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Low-dose Cortisol in Chronic Posttraumatic Stress Disorder

Information source: University of Zurich
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Posttraumatic Stress Disorder

Intervention: Cortisol (Drug)

Phase: N/A

Status: Terminated

Sponsored by: University of Zurich

Official(s) and/or principal investigator(s):
Dominique de Quervain, MD, Principal Investigator, Affiliation: Division of Psychiatry Research, University of Zurich, Lenggstr. 31, 8032 Zurich, Switzerland
Ulrich Schnyder, MD, Principal Investigator, Affiliation: Department of Psychiatry, University Hospital Zurich, Culmannstrasse 8, 8091 Z├╝rich, Switzerland

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.

Clinical Details

Official title: Low-dose Cortisol in Chronic Posttraumatic Stress Disorder

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: CAPS CGI

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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

Locations and Contacts

Department of Psychiatry, University Hospital Zurich, Zurich 8091, Switzerland
Additional Information

Related 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.

Starting date: June 2007
Last updated: January 11, 2010

Page last updated: August 23, 2015

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