Cortisol Augmentation of a Psychological Treatment in Warfighters With Post Traumatic Stress Disorder (PTSD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Bronx VA Medical Center
Sponsor:
Collaborator:
Lightfighter Trust
Information provided by (Responsible Party):
Rachel Yehuda, Bronx VA Medical Center
ClinicalTrials.gov Identifier:
NCT01090518
First received: March 11, 2010
Last updated: February 4, 2013
Last verified: February 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
PTSD
Behavioral: Prolonged Exposure therapy
Drug: Hydrocortisone

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: Cortisol Augmentation of a Psychological Treatment in Warfighters With Post Traumatic Stress Disorder (PTSD)

Resource links provided by NLM:


Further study details as provided by Bronx VA Medical Center:

Primary Outcome Measures:
  • PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS) [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS) [ Time Frame: week 10 ] [ Designated as safety issue: No ]
  • PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS) [ Time Frame: week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cognitive performance (learning and retention in an episodic memory task, attention and working memory) [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • Cognitive performance (learning and retention in an episodic memory task, attention and working memory) [ Time Frame: week 10 ] [ Designated as safety issue: No ]
  • Cognitive performance (learning and retention in an episodic memory task, attention and working memory) [ Time Frame: week 16 ] [ Designated as safety issue: No ]
  • Other measures of clinical outcome, psychological state and functioning [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • Other measures of clinical outcome, psychological state and functioning [ Time Frame: week 10 ] [ Designated as safety issue: No ]
  • Other measures of clinical outcome, psychological state and functioning [ Time Frame: week 16 ] [ Designated as safety issue: No ]
  • Biological measures associated with PTSD severity [ Time Frame: week 0 ] [ Designated as safety issue: No ]
  • Biological measures associated with PTSD severity [ Time Frame: week 10 ] [ Designated as safety issue: No ]
  • Biological measures associated with PTSD severity [ Time Frame: week 16 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2010
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prolonged Exposure therapy with Hydrocortisone Behavioral: Prolonged Exposure therapy
10 weekly sessions
Drug: Hydrocortisone
30mg 20 minutes prior to each PE session including imaginal exposure (8 total)
Placebo Comparator: Prolonged Exposure therapy with placebo Behavioral: Prolonged Exposure therapy
10 weekly sessions

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A primary diagnosis of chronic PTSD according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic criteria, resulting from a deployment-related traumatic event, and a minimum PTSD severity of 50 (CAPS).
  • The veteran must either be unmedicated or on a stable psychotropic regimen (i.e., 1 or more months on the same regimen).

Exclusion Criteria:

  • Lifetime history of psychotic 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 10 weeks of study treatment and the 6 week 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: NCT01090518

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
Principal Investigator: Rachel Yehuda, PhD         
Sponsors and Collaborators
Bronx VA Medical Center
Lightfighter Trust
  More Information

No publications provided

Responsible Party: Rachel Yehuda, PhD, Professor of Neuroscience and Psychiatry, Bronx VA Medical Center
ClinicalTrials.gov Identifier: NCT01090518     History of Changes
Other Study ID Numbers: LFT2009-02-1
Study First Received: March 11, 2010
Last Updated: February 4, 2013
Health Authority: United States: Federal Government

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 September 16, 2014