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 @ 9:43 PM
Ignite Modification Date:
2025-12-24 @ 9:43 PM
NCT ID:
NCT02053532
Eligibility Criteria:
For Patients with post-traumatic stress disorder (PTSD)
Inclusion criteria:
1. Age 18-55 years old
2. Currently diagnosed with PTSD and symptomatic with a Clinician-Administered PTSD Scale (CAPS) score \> 50
Exclusion criteria:
1. any primary Axis I disorder other than PTSD (e.g. psychosis)
2. medical or neurological illnesses likely to affect physiology or anatomy, i.e. uncontrolled hypertension, cardiovascular disorders
3. a history of drug (including benzodiazepines (BZD)) dependence (Diagnostic and Statistical Manual (DSM) IV criteria) within 1 year of the study and lasting longer than 2 years, except for alcohol dependence
4. current pregnancy (as documented by pregnancy testing at screening or on the day of PET imaging study)
5. current breast feeding
6. nicotine dependence
7. suicidal ideation or behavior
8. general magnetic resonance imaging (MRI) exclusion criteria, i.e. pacemakers, metals in the body;
9. Human immunodeficiency virus (HIV) (due to possible neuropsychiatric effects)
10. Hepatitis B or C (due to possible neuropsychiatric effects)
11. use of opioid medications within 2 weeks of the positron emission tomography (PET) study
12. having an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participation in the study
13. seriously claustrophobic
14. blood donation within 8 weeks prior to the study
15. positive alcohol breathalyzer test
16. Abnormal thyroid test indicated by thyroid stimulating hormone (TSH) \< .15 mlU/L and/or thyroxine (T4) \> 18 mcg/dL
17. Glucose \> 200 mg/dL on two separate days
For Healthy Subjects
Inclusion criteria:
1. Age 18-55 years old
2. No personal or first-degree family history of any Axis I diagnosis
Exclusion criteria:
1. . any history or current primary Axis I disorder ;
2. . medical or neurological illnesses likely to affect physiology or anatomy, i.e. uncontrolled hypertension, cardiovascular disorders;
3. . a history of drug (including benzodiazepines \[BZD\]) dependence (DSM IV criteria) within 1 year of the study and lasting longer than 2 years, except for alcohol dependence;
4. . current pregnancy (as documented by pregnancy testing at screening or on the day of PET imaging study);
5. . current breast feeding;
6. . nicotine dependence;
7. . suicidal ideation or behavior;
8. . general MRI exclusion criteria, i.e. pacemakers, metals in the body;
9. . HIV (due to possible neuropsychiatric effects);
10. . Hepatitis B or C (due to possible neuropsychiatric effects);
11. . use of opioid medications within 2 weeks of the PET study;
12. . having an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participation in the study;
13. . seriously claustrophobic;
14. . blood donation within 8 weeks prior to the study;
15. . positive alcohol breathalyzer test;
16. . Abnormal thyroid test indicated by TSH \< .15 mlU/L and/or T4 \> 18 mcg/dL;
17. . Glucose \> 200 mg/dL on two separate days;
18. . Does not have a lifetime history of trauma.
For Healthy Subjects with Trauma ("Trauma Controls")
Inclusion criteria:
1. . Age 18-55 years old;
2. . No personal or first-degree family history of any Axis I diagnosis;
3. . Has a lifetime history of trauma.
Exclusion criteria:
1. . any history or current primary Axis I disorder ;
2. . medical or neurological illnesses likely to affect physiology or anatomy, i.e. uncontrolled hypertension, cardiovascular disorders;
3. . a history of drug (including benzodiazepines \[BZD\]) dependence (DSM IV criteria) within 1 year of the study and lasting longer than 2 years, except for alcohol dependence;
4. . current pregnancy (as documented by pregnancy testing at screening or on the day of PET imaging study);
5. . current breast feeding;
6. . nicotine dependence;
7. . suicidal ideation or behavior;
8. . general MRI exclusion criteria, i.e. pacemakers, metals in the body;
9. . HIV (due to possible neuropsychiatric effects);
10. . Hepatitis B or C (due to possible neuropsychiatric effects);
11. . use of opioid medications within 2 weeks of the PET study;
12. . having an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participation in the study;
13. . seriously claustrophobic;
14. . blood donation within 8 weeks prior to the study;
15. . positive alcohol breathalyzer test;
16. . Abnormal thyroid test indicated by TSH \< .15 mlU/L and/or T4 \> 18 mcg/dL;
17. . Glucose \> 200 mg/dL on two separate days.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02053532
Study Brief:
Protocol Section:
NCT02053532