A Randomized Clinical Trial of Hydrocortisone Augmentation of Prolonged Exposure

Post Traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01525680
• Other study ID #: YEH-09-087
• Status: Recruiting
• Phase: N/A
• First received: February 1, 2012
• Last updated: November 27, 2013
• Start date: April 2011

Study information

• Verified date: November 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: 60
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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

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

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• 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.

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	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician Administered PTSD Scale (CAPS)	Assessment of the severity of PTSD symptoms and of diagnosis of PTSD.	week 0	No
Primary	Clinician Administered PTSD Scale (CAPS)	Assessment of the severity of PTSD symptoms and of diagnosis of PTSD.	week 12	No
Primary	Clinician Administered PTSD Scale (CAPS)	Assessment of the severity of PTSD symptoms and of diagnosis of PTSD.	week 23	No
Secondary	Biological measures associated with PTSD	Measures of neuroendocrinology, genotyping, gene expression, and methylation at glucocorticoid receptor.	week 0	No
Secondary	Biological measures associated with PTSD	Measures of neuroendocrinology, genotyping, gene expression, and methylation at glucocorticoid receptor.	week 12	No
Secondary	Biological measures associated with PTSD	Measures of neuroendocrinology, genotyping, gene expression, and methylation at glucocorticoid receptor.	week 23	No
Secondary	MATRICS Consensus Cognitive Battery (MCCB)	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.	week 0	No
Secondary	MATRICS Consensus Cognitive Battery (MCCB)	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.	week 12	No
Secondary	MATRICS Consensus Cognitive Battery (MCCB)	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.	week 23	No
Secondary	Other measures of clinical, psychological, and functional outcome	Measures of symptom severity, trauma-related cognitions, and resiliency.	week 0	No
Secondary	Other measures of clinical, psychological, and functional outcome	Measures of symptom severity, trauma-related cognitions, and resiliency.	week 12	No
Secondary	Other measures of clinical, psychological, and functional outcome	Measures of symptom severity, trauma-related cognitions, and resiliency.	week 23	No