Low-dose Cortisol in Chronic Posttraumatic Stress Disorder

NCT00362661 | Terminated

• 1 other identifier: PTSD-06
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Posttraumatic Stress Disorder

Keywords

PTSD; cortisol; memory; treatment

Outcome Measures

Primary Outcomes (1)

• CAPS CGI

  1 year

Interventions

Cortisol DRUG

Cortisol 10 mg/d for 3 months

Also known as: Cortisol (10 mg), Galepharm, Küsnacht, Switzerland

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Department of Psychiatry, University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related 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. doi: 10.1176/appi.ajp.161.8.1488.

  PMID: 15285979 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 9, 2006
• First Posted: August 10, 2006
• Study Start: June 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 12, 2010

Record last verified: 2010-01

Locations

CH (1)