View Clinical Trial (Medical Research Study)
Cortisol Augmentation of a Psychological Treatment in Warfighters With Post Traumatic Stress Disorder (PTSD)
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Bronx |
| State: |
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New York |
| Zip Code: |
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10468 |
| Conditions: |
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PTSD |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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.
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| NCT ID: |
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NCT01090518 |
| Primary Contact: |
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Rachel Yehuda, PhD
Phone: 718-741-4000 ext. 6964
Email: rachel.yehuda@va.gov
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| Backup Contact: |
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N/A |
| Location Contact: |
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Bronx, New York 10468
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
| Modifications to this listing: |
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