Effects of Hydrocortisone and D-Cycloserine on Fear Extinction in Veterans With Posttraumatic Stress Disorder
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 111
- Locations
- 1
- Primary Endpoint
- Proportion of Maximum Skin Conductance Response (SCR) in Microsiemens (µS)
Study Overview
Brief Summary
This is a research study examining the use of two medications, Hydrocortisone and D-Cycloserine, compared to an inactive substance (placebo), on their ability to reduce fear responses and memory of fear in Veterans with symptoms of Posttraumatic Stress Disorder (PTSD). These responses will be tested using a fear learning and memory task administered by computer.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Veterans and civilians with an age range of 18 to 65 years
- •Participants must be physically healthy volunteers
Exclusion Criteria
- •Individuals who fall outside the age range
- •Individuals with medical conditions that would interfere with participation
- •Other criteria
Arms & Interventions
Arm 1: Hydrocortisone
Hydrocortisone
Intervention: Hydrocortisone (Drug)
Arm 2: D-Cycloserine
D-Cycloserine
Intervention: D-Cycloserine (Drug)
Arm 3: Placebo
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Proportion of Maximum Skin Conductance Response (SCR) in Microsiemens (µS)
Time Frame: 15 minute measurement intervals on Study Days 7, 9, and 16
Psychophysiology measurements occurred on day 7 for fear conditioning, day 9 for fear extinction, and day 11 for extinction retention. The primary outcome measures are presented for the first and last conditioned stimulus (CS) trials during fear conditioning and extinction and for the first 2 trials during retention. Conditioned Responses (CR): An SCR score was obtained for each CS by subtracting the mean skin conductance level (SCL) in microsiemens (µS) for the 2-s interval immediately preceding CS onset from the max SC level in µS during the 8-s CS presentation. Unconditioned Response (UCR): An SCR score for the UCR was obtained by subtracting the mean SCL in µS within 6-8 s following CS offset from the max increase in SC level during the .5-6.5 time interval following the CS offset, corresponding to the onset of the .5s US. SC responses were range corrected using each participant's maximum response to the UCS or CS during acquisition trials of the fear conditioning phase.
Secondary Outcomes
No secondary outcomes reported