A Randomized Clinical Trial of Hydrocortisone Augmentation of Prolonged Exposure

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Bronx VA Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rachel Yehuda, Bronx VA Medical Center
ClinicalTrials.gov Identifier:
NCT01525680
First received: February 1, 2012
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Post Traumatic Stress Disorder
Other: Hydrocortisone augmented Prolonged Exposure Therapy
Other: Prolonged exposure therapy with placebo administration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving PTSD Outcomes in OIF/OEF Returnees: A Randomized Clinical Trial of Hydrocortisone Augmentation of Prolonged Exposure Therapy"

Resource links provided by NLM:


Further study details as provided by Bronx VA Medical Center:

Primary Outcome Measures:
  • Clinician Administered PTSD Scale (CAPS) [ Time Frame: week 0 ] [ Designated as safety issue: No ]
    Assessment of the severity of PTSD symptoms and of diagnosis of PTSD.

  • Clinician Administered PTSD Scale (CAPS) [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    Assessment of the severity of PTSD symptoms and of diagnosis of PTSD.

  • Clinician Administered PTSD Scale (CAPS) [ Time Frame: week 23 ] [ Designated as safety issue: No ]
    Assessment of the severity of PTSD symptoms and of diagnosis of PTSD.


Secondary Outcome Measures:
  • Biological measures associated with PTSD [ Time Frame: week 0 ] [ Designated as safety issue: No ]
    Measures of neuroendocrinology, genotyping, gene expression, and methylation at glucocorticoid receptor.

  • Biological measures associated with PTSD [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    Measures of neuroendocrinology, genotyping, gene expression, and methylation at glucocorticoid receptor.

  • Biological measures associated with PTSD [ Time Frame: week 23 ] [ Designated as safety issue: No ]
    Measures of neuroendocrinology, genotyping, gene expression, and methylation at glucocorticoid receptor.

  • MATRICS Consensus Cognitive Battery (MCCB) [ Time Frame: week 0 ] [ Designated as safety issue: No ]
    Measure of cognitive ability in the following domains: processing speed, attention, working memory (verbal and non-verbal), verbal learning, visual learning, reasoning and problem solving, and social cognition.

  • MATRICS Consensus Cognitive Battery (MCCB) [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    Measure of cognitive ability in the following domains: processing speed, attention, working memory (verbal and non-verbal), verbal learning, visual learning, reasoning and problem solving, and social cognition.

  • MATRICS Consensus Cognitive Battery (MCCB) [ Time Frame: week 23 ] [ Designated as safety issue: No ]
    Measure of cognitive ability in the following domains: processing speed, attention, working memory (verbal and non-verbal), verbal learning, visual learning, reasoning and problem solving, and social cognition.

  • Other measures of clinical, psychological, and functional outcome [ Time Frame: week 0 ] [ Designated as safety issue: No ]
    Measures of symptom severity, trauma-related cognitions, and resiliency.

  • Other measures of clinical, psychological, and functional outcome [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    Measures of symptom severity, trauma-related cognitions, and resiliency.

  • Other measures of clinical, psychological, and functional outcome [ Time Frame: week 23 ] [ Designated as safety issue: No ]
    Measures of symptom severity, trauma-related cognitions, and resiliency.


Estimated Enrollment: 60
Study Start Date: April 2011
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prolonged Exposure therapy with Hydrocortisone Other: Hydrocortisone augmented Prolonged Exposure Therapy
11 sessions of PE. 20 minutes prior to final eight sessions, 30 mg hydrocortisone is administered.
Placebo Comparator: Prolonged Exposure therapy with placebo Other: Prolonged exposure therapy with placebo administration
11 sessions of PE. 20 minutes prior to final eight sessions, placebo is administered.

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01525680

Contacts
Contact: Rachel Yehuda, PhD 718-741-4000 ext 6964 rachel.yehuda@va.gov

Locations
United States, New York
James J. Peters Veterans Affairs Medical Center Recruiting
Bronx, New York, United States, 10468
Contact: Rachel Yehuda, PhD       rachel.yehuda@va.gov   
Sponsors and Collaborators
Bronx VA Medical Center
Investigators
Principal Investigator: Rachel Yehuda, PhD James J Peters VAMC/Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Rachel Yehuda, MHPCCD, Bronx VA Medical Center
ClinicalTrials.gov Identifier: NCT01525680     History of Changes
Other Study ID Numbers: YEH-09-087
Study First Received: February 1, 2012
Last Updated: November 27, 2013
Health Authority: United States: Federal Government

Keywords provided by Bronx VA Medical Center:
PTSD

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Anxiety Disorders
Mental Disorders
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on October 01, 2014