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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)
Must not have
Moderate or severe traumatic brain injury (TBI)
A medical or mental health problem other than PTSD that requires immediate clinical attention
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 23

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a moderate or severe brain injury.
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I have a health issue that needs urgent care besides PTSD.
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I have a history of mental health issues like bipolar or OCD.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinician Administered PTSD Scale (CAPS)
Secondary study objectives
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
21 Previous Clinical Trials
1,286 Total Patients Enrolled
United States Department of DefenseFED
917 Previous Clinical Trials
334,639 Total Patients Enrolled
Rachel Yehuda, PhDPrincipal InvestigatorJames J Peters VAMC/Mount Sinai School of Medicine
2 Previous Clinical Trials
280 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
~4 spots leftby Jan 2026
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