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

NCT00706173 | Withdrawn Phase 4

• 1 other identifier: 071982
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-traumatic Stress Disorder

Keywords

Post-traumatic stress disorder; PTSD; Cortisol; hydrocortisone; pharmacological treatment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Sheehan Disability Inventory (SDI)

  Week 0,4,6,10

• Brief Symptom Inventory - 18 item (BSI-18)

  Week 0,2,4,6,8,10

Study Arms (2)

Hydrocortisone

EXPERIMENTAL

Drug: Hydrocortisone

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Hydrocortisone DRUG

Hydrocortisone 10-20 mg PO daily for 4 weeks.

Also known as: cortisol

Hydrocortisone

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[CAPS\]

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

La Jolla, California, 92037, United States

Location

Related 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. doi: 10.1176/appi.ajp.161.8.1488.

  PMID: 15285979 BACKGROUND

• 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.

  PMID: 11750894 BACKGROUND

• 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.

  PMID: 15013832 BACKGROUND

• 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.

  PMID: 17081699 BACKGROUND

Related Links

• UCSD Anxiety Disorders Research Program

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• Murray B Stein, MD, MPH

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 25, 2008
• First Posted: June 27, 2008
• Study Start: August 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: June 3, 2015

Record last verified: 2011-08

Locations

US (1)