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 @ 12:42 PM
Ignite Modification Date:
2025-12-24 @ 12:42 PM
NCT ID:
NCT00362661
Eligibility Criteria:
Inclusion Criteria:
* Female and male patients with chronic PTSD due to adult trauma; PTSD is diagnosed according to the DSM-IV, as measured with the CAPS
* Age between 18 and 60
Exclusion Criteria:
* History of disease states representing contraindications to glucocorticoid therapy (tuberculosis, gastritis, gastric- and duodenal ulcers, Cushing's disease, osteoporosis, hypertension, pregnancy (to exclude with a pregnancy test) and lactation, glaucoma, diabetes mellitus, thrombophilia, acute or chronic infections, hyperthyroidism, cirrhosis)
* Severe or chronic somatic diseases
* Topic glucocorticoid therapy (for large skin parts)
* Inhaled glucocorticoids
* Current psychotic, bipolar, substance-related, or severe personality disorder
* Current severe depressive disorder
* Severe cognitive impairment or a history of organic mental disorder
* Evidence of PTSD or depression immediately prior to the index trauma
* Prominent current suicidal or homicidal ideation
* Asylum seeking status
* Body weight \>20% above or below normal range
* Changes in psychopharmacologic or psychotherapeutic management less than 8 weeks before start of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00362661
Study Brief:
Protocol Section:
NCT00362661