Low-dose Cortisol in Chronic Posttraumatic Stress Disorder

This study has been terminated.
(Recruitment: Insufficient number of patients eligible for enrollment)
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00362661
First received: August 9, 2006
Last updated: January 11, 2010
Last verified: January 2010

August 9, 2006
January 11, 2010
June 2007
December 2009   (final data collection date for primary outcome measure)
CAPS CGI [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00362661 on ClinicalTrials.gov 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
20
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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00362661
PTSD-06
Not Provided
Dominique de Quervain, Prof. MD, University of Zurich
University of Zurich
Not Provided
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