Low-dose Cortisol in Chronic Posttraumatic Stress Disorder

• Status: Terminated
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this prospective, double-blind, placebo-controlled, cross-over study is to determine the therapeutic efficacy of low-dose cortisol for symptoms of chronic posttraumatic stress disorder.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Zurich
• Treatments: Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate

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