Placebo-Controlled Trial of Hydrocortisone for Post-Traumatic Stress Disorder (PTSD)
Information source: University of California, San Diego
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post-Traumatic Stress Disorder
Intervention: Hydrocortisone (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of California, San Diego Official(s) and/or principal investigator(s):
Murray B Stein, MD,MPH, Principal Investigator, Affiliation: University of California, San Diego
Overall contact:
Lakshmi Ravindran, MD, Phone: 858-534-7352, Email: lravindran@ucsd.edu
Summary
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.
Clinical Details
Official title: A Randomized Double-Blind Placebo-Controlled Cross-Over Trial of Hydrocortisone for Post-Traumatic Stress Disorder
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Efficacy Study
Primary outcome: Clinician Administered PTSD Scale (CAPS)Clinical Global Impressions - Improvement (CGI-I)
Secondary outcome: Sheehan Disability Inventory (SDI)Brief Symptom Inventory - 18 item (BSI-18)
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Male.
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)
Locations and Contacts
Lakshmi Ravindran, MD, Phone: 858-534-7352, Email: lravindran@ucsd.edu
University of California, San Diego, La Jolla, California 92037, United States; Recruiting
Lakshmi Ravindran, MD, Phone: 858-534-7352, Email: lravindran@ucsd.edu
Murray B Stein, MD, MPH, Principal Investigator
Lakshmi Ravindran, MD, Sub-Investigator
Additional Information
Related 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.
Starting date: June 2008
Ending date: June 2010
Last updated: June 25, 2008
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