Clinical trial NCT00706173: Trial of Hydrocortisone for Post-Traumatic Stress Disorder (PTSD)
Official title: A Randomized Double-blind Placebo-controlled Cross-over Trial of Hydrocortisone for Post-traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Post-traumatic Stress Disorder
Keywords: Post-traumatic stress disorder
PTSD
Cortisol
hydrocortisone
pharmacological treatment
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2008-06-27
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Developing novel and effective pharmacologic interventions for this post-traumatic stress disorder is important. The investigators 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, the investigators 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.

The investigators 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. The investigators also hope to examine potential predictors and moderators of treatment response based on subjects' clinical characteristics, as well as serum cortisol and ACTH levels.


Eligibility 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)

Primary outcomes:
measure: Clinician Administered PTSD Scale (CAPS)
timeFrame: Week 0,2,4,6,8,10
measure: Clinical Global Impressions - Improvement (CGI-I)
timeFrame: Week 0,2,4,6,8,10
Secondary outcomes:
measure: Sheehan Disability Inventory (SDI)
timeFrame: Week 0,4,6,10
measure: Brief Symptom Inventory - 18 item (BSI-18)
timeFrame: Week 0,2,4,6,8,10
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Murray B Stein, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Schelling G, Briegel J, Roozendaal B, Stoll C, Rothenhausler 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. doi: 10.1016/s0006-3223(01)01270-7.
citation: Schelling G, Kilger E, Roozendaal B, de Quervain DJ, Briegel J, Dagge A, Rothenhausler 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. doi: 10.1016/j.biopsych.2003.09.014.
citation: Olff M, Guzelcan 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. doi: 10.1016/j.psyneuen.2006.09.003. Epub 2006 Nov 1.