Cortisol Augmentation of Prolonged Exposure Therapy

PTSD Clinical Trial

Official title:

Cortisol Augmentation of Prolonged Exposure Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00751855
• Other study ID #: YEH-08-044
• Status: Completed
• Phase: N/A
• First received: September 11, 2008
• Last updated: July 26, 2012
• Start date: July 2008
• Est. completion date: February 2011

Study information

• Verified date: October 2010
• Source: Bronx VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• 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: Completed
• Enrollment: 11
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• PTSD

Intervention

Behavioral:
• Prolonged Exposure therapy
10 weekly sessions

Drug:
• Hydrocortisone
30mg 45 minutes prior to each PE session including imaginal exposure (8 total)
• placebo
placebo

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
VISN 3 Mental Illness Research, Education and Clinical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS)		Baseline (Week 0), endpoint (week 11)
Secondary	Cognitive performance (learning and retention in an episodic memory task, attention and working memory)		Baseline (Week 0), endpoint (week 11)
Secondary	Other measures of clinical outcome, psychological state and functioning		Approximately 1 week prior to starting therapy (Week 0) and approximately 1 week after completing 10 weeks of therapy (week 11)
Secondary	Biological measures associated with PTSD severity		Approximately 1 week prior to starting therapy (Week 0) and approximately 1 week after completing 10 weeks of therapy (week 11)