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Veteran Stress and Learning Study (VSL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00674570
Recruitment Status : Completed
First Posted : May 8, 2008
Results First Posted : May 30, 2019
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Stress Disorders, Posttraumatic Drug: Hydrocortisone Drug: D-Cycloserine Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Hydrocortisone and D-Cycloserine on Fear Extinction in Veterans With Posttraumatic Stress Disorder
Actual Study Start Date : January 13, 2009
Actual Primary Completion Date : June 22, 2015
Actual Study Completion Date : June 22, 2015


Arm Intervention/treatment
Experimental: Arm 1: Hydrocortisone
Hydrocortisone
Drug: Hydrocortisone
25 mg/oral one hour prior to extinction task

Experimental: Arm 2: D-Cycloserine
D-Cycloserine
Drug: D-Cycloserine
50 mg/oral one hour prior to extinction task

Placebo Comparator: Arm 3: Placebo
Placebo
Drug: Placebo
One hour prior to extinction task




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00674570


Locations
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United States, California
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States, 94121
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Sabra S Inslicht, PhD San Francisco VA Medical Center, San Francisco, CA
Publications:
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00674570    
Other Study ID Numbers: CDA-2-037-07F
H841-31915-01A ( Other Identifier: San Francisco VAMC )
First Posted: May 8, 2008    Key Record Dates
Results First Posted: May 30, 2019
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by VA Office of Research and Development:
Stress Disorders, Posttraumatic
Hydrocortisone
Cycloserine
Extinction, Psychological
PTSD
San Francisco
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Cycloserine
Hydrocortisone
Anti-Inflammatory Agents
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action