Clinical trial NCT01525680: A Randomized Clinical Trial of Hydrocortisone Augmentation of Prolonged Exposure
Official title: Improving PTSD Outcomes in OIF/OEF Returnees: A Randomized Clinical Trial of Hydrocortisone Augmentation of Prolonged Exposure Therapy"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Traumatic Stress Disorder
Keywords: PTSD
Lead sponsor: Bronx VA Medical Center
Sponsor class: FED
Collaborators: name: United States Department of Defense
First posted: 2012-02-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study seeks to examine the efficacy of hydrocortisone administration in the augmentation of the therapeutic effects of Prolonged Exposure (PE) therapy, an empirically tested treatment shown to be effective in the the treatment of posttraumatic stress disorder (PTSD). The augmentation builds on both the translation of neuroscience findings demonstrating the effects of glucocorticoids (GCs) on learning, and on empirical clinical findings from other investigators demonstrating beneficial effects of GCs in reducing traumatic memories in trauma-exposed persons.


Eligibility criteria: Inclusion Criteria:

* Age 18 to 89
* Capable of understanding, reading, and writing in English
* OIF/OEF veteran with criterion-A trauma while deployed
* Minimum PTSD severity of 60 (CAPS)
* Unmedicated or on a stable psychotropic regimen (i.e., 1 or more months on the same regimen)

Exclusion Criteria:

* Lifetime history of psychotropic disorder, bipolar disorder, or obsessive compulsive disorder
* Moderate or severe traumatic brain injury (TBI)
* A medical or mental health problem other than PTSD that requires immediate clinical attention
* Substance abuse or dependence within the last 3 months
* Suicidal risk (as determined by response of 5 or 6 on the suicidality items of the Montgomery-Asberg Depression Rating Scale (MADRS)) and/or assessed suicide risk on the basis of clinical judgment
* Persons on a psychotropic medication regimen that has not been consistent for one month
* Presence of diabetes mellitus or any current unstable medical illness or condition that represents a contraindication to taking glucocorticoids (this will be determined by history and/or abnormal laboratory findings at medical clearance)
* Unwillingness to discontinue other specialized psychotherapy for PTSD during the 11 weeks of study treatment and the 3 month follow-up (Self-help (non-trauma focused) groups or supportive counseling can be continued but not initiated)
* Pregnant women or those planning to become pregnant within the study period will not be enrolled. Female participants must agree to use an effective method of birth control (i.e., oral contraceptive, Norplant, diaphragm, condom, or spermicide, abstinence) during the course of the study to ensure they do not become pregnant during the course of the study

Primary outcomes:
measure: Clinician Administered PTSD Scale (CAPS)
timeFrame: week 0
measure: Clinician Administered PTSD Scale (CAPS)
timeFrame: week 12
measure: Clinician Administered PTSD Scale (CAPS)
timeFrame: week 23
Secondary outcomes:
measure: Biological measures associated with PTSD
timeFrame: week 0
measure: Biological measures associated with PTSD
timeFrame: week 12
measure: Biological measures associated with PTSD
timeFrame: week 23
measure: MATRICS Consensus Cognitive Battery (MCCB)
timeFrame: week 0
measure: MATRICS Consensus Cognitive Battery (MCCB)
timeFrame: week 12
measure: MATRICS Consensus Cognitive Battery (MCCB)
timeFrame: week 23
measure: Other measures of clinical, psychological, and functional outcome
timeFrame: week 0
measure: Other measures of clinical, psychological, and functional outcome
timeFrame: week 12
measure: Other measures of clinical, psychological, and functional outcome
timeFrame: week 23
Other outcomes:
Locations:
city: Bronx
country: United States
facility: James J. Peters Veterans Affairs Medical Center
state: New York
Study officials:
affiliation: James J Peters VAMC/Mount Sinai School of Medicine
name: Rachel Yehuda, PhD
role: PRINCIPAL_INVESTIGATOR
References: