Trial of Hydrocortisone for Post-Traumatic Stress Disorder (PTSD)
NCT ID: NCT00706173
Last Updated: 2015-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE4
INTERVENTIONAL
2009-08-31
2011-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Hydrocortisone for Prevention of Post-Traumatic Stress Disorder
NCT02402114
Prevention of Posttraumatic Stress Disorder (PTSD) With Early Hydrocortisone Treatment: Pilot
NCT00597857
PTSD Prevention Using Oral Hydrocortisone
NCT04924166
A Randomized Clinical Trial of Hydrocortisone Augmentation of Prolonged Exposure
NCT01525680
Efficacy of Single Dose IV Hydrocortisone in Post Traumatic Stress Disorder (PTSD) Prevention
NCT00855270
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Hydrocortisone
Hydrocortisone
Hydrocortisone 10-20 mg PO daily for 4 weeks.
Placebo
Placebo
Placebo "10-20 mg" PO daily for 4 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Hydrocortisone
Hydrocortisone 10-20 mg PO daily for 4 weeks.
Placebo
Placebo "10-20 mg" PO daily for 4 weeks.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
18 Years
65 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of California, San Diego
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
University of California, San Diego
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Murray B Stein, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California, San Diego
La Jolla, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
UCSD Anxiety Disorders Research Program
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
071982
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.