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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
History of Changes
  Purpose

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 Intervention
Posttraumatic Stress Disorder
 Drug: Cortisol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Low-dose Cortisol in Chronic Posttraumatic Stress Disorder

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • CAPS CGI [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: June 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Cortisol
    Cortisol 10 mg/d for 3 months
    Other Name: Cortisol (10 mg), Galepharm, Küsnacht, Switzerland
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00362661

Locations
Switzerland
Department of Psychiatry, University Hospital Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
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
  More Information

Publications:

Responsible Party: Dominique de Quervain, Prof. MD, University of Zurich
ClinicalTrials.gov Identifier: NCT00362661     History of Changes
Other Study ID Numbers: PTSD-06
Study First Received: August 9, 2006
Last Updated: January 11, 2010
Health Authority: Switzerland: Swissmedic
Switzerland: Ethical committee, Zürich Switzerland

Keywords provided by University of Zurich:
PTSD
cortisol
memory
treatment

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
 Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on May 22, 2013