Low-dose Cortisol in Chronic Posttraumatic Stress Disorder

Posttraumatic Stress Disorder Clinical Trial

Official title:

Low-dose Cortisol in Chronic Posttraumatic Stress Disorder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00362661
• Other study ID #: PTSD-06
• Status: Terminated
• Phase: N/A
• First received: August 9, 2006
• Last updated: January 11, 2010
• Start date: June 2007
• Est. completion date: December 2009

Study information

• Verified date: January 2010
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: SwissmedicSwitzerland: Ethical committee, Zürich Switzerland
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Cortisol
Cortisol 10 mg/d for 3 months

Locations

Country	Name	City	State
Switzerland	Department of Psychiatry, University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CAPS CGI		1 year	No