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:
NCT01691092
Eligibility Criteria:
Inclusion Criteria:
* 18-65 years old
* English speaking
* No other Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) diagnosis present, besides required as below.
Inclusion criteria for depressed subjects
* clinical diagnosis of a current or past depressive episode
* medication free for at least 2 weeks
* Score \>16 on Hamilton Depression Rating Scale (HDRS) if currently depressed or \<11 if not currently depressed
* treatment or non-treatment seeking who understand that this study is for research purposes only
Inclusion criteria for healthy controls
* no current, or history of, any DSM-IV diagnosis
* no first-degree relative with history of psychotic, mood, or anxiety disorder
Inclusion criteria for PTSD subjects
* current Post-Traumatic Stress Disorder, as determined by the Structured Clinical Interview for DSM-IV-Text Revision (TR) (SCID) patient research edition
* Clinician Administered PTSD Scale for DSM-IV-TR (CAPS) score of 50 or higher
Inclusion criteria for trauma control subjects
-history of trauma (meeting the criterion A of PTSD but not a full diagnosis of PTSD)
Exclusion Criteria:
* Current or past significant medical, neurological, or metabolic disorder or loss of consciousness for 5 minutes or more
* active, significant suicidal ideation
* implanted metallic devices or any Magnetic Resonance (MR) contraindications
* women who are pregnant or breastfeeding
* met DSM-IV criteria for alcohol/illicit substance dependence in their life-time or met alcohol/illicit substance abuse within past year
* history of prior radiation exposure for research purposes within the past year such that participation in this study would place them over FDA limits for annual radiation exposure. This guideline is an effective dose of 5 rem received per year
* blood donation within eight weeks of the start of the study
* radiation exposure at work that precludes study participation
* blood pressure \>140/80
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01691092
Study Brief:
Protocol Section:
NCT01691092