Cortisol Augmentation of Prolonged Exposure Therapy - Full Text View

Sponsor:	VISN3 Mental Illness Research, Education and Clinical Center
Information provided by:	Bronx VA Medical Center
ClinicalTrials.gov Identifier:	NCT00751855

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 Drug: placebo

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 Prolonged Exposure Therapy

Resource links provided by NLM:

MedlinePlus related topics: Memory

Drug Information available for: Hydrocortisone acetate Hydrocortisone Proctofoam-HC Hydrocortisone hemisuccinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone cypionate Cortisol succinate Cortisol 21-phosphate

U.S. FDA Resources

Further study details as provided by Bronx VA Medical Center:

Primary Outcome Measures:

Change in PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS) [ Time Frame: Baseline (Week 0), endpoint (week 11) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cognitive performance (learning and retention in an episodic memory task, attention and working memory) [ Time Frame: Baseline (Week 0), endpoint (week 11) ] [ Designated as safety issue: No ]
Other measures of clinical outcome, psychological state and functioning [ Time Frame: Approximately 1 week prior to starting therapy (Week 0) and approximately 1 week after completing 10 weeks of therapy (week 11) ] [ Designated as safety issue: No ]
Biological measures associated with PTSD severity [ Time Frame: Approximately 1 week prior to starting therapy (Week 0) and approximately 1 week after completing 10 weeks of therapy (week 11) ] [ Designated as safety issue: No ]

Enrollment:	11
Study Start Date:	July 2008
Study Completion Date:	February 2011
Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Prolonged Exposure therapy with Hydrocortisone	Behavioral: Prolonged Exposure therapy 10 weekly sessions Drug: Hydrocortisone 30mg 45 minutes prior to each PE session including imaginal exposure (8 total)
Placebo Comparator: 2 Prolonged Exposure therapy with placebo	Behavioral: Prolonged Exposure therapy 10 weekly sessions Drug: placebo placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Veterans who experienced a criterion A trauma while deployed, and a current diagnosis of PTSD with a minimum of 6 months
Capable of understanding, reading and writing English

Exclusion Criteria:

Incapable and/or unwilling to provide written informed consent prior to participation
Unwilling and/or unable to discontinue current psychotherapy
Regular use of psychotropic medication including antidepressants, benzodiazepines, lithium, mood stabilizers, over-the-counter supplements (melatonin, kava-kava, ephedra)
Regular use of oral or inhaled steroids
Significant illness (e.g., type I or II diabetes requiring the use of insulin, HIV, AIDS, seizure disorder, anemia, Lyme disease, etc.)
The veteran, the veteran's physician, or the study physician think that the veteran's clinical state necessitates the prompt initiation of pharmacotherapy or other treatment that would preclude involvement in the study
Morbid obesity (VMI > 40)
Clinically significant laboratory abnormalities as determine during medical clearance procedures
For women, a positive pregnancy test
Heavy smoking (more than 2 packs a day)
Substance and/or alcohol abuse and/or dependence within the previous 6 months
Response of 3 or 4 on the suicidality items of the HDRS or an assessed serious suicide risk
Current psychosocial problems that might interfere with treatment compliance
A lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, obsessive compulsive disorder or PTSD due to a trauma not sustained in the combat theater

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00751855

Locations

United States, New York
James J. Peters Veterans Affairs Medical Center
Bronx, New York, United States, 10468

Sponsors and Collaborators

VISN3 Mental Illness Research, Education and Clinical Center

More Information

No publications provided

Responsible Party:	Rachel Yehuda, James J. Peters VA Medical Center
ClinicalTrials.gov Identifier:	NCT00751855 History of Changes
Other Study ID Numbers:	YEH-08-044
Study First Received:	September 11, 2008
Last Updated:	July 29, 2011
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Cortisol succinate
Hydrocortisone acetate
Hydrocortisone

Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012