Placebo-Controlled Trial of Hydrocortisone for Post-Traumatic Stress Disorder (PTSD) - Full Text View

Sponsored by:	University of California, San Diego
Information provided by:	University of California, San Diego
ClinicalTrials.gov Identifier:	NCT00706173

Purpose

Developing novel and effective pharmacologic interventions for this post-traumatic stress disorder is important. We propose to replicate findings of an earlier published pilot study using low dose hydrocortisone as a treatment for PTSD. In order to do so in a more meaningful way, we will conduct a larger but similar randomized double-blind placebo-controlled, cross-over design treatment study examining the use of low dose hydrocortisone (or placebo) for 4 weeks in combat veterans suffering from PTSD.

We hypothesize that, as described by Aerni et al. (2004), administration of daily hydrocortisone will lead to a reduction in PTSD symptom severity, but particularly for re-experiencing types (e.g., flashbacks, nightmares)of symptoms. We also hope to examine potential predictors and moderators of treatment response based on subjects' clinical characteristics, as well as serum cortisol and ACTH levels.

Condition	Intervention	Phase
Post-Traumatic Stress Disorder	Drug: Hydrocortisone Drug: Placebo	Phase IV

MedlinePlus related topics: Post-Traumatic Stress Disorder

Drug Information available for: Hydrocortisone Cortisol 21-phosphate Cortisol succinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone acetate Hydrocortisone cypionate Hydrocortisone hemisuccinate Proctofoam-HC

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Efficacy Study
Official Title:	A Randomized Double-Blind Placebo-Controlled Cross-Over Trial of Hydrocortisone for Post-Traumatic Stress Disorder

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:

Clinician Administered PTSD Scale (CAPS) [ Time Frame: Week 0,2,4,6,8,10 ] [ Designated as safety issue: No ]
Clinical Global Impressions - Improvement (CGI-I) [ Time Frame: Week 0,2,4,6,8,10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Sheehan Disability Inventory (SDI) [ Time Frame: Week 0,4,6,10 ] [ Designated as safety issue: No ]
Brief Symptom Inventory - 18 item (BSI-18) [ Time Frame: Week 0,2,4,6,8,10 ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	June 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Hydrocortisone Hydrocortisone 10-20 mg PO daily for 4 weeks followed by a two week washout and then switch to arm 2 for 4 weeks
2: Placebo Comparator	Drug: Placebo Placebo 10-20 mg PO daily for 4 weeks followed by a 2 week washout and then switch to arm 1 for 4 weeks

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male military veterans
Between the ages of 18-65 years old
Generally good medical health with no clinically significant abnormalities on physical examination, electrocardiogram, or laboratory findings
Ability to provide informed consent and comply with requirements of study protocol
No specific contraindications to hydrocortisone
Clinically predominant DSM-IV diagnosis of PTSD
Score of ≥ 40 on Clinician Administered PTSD Scale [CAPS]

Exclusion Criteria:

History of moderate to severe traumatic brain injury, seizure or organic mental illness
Lifetime history of schizophrenia, bipolar disorder, other psychotic disorder, or depression with a score of ≥ 16 on the 17-item Hamilton Depression Rating Scale (Hamilton, 1960), active suicidal ideation
Unstable medical illness
Subjects undergoing any formal psychotherapy within 3 months of enrollment
Subjects that meet criteria for substance dependence during the last 6 months
History of adverse reaction to corticosteroids.
Concurrent use of other psychotropic medication (e.g. benzodiazepines, antipsychotics)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00706173

Contacts

Contact: Lakshmi Ravindran, MD	858-534-7352	lravindran@ucsd.edu
Contact: Murray Stein, MD,MPH		mstein@ucsd.edu

Locations

United States, California
University of California, San Diego	Recruiting
La Jolla, California, United States, 92037
Contact: Lakshmi Ravindran, MD 858-534-7352 lravindran@ucsd.edu
Principal Investigator: Murray B Stein, MD, MPH
Sub-Investigator: Lakshmi Ravindran, MD

Sponsors and Collaborators

University of California, San Diego

Investigators

Principal Investigator:

Murray B Stein, MD,MPH

University of California, San Diego

More Information

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.

Schelling G, Briegel J, Roozendaal B, Stoll C, Rothenhäusler HB, Kapfhammer HP. The effect of stress doses of hydrocortisone during septic shock on posttraumatic stress disorder in survivors. Biol Psychiatry. 2001 Dec 15;50(12):978-85.

Schelling G, Kilger E, Roozendaal B, de Quervain DJ, Briegel J, Dagge A, Rothenhäusler HB, Krauseneck T, Nollert G, Kapfhammer HP. Stress doses of hydrocortisone, traumatic memories, and symptoms of posttraumatic stress disorder in patients after cardiac surgery: a randomized study. Biol Psychiatry. 2004 Mar 15;55(6):627-33.

Olff M, Güzelcan Y, de Vries GJ, Assies J, Gersons BP. HPA- and HPT-axis alterations in chronic posttraumatic stress disorder. Psychoneuroendocrinology. 2006 Nov;31(10):1220-30. Epub 2006 Nov 1.

Responsible Party:	University of California, San Diego ( Murray B. Stein )
Study ID Numbers:	071982
Study First Received:	June 25, 2008
Last Updated:	June 25, 2008
ClinicalTrials.gov Identifier:	NCT00706173
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Diego:

Post-traumatic stress disorder
PTSD
Cortisol
hydrocortisone
pharmacological treatment

Study placed in the following topic categories:

Hydrocortisone
Cortisol succinate
Anxiety Disorders
Mental Disorders

Stress Disorders, Post-Traumatic
Stress
Hydrocortisone acetate
Stress Disorders, Traumatic

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Pathologic Processes
Disease
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009