A Clinical Trial for Post Traumatic Stress Disorder

NCT ID: NCT00554177

Last Updated: 2016-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2008-12-31

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.

Conditions

Post Traumatic Stress Disorder (PTSD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Medicane (mifepristone)

Group Type: EXPERIMENTAL

Medicane (mifepristone)

Intervention Type: DRUG

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

2

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Medicane (mifepristone)

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Antonia New

OTHER

Sponsor Role: lead

Responsible Party

Antonia New

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Antonia New, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Mount Sinai School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

GCO# 07-0900

Identifier Type: -

Identifier Source: org_study_id