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Low-dose Cortisol in Chronic Posttraumatic Stress Disorder

Primary Purpose

Posttraumatic Stress Disorder

Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Cortisol
Sponsored by
University of Zurich
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring PTSD, cortisol, memory, treatment

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Psychiatry, University Hospital Zurich

Outcomes

Primary Outcome Measures

CAPS CGI

Secondary Outcome Measures

Full Information

First Posted
August 9, 2006
Last Updated
January 11, 2010
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT00362661
Brief Title
Low-dose Cortisol in Chronic Posttraumatic Stress Disorder
Official Title
Low-dose Cortisol in Chronic Posttraumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Terminated
Why Stopped
Recruitment: Insufficient number of patients eligible for enrollment
Study Start Date
June 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Zurich

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
PTSD, cortisol, memory, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Cortisol
Other Intervention Name(s)
Cortisol (10 mg), Galepharm, Küsnacht, Switzerland
Intervention Description
Cortisol 10 mg/d for 3 months
Primary Outcome Measure Information:
Title
CAPS CGI
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique de Quervain, MD
Organizational Affiliation
Division of Psychiatry Research, University of Zurich, Lenggstr. 31, 8032 Zurich, Switzerland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ulrich Schnyder, MD
Organizational Affiliation
Department of Psychiatry, University Hospital Zurich, Culmannstrasse 8, 8091 Zürich, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, University Hospital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
15285979
Citation
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.
Results Reference
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Low-dose Cortisol in Chronic Posttraumatic Stress Disorder

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