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

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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Drug: Cortisol Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Low-dose Cortisol in Chronic Posttraumatic Stress Disorder
Study Start Date : June 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Intervention Details:
  • Drug: Cortisol
    Cortisol 10 mg/d for 3 months
    Other Name: Cortisol (10 mg), Galepharm, Küsnacht, Switzerland

Primary Outcome Measures :
  1. CAPS CGI [ Time Frame: 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00362661

Department of Psychiatry, University Hospital Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
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

Responsible Party: Dominique de Quervain, Prof. MD, University of Zurich Identifier: NCT00362661     History of Changes
Other Study ID Numbers: PTSD-06
First Posted: August 10, 2006    Key Record Dates
Last Update Posted: January 12, 2010
Last Verified: January 2010

Keywords provided by University of Zurich:

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Anti-Inflammatory Agents