Low-dose Cortisol in Chronic Posttraumatic Stress Disorder
Information source: University of Zurich
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Posttraumatic Stress Disorder
Intervention: Cortisol (Drug)
Phase: N/A
Status: Terminated
Sponsored by: University of Zurich Official(s) and/or principal investigator(s):
Dominique de Quervain, MD, Principal Investigator, Affiliation: Division of Psychiatry Research, University of Zurich, Lenggstr. 31, 8032 Zurich, Switzerland
Ulrich Schnyder, MD, Principal Investigator, Affiliation: Department of Psychiatry, University Hospital Zurich, Culmannstrasse 8, 8091 Zürich, Switzerland
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.
Clinical Details
Official title: Low-dose Cortisol in Chronic Posttraumatic Stress Disorder
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: CAPS CGI
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
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
Locations and Contacts
Department of Psychiatry, University Hospital Zurich, Zurich 8091, Switzerland
Additional Information
Related publications: Aerni A, Traber R, Hock C, Roozendaal B, Schelling G, Papassotiropoulos A, Nitsch RM, Schnyder U, de Quervain DJ. Low-dose cortisol for symptoms of posttraumatic stress disorder. Am J Psychiatry. 2004 Aug;161(8):1488-90.
Starting date: June 2007
Last updated: January 11, 2010
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