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The investigators propose to conduct a randomized double-blind, parallel-group, placebo-controlled trial of mifepristone in veterans with military-related posttraumatic stress disorder (PTSD). This study will examine the clinical, neuropsychological, and neuroendocrine effects of short-term treatment of mifepristone (600 mg/day for one week) to determine if this treatment is efficacious in improving PTSD symptoms, cognitive functioning, or other related clinical measures. Additionally, the investigators will observe whether baseline neuroendocrine activity, or other clinical or neuropsychological factors predict the response to mifepristone, and whether mifepristone-induced changes in neuroendocrine activity are associated with treatment outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | mifepristone |
|
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mifepristone | Drug | 600 mg/day x 1 week |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline on the total severity of the CAPS-2 and dichotomously defined clinical responder status. | baseline, endpoint, 4 week follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cognitive functioning as measured by the MATRICS neuropsychological test battery and self-reported measures of depression and PTSD. | baseline, endpoint, 4 week follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julia A. Golier, M.D. | Contact | 718-584-9000 | 5196 | julia.golier@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Julia A Golier, MD | JJP VAMC; Mount Sinai Sch of Med | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James J. Peters VA Medical Center | Recruiting | The Bronx | New York | 10468 | United States |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015735 | Mifepristone |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Drug |
placebo |
|
| D011083 |
| Polycyclic Compounds |