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Hydrocortisone + Prolonged Exposure for PTSD

N/A
Waitlist Available
Led By Rachel Yehuda, PhD
Research Sponsored by Bronx VA Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 to 89
Minimum PTSD severity of 60 (CAPS)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 23
Awards & highlights

Study Summary

This trial will study whether adding hydrocortisone to Prolonged Exposure therapy can help treat PTSD.

Who is the study for?
Veterans aged 18-89 with PTSD from deployment, who can read and write English, have a stable mental health medication regimen for at least one month, and are not pregnant. Excluded are those with unstable medical conditions, recent substance abuse, severe brain injury or certain psychiatric disorders.Check my eligibility
What is being tested?
The trial is testing if hydrocortisone can boost the effectiveness of Prolonged Exposure therapy for PTSD. Participants will either receive hydrocortisone or a placebo alongside their therapy sessions to see which combination is more effective.See study design
What are the potential side effects?
Hydrocortisone may cause side effects like mood swings, weight gain, increased blood sugar levels (especially in diabetics), sleep problems, weakened immune response and possible worsening of existing infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 89 years old.
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My PTSD severity score is 60 or higher.
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I have been on the same mental health medication for at least a month.
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I am between 18 and 89 years old.
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I have been on the same mental health medication for at least a month.
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My PTSD severity score is 60 or higher.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 23
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 23 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinician Administered PTSD Scale (CAPS)
Secondary outcome measures
Biological measures associated with PTSD
MATRICS Consensus Cognitive Battery (MCCB)
Other measures of clinical, psychological, and functional outcome

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Prolonged Exposure therapy with HydrocortisoneActive Control1 Intervention
Group II: Prolonged Exposure therapy with placeboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Bronx VA Medical CenterLead Sponsor
20 Previous Clinical Trials
1,226 Total Patients Enrolled
United States Department of DefenseFED
856 Previous Clinical Trials
225,535 Total Patients Enrolled
Rachel Yehuda, PhDPrincipal InvestigatorJames J Peters VAMC/Mount Sinai School of Medicine
1 Previous Clinical Trials
220 Total Patients Enrolled

Media Library

Prolonged Exposure Therapy Clinical Trial Eligibility Overview. Trial Name: NCT01525680 — N/A
Post-Traumatic Stress Disorder Research Study Groups: Prolonged Exposure therapy with Hydrocortisone, Prolonged Exposure therapy with placebo
Post-Traumatic Stress Disorder Clinical Trial 2023: Prolonged Exposure Therapy Highlights & Side Effects. Trial Name: NCT01525680 — N/A
Prolonged Exposure Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT01525680 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical research currently seeking participants?

"Unfortunately, according to clinicaltrials.gov the current recruitment period for this medical trial is inactive; it was first posted on April 1st 2011 and last updated November 27th 2013. Nevertheless, there are a plethora of other trials searching for participants at present with 416 studies actively recruiting patients now."

Answered by AI

Is this study open to applicants of any age up to 85 years old?

"This medical trial is seeking persons aged 18 to 89 years. There are 46 trials specifically for minors and 328 studies that involve patients over the age of retirement."

Answered by AI

Is it possible to participate in this clinical experiment?

"Potential participants must suffer from stress-related or traumatic disorders and fall into the 18 to 89 age range in order to qualify for this clinical trial. The total number of accepted candidates is limited to sixty individuals."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
James J. Peters Veterans Affairs Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I’m tired of always feeling bad, having flashbacks, and severe anxiety. I can’t.
PatientReceived 1 prior treatment
I’m tired of always feeling bad, having flashbacks, and severe anxiety. I can’t seem to shake my depression. I need some help here.
PatientReceived 2+ prior treatments
~4 spots leftby Mar 2025