Low-dose Cortisol in Chronic Posttraumatic Stress Disorder
This study has been terminated.
(Recruitment: Insufficient number of patients eligible for enrollment)
Sponsor:
University of Zurich
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00362661
First received: August 9, 2006
Last updated: January 11, 2010
Last verified: January 2010
| Tracking Information | |||||||||
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| First Received Date ICMJE | August 9, 2006 | ||||||||
| Last Updated Date | January 11, 2010 | ||||||||
| Start Date ICMJE | June 2007 | ||||||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
CAPS CGI [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00362661 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Current Other Outcome Measures ICMJE | |||||||||
| Original Other Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Low-dose Cortisol in Chronic Posttraumatic Stress Disorder | ||||||||
| Official Title ICMJE | Low-dose Cortisol in Chronic Posttraumatic Stress Disorder | ||||||||
| 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. |
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| Detailed Description | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | |||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Posttraumatic Stress Disorder | ||||||||
| Intervention ICMJE | Drug: Cortisol
Cortisol 10 mg/d for 3 months
Other Name: Cortisol (10 mg), Galepharm, Küsnacht, Switzerland |
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| Study Arm (s) | |||||||||
| 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Terminated | ||||||||
| Estimated Enrollment ICMJE | 20 | ||||||||
| Completion Date | December 2009 | ||||||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 60 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Switzerland | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00362661 | ||||||||
| Other Study ID Numbers ICMJE | PTSD-06 | ||||||||
| Has Data Monitoring Committee | |||||||||
| Responsible Party | Dominique de Quervain, Prof. MD, University of Zurich | ||||||||
| Study Sponsor ICMJE | University of Zurich | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | University of Zurich | ||||||||
| Verification Date | January 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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