Recruiting

Hydrocortisone

Sponsor:

Bronx VA Medical Center

Code:

NCT01525680

Conditions

Post Traumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Hydrocortisone augmented Prolonged Exposure Therapy

Prolonged exposure therapy with placebo administration

Study Details

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.

Conditions

Post Traumatic Stress Disorder

Study ID

NCT01525680

Start date

Apr, 2011

Status verified date

Nov, 2013

Primary completion date

Sep, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Prolonged Exposure therapy with Hydrocortisone

placebo comparator: Prolonged Exposure therapy with placebo

Interventions

Hydrocortisone augmented Prolonged Exposure Therapy

11 sessions of PE. 20 minutes prior to final eight sessions, 30 mg hydrocortisone is administered.

Prolonged exposure therapy with placebo administration

11 sessions of PE. 20 minutes prior to final eight sessions, placebo is administered.

Primary outcome measure

  • Clinician Administered PTSD Scale (CAPS) [ Time Frame: week 0 ]
  • Clinician Administered PTSD Scale (CAPS) [ Time Frame: week 12 ]
  • Clinician Administered PTSD Scale (CAPS) [ Time Frame: week 23 ]

Central Contacts and Locations

Central contacts

Rachel Yehuda, PhD

718-741-4000rachel.yehuda@va.gov

Locations

James J. Peters Veterans Affairs Medical Center

Recruiting

Bronx, New York, United States, 10468

Contacts

Rachel Yehuda, PhD

rachel.yehuda@va.gov

More Information

Sponsor

Bronx VA Medical Center

Last update posted

Nov 28, 2013

Last verified

Nov, 2013

Keywords

  • PTSD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bronx VA Medical Center on 2013-11-28.