Veteran Stress and Learning Study

Stress Disorders, Posttraumatic Clinical Trial

— VSL  

Official title:

Effects of Hydrocortisone and D-Cycloserine on Fear Extinction in Veterans With Posttraumatic Stress Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00674570
• Other study ID #: CDA-2-037-07F
• Secondary ID: H841-31915-01A
• Status: Completed
• Phase: Phase 4
• Start date: January 13, 2009
• Est. completion date: June 22, 2015

Study information

• Verified date: May 2019
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: June 22, 2015
• Est. primary completion date: June 22, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Stress Disorders, Posttraumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Hydrocortisone
25 mg/oral one hour prior to extinction task
• D-Cycloserine
50 mg/oral one hour prior to extinction task
• Placebo
One hour prior to extinction task

Locations

Country	Name	City	State
United States	San Francisco VA Medical Center, San Francisco, CA	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

Alexandra Kredlow M, Pineles SL, Inslicht SS, Marin MF, Milad MR, Otto MW, Orr SP. Assessment of skin conductance in African American and Non-African American participants in studies of conditioned fear. Psychophysiology. 2017 Nov;54(11):1741-1754. doi: 10.1111/psyp.12909. Epub 2017 Jul 4. — View Citation

Inslicht SS, Metzler TJ, Garcia NM, Pineles SL, Milad MR, Orr SP, Marmar CR, Neylan TC. Sex differences in fear conditioning in posttraumatic stress disorder. J Psychiatr Res. 2013 Jan;47(1):64-71. doi: 10.1016/j.jpsychires.2012.08.027. Epub 2012 Oct 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Maximum Skin Conductance Response (SCR) in Microsiemens (µS)	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.	15 minute measurement intervals on Study Days 7, 9, and 16