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

Primary Purpose

Post-traumatic Stress Disorder

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Hydrocortisone
Placebo
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-traumatic Stress Disorder focused on measuring Post-traumatic stress disorder, PTSD, Cortisol, hydrocortisone, pharmacological treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • University of California, San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Hydrocortisone

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Clinician Administered PTSD Scale (CAPS)
Clinical Global Impressions - Improvement (CGI-I)

Secondary Outcome Measures

Sheehan Disability Inventory (SDI)
Brief Symptom Inventory - 18 item (BSI-18)

Full Information

First Posted
June 25, 2008
Last Updated
June 2, 2015
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT00706173
Brief Title
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

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to recruit eligible subjects for the trial.
Study Start Date
August 2009 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
September 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, San Diego

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder
Keywords
Post-traumatic stress disorder, PTSD, Cortisol, hydrocortisone, pharmacological treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hydrocortisone
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Hydrocortisone
Other Intervention Name(s)
cortisol
Intervention Description
Hydrocortisone 10-20 mg PO daily for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo "10-20 mg" PO daily for 4 weeks.
Primary Outcome Measure Information:
Title
Clinician Administered PTSD Scale (CAPS)
Time Frame
Week 0,2,4,6,8,10
Title
Clinical Global Impressions - Improvement (CGI-I)
Time Frame
Week 0,2,4,6,8,10
Secondary Outcome Measure Information:
Title
Sheehan Disability Inventory (SDI)
Time Frame
Week 0,4,6,10
Title
Brief Symptom Inventory - 18 item (BSI-18)
Time Frame
Week 0,2,4,6,8,10

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murray B Stein, MD, MPH
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15285979
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.
Results Reference
background
PubMed Identifier
11750894
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.
Results Reference
background
PubMed Identifier
15013832
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.
Results Reference
background
PubMed Identifier
17081699
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.
Results Reference
background
Links:
URL
http://www.veryshy.org
Description
UCSD Anxiety Disorders Research Program

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

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