organs; and 15 rad annually for all other organs);
8. are unable to lay on one's back for PET/MRI scans (PET and MRI scans take approximately 5 and 1 hour, respectively);
9. any condition that increases risk for MRI (e.g., pacemaker, metallic foreign body in the eye, etc.);
10. individuals who recently donated blood;
11. serious suicidal ideation or behavior;
12. Xylocaine allergy;
13. positive HIV test.
For healthy subjects, exclusion criteria b) through m) are same to those for PTSD subjects. As for item a), subjects will be excluded if they meet any current DSM-IV Axis I diagnostic criteria.
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT00102102
Study Brief:
Protocol Section:
NCT00102102