Veteran Stress and Learning Study

Phase 4

Completed

• Conditions: Stress Disorders, Posttraumatic
• Interventions: Drug: Placebo; Drug: D-Cycloserine; Drug: Hydrocortisone

• Registration Number: NCT00674570
• Lead Sponsor: VA Office of Research and Development

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-05-06
• Study First Submitted QC: 2008-05-06
• Study First Posted: 2008-05-08
• Study Start: 2009-01-13
• Primary Completion: 2015-06-22
• Study Completion: 2015-06-22
• Results First Submitted: 2019-03-22
• Status Verified: 2019-05
• Results First Submitted QC: 2019-05-28
• Last Update Submitted: 2019-05-28
• Results First Posted: 2019-05-30
• Last Update Posted: 2019-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 3: Placebo	Placebo	Placebo
Arm 2: D-Cycloserine	D-Cycloserine	D-Cycloserine
Arm 1: Hydrocortisone	Hydrocortisone	Hydrocortisone

Primary Outcome Measures

Name	Time	Method
Proportion of Maximum Skin Conductance Response (SCR) in Microsiemens (µS)	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.

Trial Locations

Locations (1)

San Francisco VA Medical Center, San Francisco, CA; 🇺🇸 San Francisco, California, United States