A Clinical Trial for Post Traumatic Stress Disorder

Post Traumatic Stress Disorder (PTSD) Clinical Trial

— MATTER  

Official title:

Mifepristone After Trauma to Enhance Resilience

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00554177
• Other study ID #: GCO# 07-0900
• Status: Completed
• Phase: Phase 1
• First received: November 2, 2007
• Last updated: March 15, 2016
• Start date: September 2007
• Est. completion date: December 2008

Study information

• Verified date: March 2016
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder (PTSD)
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Medicane (mifepristone)
2 doses of 1200mg, Administered 2-3 days apart
• Placebo
2 doses of 1200mg, administered 2-3 days apart

Locations

Country	Name	City	State
United States	Mount Sinai School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Antonia New

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Administered PTSD Scale(CAPS)		once a week over eight weeks	No

External Links

•   provides information on the Mood and Anxiety Disorders