Expired Study
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Clinical Trial 2676

New York, NY 10029


Study Summary:

You are being asked to participate in a research study. The purpose of this study is to test whether a medication, called mifepristone (commonly known as the “Morning-After-Pill”), can help to prevent emotional problems after someone has survived a traumatic experience. Mifepristone is a medication that is approved by the Food and Drug Administration (FDA) for the medical termination of an early pregnancy. We are not using mifepristone for that purpose in this study and you will not be eligible for the study if you are pregnant. We are studying this medication for the treatment of Post-traumatic Stress disorder (PTSD). This medication is not approved by the FDA for the treatment of Post traumatic Stress disorder. We are also using this medication at a higher dose than is used for termination of pregnancy.

We are trying to find out whether mifepristone can help to improve your PTSD symptoms. 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.

You qualify for participation because you are between the ages of 18 and 65, have experienced a serious trauma in the past year and have developed Post Traumatic Stress Disorder.


Qualified Participants Must:

• Be male or female between the ages of 18 and 65
• Have exposure to Index Trauma within one year of entry
• Not have lifetime or current diagnosis of schizophrenia or other psychotic disorder, bipolar disorder, or current Axis I disorder (except for major depression secondary to the PTSD)
• Not have current evidence or history of significant unstable medical illness or organic brain impairment, including stroke, CNS tumor, demyelinating disease, cardiac, pulmonary, gastrointestinal, or renal or hepatic impairment
• Not have substance abuse or dependence within the past 90 days
• Not have psychotropic medication or other medications in the last 2 weeks (5 weeks for fluoxetine) prior to screening.
• Not be pregnant or lactating
• Not be currently receiving structured psychotherapy (e.g., cognitive-behavioral therapy).


Qualified Participants May Receive:

• Visit #1: One Screening/Diagnostic Session with self-reports and interviews about how you are feeling and functioning as well as questions about your psychiatric history and functioning throughout your life (3-4 hours).

• Visit #2: A Medical Evaluation, (1 hour) You will return at your earliest convenience for a medical evaluation, which will include a physical exam and the the drawing of a blood sample from a vein in your arm. The total amount of blood drawn will not exceed 6 teaspoons. The blood will be drawn for a complete blood count, liver and kidney function tests, and a pregnancy test for women. You will have an electrocardiogram (a test of your heart rhythm, where you will lie down and have 12 patches placed on your body for about 5 minutes) and a urine drug test.

• Visit #3: Medication/Review of your experience: (90 min) Once the results of your medical exam have been reviewed by Dr. New, you will come into the clinic at your earliest convenience. A blood pressure cuff will be placed on your arm, a pulse-measuring clip on your finger and small electrodes (thin wires) will be attached with an adhesive tape to two fingers of one hand to record skin conductance (measure of sweating). If you are female, you will be asked to give a urine sample for a pregnancy test prior to receiving the medication. We will also ask you to use a cotton swab to collect a small sample of your saliva to measure the stress hormone, cortisol. You will do this when you first come into the lab and before you leave. You will then be given six pills of the study medication (1200 mg total) one hour prior to working with a psychologist to prepare a detailed story about what has happened to you. The psychologist will be asking you to recount in detail the trauma experience that you recall most and that comes back to you mot often as unwanted memories. This interview will be audiotaped. The taping of your study is a necessary part of the study so that we may play the tape back to you in subsequent visits. They will be kept private and is only taped in order to play it back to you in subsequent weeks. The audiotapes will be stored in a locked room and only Dr. New and her associates will have access to them. The audiotape will be destroyed after you complete Visit 8. If you do not complete the study for any reason the tapes will be destroyed immediately. You will be asked to fill out a number of questionnaires including the Davidson Trauma Scale (DTS) and the Impact of Events Scale (IES).

• Visits #4: Follow-up assessments and monitoring: (90 minutes) two-three days later you will once again be given six pills of the study medication (1200 mg total) one hour prior to listening to the story that you and the psychologist prepared from the prior visit while we monitor your heart rate, blood pressure and skin conductance as we did in Visit #3. In addition, we will ask you a number of questions and fill out questionnaires similar to the ones that you filled out at the beginning of the study. Immediately after hearing the story, you will once again be asked to fill out the Davidson Trauma Scale (DTS). Once again, we will ask you to use a cotton swab to collect a small sample of your saliva to measure the stress hormone, cortisol. You will do this when you first come into the lab and before you leave.

• Visits #5: Follow-up assessments and monitoring: (90 minutes) One week later, you will once again hear the story that you and the psychologist prepared approximately ten days earlier while we monitor your heart rate, blood pressure and skin conductance as we did in Visit #3. In addition, we will ask you a number of questions and fill out questionnaires similar to the ones that you filled out at the beginning of the study. Once again, we will ask you to use a cotton swab to collect a small sample of your saliva to measure the stress hormone, cortisol. You will do this when you first come into the lab and before you leave.

• Visits 6-8: Follow-up assessments: (60 minutes) You will be asked to come in weekly to fill out the self report measures and answer questions about your symptoms, but will not hear the story of your trauma again.


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.