Trial of Hydrocortisone for Post-Traumatic Stress Disorder (PTSD)

A Randomized Double-blind Placebo-controlled Cross-over Trial of Hydrocortisone for Post-traumatic Stress Disorder

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.

Study Overview

• Status: Withdrawn
• Conditions: Post-traumatic Stress Disorder
• Intervention / Treatment: Drug: Hydrocortisone; Drug: Placebo

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • University of California, San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; Placebo "10-20 mg" PO daily for 4 weeks.
EXPERIMENTAL: Hydrocortisone	Drug: Hydrocortisone; Hydrocortisone 10-20 mg PO daily for 4 weeks.; Other Names: cortisol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinician Administered PTSD Scale (CAPS)	Week 0,2,4,6,8,10
Clinical Global Impressions - Improvement (CGI-I)	Week 0,2,4,6,8,10

Secondary Outcome Measures

Outcome Measure	Time Frame
Sheehan Disability Inventory (SDI)	Week 0,4,6,10
Brief Symptom Inventory - 18 item (BSI-18)	Week 0,2,4,6,8,10

Collaborators and Investigators

• Sponsor: University of California, San Diego

Publications and helpful links

General 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. doi: 10.1176/appi.ajp.161.8.1488.
• 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.
• 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.
• 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.

Helpful Links

• UCSD Anxiety Disorders Research Program

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (ANTICIPATED): September 1, 2011
• Study Completion (ANTICIPATED): September 1, 2011

Study Registration Dates

• First Submitted: June 25, 2008
• First Submitted That Met QC Criteria: June 25, 2008
• First Posted (ESTIMATE): June 27, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): June 3, 2015
• Last Update Submitted That Met QC Criteria: June 2, 2015
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: PTSD; Cortisol; hydrocortisone; Post-traumatic stress disorder; pharmacological treatment
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Trauma and Stressor Related Disorders; Disease; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Anti-Inflammatory Agents; Hydrocortisone
• Other Study ID Numbers: 071982