A Randomized Clinical Trial of Hydrocortisone Augmentation of Prolonged Exposure

Condition(s) targeted: Post Traumatic Stress Disorder

Intervention: Hydrocortisone augmented Prolonged Exposure Therapy (Other); Prolonged exposure therapy with placebo administration (Other)

Phase: N/A

Status: Recruiting

Sponsored by: Bronx VA Medical Center

Official(s) and/or principal investigator(s):
Rachel Yehuda, PhD, Principal Investigator, Affiliation: James J Peters VAMC/Mount Sinai School of Medicine

Overall contact:
Rachel Yehuda, PhD, Phone: 718-741-4000, Ext: 6964, Email: rachel.yehuda@va.gov

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.

Official title: Improving PTSD Outcomes in OIF/OEF Returnees: A Randomized Clinical Trial of Hydrocortisone Augmentation of Prolonged Exposure Therapy"

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Clinician Administered PTSD Scale (CAPS)

Clinician Administered PTSD Scale (CAPS)

Clinician Administered PTSD Scale (CAPS)

Secondary outcome:

Biological measures associated with PTSD

Biological measures associated with PTSD

Biological measures associated with PTSD

MATRICS Consensus Cognitive Battery (MCCB)

MATRICS Consensus Cognitive Battery (MCCB)

MATRICS Consensus Cognitive Battery (MCCB)

Other measures of clinical, psychological, and functional outcome

Other measures of clinical, psychological, and functional outcome

Other measures of clinical, psychological, and functional outcome

Minimum age: 18 Years. Maximum age: 89 Years. Gender(s): Both.

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

Rachel Yehuda, PhD, Phone: 718-741-4000, Ext: 6964, Email: rachel.yehuda@va.gov

James J. Peters Veterans Affairs Medical Center, Bronx, New York 10468, United States; Recruiting
Rachel Yehuda, PhD, Email: rachel.yehuda@va.gov

Starting date: April 2011
Last updated: November 27, 2013