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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00674570
First received: May 6, 2008
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

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 Intervention
Stress Disorders, Posttraumatic
Drug: Hydrocortisone
Drug: D-Cycloserine
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Hydrocortisone and D-Cycloserine on Fear Extinction in Veterans With Posttraumatic Stress Disorder

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Skin Conductance [ Time Frame: Day 7, 9, 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Heart Rate [ Time Frame: Day 7, 9, 16 ] [ Designated as safety issue: No ]
  • Eye Blink [ Time Frame: Day 7, 9, 16 ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: July 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Hydrocortisone
Drug: Hydrocortisone
25 mg/oral one hour prior to extinction task
Experimental: Arm 2
D-Cycloserine
Drug: D-Cycloserine
50 mg/oral one hour prior to extinction task
Placebo Comparator: Arm 3
Placebo
Drug: Placebo
One hour prior to extinction task

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00674570

Contacts
Contact: Sabra S Inslicht, PhD (415) 221-4810 ext 3341 sabra.inslicht@va.gov

Locations
United States, California
VA Medical Center, San Francisco Recruiting
San Francisco, California, United States, 94121
Contact: Sabra S Inslicht, PhD    415-221-4810 ext 3341    sabra.inslicht@va.gov   
Sub-Investigator: Charles R. Marmar, MD         
Principal Investigator: Sabra S. Inslicht, PhD         
Sponsors and Collaborators
Investigators
Principal Investigator: Sabra S. Inslicht, PhD VA Medical Center, San Francisco
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00674570     History of Changes
Other Study ID Numbers: H841-31915-01A
Study First Received: May 6, 2008
Last Updated: June 12, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Stress Disorders, Posttraumatic
Hydrocortisone
Cycloserine
Extinction, Psychological
PTSD
San Francisco

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Cycloserine
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Renal Agents
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on August 28, 2014