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A Randomized Clinical Trial of Hydrocortisone Augmentation of Prolonged Exposure

NCT01525680 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2013-11-28

No results posted yet for this study

Summary

This study seeks to examine the efficacy of hydrocortisone administration in the augmentation of the therapeutic effects of Prolonged Exposure (PE) therapy, an empirically tested treatment shown to be effective in the the treatment of posttraumatic stress disorder (PTSD). The augmentation builds on both the translation of neuroscience findings demonstrating the effects of glucocorticoids (GCs) on learning, and on empirical clinical findings from other investigators demonstrating beneficial effects of GCs in reducing traumatic memories in trauma-exposed persons.

Conditions

  • Post Traumatic Stress Disorder

Interventions

OTHER

Hydrocortisone augmented Prolonged Exposure Therapy

11 sessions of PE. 20 minutes prior to final eight sessions, 30 mg hydrocortisone is administered.

OTHER

Prolonged exposure therapy with placebo administration

11 sessions of PE. 20 minutes prior to final eight sessions, placebo is administered.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Bronx VA Medical Center

    lead FED

Principal Investigators

  • Rachel Yehuda, PhD · James J Peters VAMC/Mount Sinai School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2015-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01525680 on ClinicalTrials.gov