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A Clinical Trial for Post Traumatic Stress Disorder (MATTER)

Primary Purpose

Post Traumatic Stress Disorder (PTSD)

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Medicane (mifepristone)

Placebo

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder (PTSD) focused on measuring sexual, combat, PTSD, Clinical trial, Trauma, PTSD treatment, PTSD medication, Post traumatic stress disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

Mount Sinai School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Medicane (mifepristone)

Placebo

Outcomes

Primary Outcome Measures

Clinical Administered PTSD Scale(CAPS)

Secondary Outcome Measures

Full Information

NCT ID

NCT00554177

First Posted

November 2, 2007

Last Updated

March 15, 2016

Sponsor

Antonia New

1. Study Identification

Unique Protocol Identification Number

NCT00554177

Brief Title

A Clinical Trial for Post Traumatic Stress Disorder

Acronym

MATTER

Official Title

Mifepristone After Trauma to Enhance Resilience

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Antonia New

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post Traumatic Stress Disorder (PTSD)

Keywords

sexual, combat, PTSD, Clinical trial, Trauma, PTSD treatment, PTSD medication, Post traumatic stress disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Medicane (mifepristone)

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

Medicane (mifepristone)

Intervention Description

2 doses of 1200mg, Administered 2-3 days apart

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

2 doses of 1200mg, administered 2-3 days apart

Primary Outcome Measure Information:

Title

Clinical Administered PTSD Scale(CAPS)

Time Frame

once a week over eight weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Antonia New, MD

Organizational Affiliation

Icahn School of Medicine at Mount Sinai

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mount Sinai School of Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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A Clinical Trial for Post Traumatic Stress Disorder

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