Low-dose Cortisol in Chronic Posttraumatic Stress Disorder

This study has been terminated.

( Recruitment: Insufficient number of patients eligible for enrollment )

First Received: August 9, 2006 Last Updated: January 11, 2010 History of Changes

Sponsor:	University of Zurich
Information provided by:	University of Zurich
ClinicalTrials.gov Identifier:	NCT00362661

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:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Low-dose Cortisol in Chronic Posttraumatic Stress Disorder

Resource links provided by NLM:

MedlinePlus related topics: Post-Traumatic Stress Disorder

Drug Information available for: Hydrocortisone acetate Hydrocortisone Proctofoam-HC Hydrocortisone hemisuccinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone cypionate Cortisol succinate Cortisol 21-phosphate

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:

Cortisol 10 mg/d for 3 months

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:

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.

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

Keywords provided by University of Zurich:

PTSD
cortisol
memory
treatment

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Disease
Hydrocortisone
Cortisol succinate
Stress
Stress Disorders, Traumatic
Pharmacologic Actions

Pathologic Processes
Anxiety Disorders
Mental Disorders
Therapeutic Uses
Stress Disorders, Post-Traumatic
Hydrocortisone acetate

ClinicalTrials.gov processed this record on February 08, 2010