MATTER: A Clinical Trial for Post Traumatic Stress Disorder

Sponsor

Antonia New (Other)

Overall Status

Completed

CT.gov ID

NCT00554177

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Post Traumatic Stress Disorder (PTSD)	Drug: Medicane (mifepristone) Drug: Placebo	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Mifepristone After Trauma to Enhance Resilience

Study Start Date :

Sep 1, 2007

Actual Primary Completion Date :

Sep 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Clinical Administered PTSD Scale(CAPS) [once a week over eight weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).