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Hydrocortisone + Prolonged Exposure Therapy for PTSD

N/A
Waitlist Available
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
Be older than 18 years old
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 up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 100 Other Conditions

Summary

This trial is testing whether adding hydrocortisone to Prolonged Exposure therapy, an effective treatment for PTSD, will make the therapy more effective.

Who is the study for?
This trial is for veterans with chronic PTSD from deployment-related trauma, who are either unmedicated or on a stable psychotropic regimen for at least one month. They must have a minimum PTSD severity score and cannot have certain mental health conditions, severe TBI, recent substance abuse, unstable medical illnesses, or be pregnant.
What is being tested?
The study tests if hydrocortisone can boost the effectiveness of Prolonged Exposure therapy in treating PTSD. It's based on findings that glucocorticoids help with learning and reducing traumatic memories. Participants will receive this combination to see if it helps more than therapy alone.
What are the potential side effects?
Hydrocortisone may cause side effects like mood swings, weight gain, increased blood sugar levels (especially important for diabetics), insomnia, weakened immune response making you more prone to infections, and possible stomach ulcers.

Eligibility Criteria

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, not related to PTSD.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 100 Other Conditions
This treatment demonstrated efficacy for 100 other conditions.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Prolonged Exposure therapy with HydrocortisoneActive Control2 Interventions
Group II: Prolonged Exposure therapy with placeboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Lightfighter TrustUNKNOWN
Bronx VA Medical CenterLead Sponsor
21 Previous Clinical Trials
1,296 Total Patients Enrolled

Media Library

Prolonged Exposure therapy Clinical Trial Eligibility Overview. Trial Name: NCT01090518 — N/A
Post-Traumatic Stress Disorder Research Study Groups: Prolonged Exposure therapy with placebo, Prolonged Exposure therapy with Hydrocortisone
Post-Traumatic Stress Disorder Clinical Trial 2023: Prolonged Exposure therapy Highlights & Side Effects. Trial Name: NCT01090518 — N/A
Prolonged Exposure therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT01090518 — N/A
~3 spots leftby Jan 2026
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