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
  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:


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
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, see Learn About Clinical Studies.

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 July 24, 2014