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

Post-traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00706173
• Other study ID #: 071982
• Status: Withdrawn
• Phase: Phase 4
• First received: June 25, 2008
• Last updated: June 2, 2015
• Start date: August 2009
• Est. completion date: September 2011

Study information

• Verified date: August 2011
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Hydrocortisone
Hydrocortisone 10-20 mg PO daily for 4 weeks.
• Placebo
Placebo "10-20 mg" PO daily for 4 weeks.

Locations

Country	Name	City	State
United States	University of California, San Diego	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician Administered PTSD Scale (CAPS)		Week 0,2,4,6,8,10	No
Primary	Clinical Global Impressions - Improvement (CGI-I)		Week 0,2,4,6,8,10	No
Secondary	Sheehan Disability Inventory (SDI)		Week 0,4,6,10	No
Secondary	Brief Symptom Inventory - 18 item (BSI-18)		Week 0,2,4,6,8,10	No

External Links

•   UCSD Anxiety Disorders Research Program