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he purpose of this study is to test whether a medication, called mifepristone (commonly known as the ³Morning-After-Pill²), can help to prevent emotional problems after someone has survived a traumatic experience. We are studying this medication for the treatment of Post-traumatic Stress disorder (PTSD.
PTSD is an emotional illness that can develop in people after they have experienced a traumatic event. It involves symptoms such as poor sleep, nightmares about the trauma, unwanted daytime memories of the trauma (flashbacks), jumpiness, and trouble looking forward to things in the future. Once people develop PTSD, the symptoms tend to last a very long time.
We are testing the idea that mifepristone, which blocks the effect of the hormones progesterone and cortisol, will help treat PTSD. Progesterone is a hormone made in the bodies of both men and women and its main role is in regulating the menstrual cycle and in pregnancy. Cortisol is also a hormone made in the body of both men and women and helps the body respond to stress. Cortisol also has a role in making emotional memories more intense than other memories. We are testing whether blocking the effect of cortisol with mifepristone as you recall your trauma may be able to decrease the intensity of your traumatic memories. This medication will not completely block out your memories of the traumatic experience but may decrease how much your thoughts are drawn back to the memory of the traumatic event.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Medicane (mifepristone) |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medicane (mifepristone) | Drug | 2 doses of 1200mg, Administered 2-3 days apart |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Administered PTSD Scale(CAPS) | once a week over eight weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonia New, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D003075 | Coitus |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D012725 | Sexual Behavior |
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| ID | Term |
|---|---|
| D015735 | Mifepristone |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Placebo |
| Drug |
2 doses of 1200mg, administered 2-3 days apart |
|
| D001519 | Behavior |
| D011083 |
| Polycyclic Compounds |