Low-dose Cortisol in Chronic Posttraumatic Stress Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00362661
Recruitment Status : Terminated (Recruitment: Insufficient number of patients eligible for enrollment)
First Posted : August 10, 2006
Last Update Posted : January 12, 2010
Information provided by:
University of Zurich

August 9, 2006
August 10, 2006
January 12, 2010
June 2007
December 2009   (Final data collection date for primary outcome measure)
CAPS CGI [ Time Frame: 1 year ]
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Complete list of historical versions of study NCT00362661 on Archive Site
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Low-dose Cortisol in Chronic Posttraumatic Stress Disorder
Low-dose Cortisol in Chronic Posttraumatic Stress Disorder
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.
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Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Posttraumatic Stress Disorder
Drug: Cortisol
Cortisol 10 mg/d for 3 months
Other Name: Cortisol (10 mg), Galepharm, Küsnacht, Switzerland
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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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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December 2009
December 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Dominique de Quervain, Prof. MD, University of Zurich
University of Zurich
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Principal Investigator: Dominique de Quervain, MD Division of Psychiatry Research, University of Zurich, Lenggstr. 31, 8032 Zurich, Switzerland
Principal Investigator: Ulrich Schnyder, MD Department of Psychiatry, University Hospital Zurich, Culmannstrasse 8, 8091 Zürich, Switzerland
University of Zurich
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP