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Corticosteroid

1 for Post-Traumatic Stress Disorder

Phase 2
Waitlist Available
Led By Julia A Golier, MD
Research Sponsored by James J. Peters Veterans Affairs Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, endpoint, 4 week follow-up
Awards & highlights

Study Summary

The investigators propose to conduct a randomized double-blind, parallel-group, placebo-controlled trial of mifepristone in veterans with military-related posttraumatic stress disorder (PTSD). This study will examine the clinical, neuropsychological, and neuroendocrine effects of short-term treatment of mifepristone (600 mg/day for one week) to determine if this treatment is efficacious in improving PTSD symptoms, cognitive functioning, or other related clinical measures. Additionally, the investigators will observe whether baseline neuroendocrine activity, or other clinical or neuropsychological factors predict the response to mifepristone, and whether mifepristone-induced changes in neuroendocrine activity are associated with treatment outcome.

Eligible Conditions
  • Post-Traumatic Stress Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, endpoint, 4 week follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, endpoint, 4 week follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline on the total severity of the CAPS-2 and dichotomously defined clinical responder status.
Secondary outcome measures
Body Weight Changes

Side effects data

From undefined Phase 3 trial • 50 Patients • NCT00569582
50%
Thyroid function test abnormal
50%
Decreased appetite
48%
Fatigue
48%
Nausea
44%
Headache
34%
Blood potassium decreased
30%
Arthralgia
26%
Vomiting
26%
Oedema peripheral
24%
Hypertension
22%
Dizziness
18%
Dry mouth
16%
Back pain
16%
Dyspnoea
14%
Pain
14%
Sinusitis
14%
Myalgia
12%
Nasopharyngitis
12%
Diarrhoea
12%
Pain in extremity
10%
Constipation
10%
Somnolence
10%
Anxiety
10%
Anorexia
8%
Gastrooesophageal reflux disease
8%
Dry skin
8%
Ecchymosis
8%
Urinary tract infection
8%
Blood triglycerides increased
8%
Muscular weakness
8%
Cushing's syndrome
8%
Vision blurred
8%
Vaginal haemorrhage
8%
Pharyngolaryngeal pain
6%
Acne
6%
Pollakiuria
6%
Asthenia
6%
Oedema
6%
Malaise
6%
Pitting oedema
6%
Thirst
6%
Flank pain
6%
Musculoskeletal chest pain
6%
Insomnia
6%
Contusion
6%
Upper respiratory tract infection
6%
Hypoglycaemia
6%
Hot flush
6%
Metrorrhagia
6%
Cough
4%
Respiratory Failure
4%
adrenal carcinoma
2%
Gastritis Erosive
2%
Foot Fracture
2%
Intracranial Aneurysm
2%
Confusional State
2%
Orthostatic Hypotension
2%
Blood Potassium Decreased
2%
Pulmonary Oedema
2%
Subcutaneous Abscess
2%
Angina Pectoris
2%
Renal Failure Acute
2%
neuroendocrine carcinoma
2%
neoplasm progression
2%
Adrenal Insufficiency
2%
Legionella pneumonia
2%
Pulmonary Embolism
2%
Cardiomyopathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mifepristone

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: 1Experimental Treatment1 Intervention
mifepristone
Group II: 2Placebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mifepristone
FDA approved

Find a Location

Who is running the clinical trial?

James J. Peters Veterans Affairs Medical CenterLead Sponsor
57 Previous Clinical Trials
2,820 Total Patients Enrolled
Julia A Golier, MDPrincipal InvestigatorJJP VAMC; Mount Sinai Sch of Med
1 Previous Clinical Trials
81 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Trial of Mifepristone in Combat Veterans With Posttraumatic Stress Disorder
Julia A. Golier, M.D. 2008. "Trial of Mifepristone in Combat Veterans With Posttraumatic Stress Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00833339.
All > Trauma
~5 spots leftby Apr 2025
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