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

PTSD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01090518
• Other study ID #: LFT2009-02-1
• Status: Recruiting
• Phase: N/A
• First received: March 11, 2010
• Last updated: February 4, 2013
• Start date: February 2010

Study information

• Verified date: February 2013
• Source: Bronx VA Medical Center
• Contact: Rachel Yehuda, PhD
• Phone: 718-741-4000
• Email: rachel.yehuda[@]va.gov
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• PTSD
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Prolonged Exposure therapy
10 weekly sessions

Drug:
• Hydrocortisone
30mg 20 minutes prior to each PE session including imaginal exposure (8 total)

Behavioral:
• Prolonged Exposure therapy
10 weekly sessions

Locations

Country	Name	City	State
United States	James J. Peters Veterans Affairs Medical Center	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Bronx VA Medical Center	Lightfighter Trust

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS)		week 0	No
Primary	PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS)		week 10	No
Primary	PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS)		week 16	No
Secondary	Cognitive performance (learning and retention in an episodic memory task, attention and working memory)		week 0	No
Secondary	Cognitive performance (learning and retention in an episodic memory task, attention and working memory)		week 10	No
Secondary	Cognitive performance (learning and retention in an episodic memory task, attention and working memory)		week 16	No
Secondary	Other measures of clinical outcome, psychological state and functioning		week 0	No
Secondary	Other measures of clinical outcome, psychological state and functioning		week 10	No
Secondary	Other measures of clinical outcome, psychological state and functioning		week 16	No
Secondary	Biological measures associated with PTSD severity		week 0	No
Secondary	Biological measures associated with PTSD severity		week 10	No
Secondary	Biological measures associated with PTSD severity		week 16	No