A Clinical Trial for Post Traumatic Stress Disorder

NCT00554177 | Completed Phase 1 DMC

• 1 other identifier: GCO# 07-0900
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Traumatic Stress Disorder (PTSD)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Clinical Administered PTSD Scale(CAPS)

  once a week over eight weeks

Study Arms (2)

1

EXPERIMENTAL

Medicane (mifepristone)

Drug: Medicane (mifepristone)

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Medicane (mifepristone) DRUG

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

1

Placebo DRUG

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

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \> 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).

Sponsors & Collaborators

• Antonia New: lead

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Coitus; Wounds and Injuries

Interventions

Mifepristone

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Antonia New, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 2, 2007
• First Posted: November 6, 2007
• Study Start: September 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 17, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)