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Sponsored by: |
Mount Sinai School of Medicine |
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Information provided by: | Mount Sinai School of Medicine |
ClinicalTrials.gov Identifier: | NCT00554177 |
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.
Condition | Intervention | Phase |
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Post Traumatic Stress Disorder (PTSD) |
Drug: Medicane (mifepristone) Drug: Placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Mifepristone After Trauma to Enhance Resilience |
Estimated Enrollment: | 8 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | August 2008 |
Arms | Assigned Interventions |
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1: Experimental
Medicane (mifepristone)
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Drug: Medicane (mifepristone)
2 doses of 1200mg, Administered 2-3 days apart
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2: Placebo Comparator
Placebo
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Drug: Placebo
2 doses of 1200mg, administered 2-3 days apart
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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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Douglas Brodman, BA | 212-241-6603 | Douglas.brodman@mssm.edu |
United States, New York | |
Mount Sinai School of Medicine | Recruiting |
New York, New York, United States, 10029 |
Principal Investigator: | Antonia New, MD | Mount Sinai School of Medicine |
Study ID Numbers: | GCO# 07-0900 |
Study First Received: | November 2, 2007 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00554177 |
Health Authority: | United States: Food and Drug Administration |
sexual combat PTSD Clinical trial |
Trauma PTSD treatment PTSD medication Post traumatic stress disorder |
Anxiety Disorders Mental Disorders Wounds and Injuries Stress Disorders, Post-Traumatic |
Stress Mifepristone Stress Disorders, Traumatic |
Abortifacient Agents, Steroidal Contraceptives, Postcoital, Synthetic Disease Contraceptive Agents Hormone Antagonists Contraceptives, Oral Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female |
Reproductive Control Agents Luteolytic Agents Contraceptives, Postcoital Pharmacologic Actions Pathologic Processes Therapeutic Uses Abortifacient Agents Menstruation-Inducing Agents Contraceptives, Oral, Synthetic |