NCT00362661TerminatedNot Applicable
Low-dose Cortisol in Chronic Posttraumatic Stress Disorder
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Zurich
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- CAPS CGI
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
CAPS CGI
Time Frame: 1 year
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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