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

Phase 4

Withdrawn

• Conditions: Post-traumatic Stress Disorder
• Interventions: Drug: Placebo; Drug: Hydrocortisone

• Registration Number: NCT00706173
• Lead Sponsor: University of California, San Diego

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-25
• Study First Submitted QC: 2008-06-25
• Study First Posted: 2008-06-27
• Study Start: 2009-08
• Status Verified: 2011-08
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Last Update Submitted: 2015-06-02
• Last Update Posted: 2015-06-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Hydrocortisone	Hydrocortisone	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of California, San Diego; 🇺🇸 La Jolla, California, United States