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 @ 7:47 PM
Ignite Modification Date:
2025-12-24 @ 7:47 PM
NCT ID:
NCT02237703
Eligibility Criteria:
Inclusion criteria for patients with PTSD:
1. age 18-55 years old
2. currently diagnosed with PTSD and symptomatic with a Clinician-Administered PTSD Scale (CAPS) score \> 50.
Exclusion criteria for patients with PTSD:
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 of Mental Disorders (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. use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day, or cannot abstain from smoking during the prescribed tests
7. acute suicidal ideation or behavior, as defined by suicidal ideation and behavior during the 3-month period prior to enrollment in the study and while being enrolled in the study
8. general MRI exclusion criteria, i.e. pacemakers, metals in the body
9. Human immunodeficiency virus (HIV) (due to possible neuropsychiatric effects);
10. use of opioid medications within 2 weeks of the PET study
11. 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
12. seriously claustrophobic
13. blood donation within 8 weeks prior to the study.
Inclusion criteria for Healthy Subjects:
1. age 18-55 years old
2. no personal or first-degree family history of any Axis I diagnosis.
Exclusion criteria for Healthy Subjects:
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. use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day, or cannot abstain from smoking during the prescribed tests
7. acute suicidal ideation or behavior, as defined by suicidal ideation and behavior during the 3-month period prior to enrollment in the study and while being enrolled in the study
8. general MRI exclusion criteria, i.e. pacemakers, metals in the body
9. HIV (due to possible neuropsychiatric effects)
10. use of opioid medications within 2 weeks of the PET study
11. having an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participation in the study
12. seriously claustrophobic
13. blood donation within 8 weeks prior to the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02237703
Study Brief:
Protocol Section:
NCT02237703