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WithdrawnNCT00706173Updated Jun 3, 2015

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

A Phase 4 interventional study of Hydrocortisone and Placebo in Post-traumatic Stress Disorder, sponsored by University of California, San Diego. Withdrawn at 1 site in United States. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-06-03.

Sponsored by University of California, San Diego · Phase 4, Interventional, and Treatment

Why this study was withdrawn
Unable to recruit eligible subjects for the trial.
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Male
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Study 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.

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Conditions studied

  • Post-traumatic Stress Disorder

Keywords

  • Post-traumatic stress disorder
  • PTSD
  • Cortisol
  • hydrocortisone
  • pharmacological treatment
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In context

Stress Disorders, Traumatic

1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.

Browse Stress Disorders, Traumatic studies →

Lead sponsor

University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

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)
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Hydrocortisone

    Drug: Hydrocortisone

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugHydrocortisone

    Hydrocortisone 10-20 mg PO daily for 4 weeks.

    Also known as: cortisol

  • DrugPlacebo

    Placebo "10-20 mg" PO daily for 4 weeks.

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What researchers measure

Primary outcomes

  1. Clinician Administered PTSD Scale (CAPS)

    Time frame: Week 0,2,4,6,8,10

  2. Clinical Global Impressions - Improvement (CGI-I)

    Time frame: Week 0,2,4,6,8,10

Secondary outcomes

  1. Sheehan Disability Inventory (SDI)

    Time frame: Week 0,4,6,10

  2. Brief Symptom Inventory - 18 item (BSI-18)

    Time frame: Week 0,2,4,6,8,10

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Study locations

1 site
  • University of California, San Diego
    La Jolla, California 92037, United States
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References and documents

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. PubMed 15285979 ↗
  • 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. PubMed 11750894 ↗
  • 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. PubMed 15013832 ↗
  • 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. PubMed 17081699 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00706173
Lead sponsor
University of California, San Diego
First posted
Jun 27, 2008
Start date
Aug 2009
Primary completion
Sep 2011 (estimated)
Completion
Sep 2011 (estimated)
Last update
Jun 3, 2015

Study contacts

Murray B Stein, MD, MPH
principal investigator · University of California, San Diego

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.

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