A Clinical Trial for Post Traumatic Stress Disorder (MATTER)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Mount Sinai School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00554177
First received: November 2, 2007
Last updated: March 10, 2009
Last verified: May 2008
  Purpose

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
Post Traumatic Stress Disorder (PTSD)
Drug: Medicane (mifepristone)
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mifepristone After Trauma to Enhance Resilience

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Clinical Administered PTSD Scale(CAPS) [ Time Frame: once a week over eight weeks ]

Estimated Enrollment: 8
Study Start Date: September 2007
Estimated Study Completion Date: August 2008
Arms Assigned Interventions
Experimental: 1
Medicane (mifepristone)
Drug: Medicane (mifepristone)
2 doses of 1200mg, Administered 2-3 days apart
Placebo Comparator: 2
Placebo
Drug: Placebo
2 doses of 1200mg, administered 2-3 days apart

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or Female
  • Between 18 and 65 years old
  • Have experienced one or more traumatic events within the last year €Examples for traumatic events include physical or sexual assault, combat, natural disasters, witnessing death or injury of another person, bereavement €Currently experiencing severe symptoms of anxiety including flashbacks and intrusive memories of the traumatic event. €Not currently pregnant or intending to become pregnant. If sexually active, participants must be using an approved form of birth control
  • Medically healthy
  • Not currently taking psychiatric medications

Exclusion Criteria:

  • > 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)
  • 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.
  • Patient who in the investigator¹s judgment pose a current suicidal or homicidal risk
  • DSM-IV substance abuse or dependence within the past 90 days
  • Patient has been taking psychotropic medication in the last 2 weeks (5 weeks for fluoxetine) prior to screening. Psychotropic medications in the last 2 weeks prior to screening, fluoxetine in last 5 weeks.
  • Treatment with any other concomitant medication with primarily CNS activity
  • Treatment with any medication that the PI considers not acceptable for this study.
  • Patient regularly, or on average, drinks more than a) 28 units of alcohol per week for male patients, or b) 21 units of alcohol per week for female patients (1 unit = 1/2 pint of beer, or 1 glass of wine, or 1 measure of spirit)
  • Pregnancy or lactation*
  • Patient is currently receiving evidenced-based structured psychotherapy (e.g., cognitive-behavioral therapy, exposure therapy).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00554177

Contacts
Contact: Douglas Brodman, BA 212-241-6603 Douglas.brodman@mssm.edu

Locations
United States, New York
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Antonia New, MD Mount Sinai School of Medicine
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00554177     History of Changes
Other Study ID Numbers: GCO# 07-0900
Study First Received: November 2, 2007
Last Updated: March 10, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Mount Sinai School of Medicine:
sexual
combat
PTSD
Clinical trial
Trauma
PTSD treatment
PTSD medication
Post traumatic stress disorder

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Mifepristone
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents

ClinicalTrials.gov processed this record on August 28, 2014