Trial record 87 of 120 for: CYCLOSERINE OR SEROMYCIN

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Veteran Stress and Learning Study (VSL)

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ClinicalTrials.gov Identifier: NCT00674570

Recruitment Status : Completed

First Posted : May 8, 2008

Last Update Posted : January 23, 2019

Sponsor:

Information provided by (Responsible Party):

VA Office of Research and Development

Study Description

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

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	138 participants
Allocation:	Randomized
Intervention Model:	Factorial 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 :	July 1, 2008
Actual Primary Completion Date :	June 1, 2017
Actual Study Completion Date :	June 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Post-Traumatic Stress Disorder

Drug Information available for: Hydrocortisone acetate Hydrocortisone Cycloserine Hydrocortisone sodium succinate Hydrocortisone cypionate Hydrocortisone valerate Hydrocortisone probutate Proctofoam-HC

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

Skin Conductance Change [ Time Frame: Day 7, 9, 16 ]
A Coulbourn Modular Instrument System was used. Skin conductance was measured directly by a Coulbourn Isolated Skin Conductance coupler (S71-23) using a constant .5 V through 9 mm (sensor diameter) Sensor Medics Ag/AgCl electrodes placed on the hypothenar surface of the participant's non-dominant hand. The SC electrodes were separated by 14 mm. The SC level analog signal was digitized by a Coulbourn Lablinc Analog to Digital Converter (L25-12). A Microsoft Windows-based computer system was used for sampling and storing the digitized SC signal and controlling stimulus presentations.

Secondary Outcome Measures :

Heart Rate Change [ Time Frame: Day 7, 9, 16 ]
HR was recorded by standard limb electrocardiogram leads connected to a High Gain Bioamplifier (S75-01) inputting to a Coulbourn Tachometer (S77-26). Physiologic analog signals were digitized by a Coulbourn Lablinc Analog to Digital Converter (L25-12).
Corrugator EMG Change [ Time Frame: Day 7, 9, 16 ]
EMG in microvolts was. Three 4-mm (sensor diameter) Ag/AgCl electrodes were placed on the corrugator muscle/forehead. Impedance levels were kept below 10 k . The EMG signal was amplified, rectified, and filtered so as to retain the 10- to 500-Hz range, notch filtered at 60 Hz, sampled at 500-Hz, digitized for 4 s beginning with the stimulus onset and stored for analysis.

Eligibility Criteria

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

Contacts and Locations

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


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


Principal Investigator:	Sabra S Inslicht, PhD	San Francisco VA Medical Center, San Francisco, CA

More Information

Publications:

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.

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.


Responsible Party:	VA Office of Research and Development
ClinicalTrials.gov Identifier:	NCT00674570 History of Changes
Other Study ID Numbers:	CDA-2-037-07F H841-31915-01A ( Other Identifier: San Francisco VAMC )
First Posted:	May 8, 2008 Key Record Dates
Last Update Posted:	January 23, 2019
Last Verified:	January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No


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:


Cycloserine Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Trauma and Stressor Related Disorders Mental Disorders Hydrocortisone 17-butyrate 21-propionate Hydrocortisone acetate Cortisol succinate 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

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