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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00674570
First received: May 6, 2008
Last updated: March 6, 2013
Last verified: March 2013
History of Changes
  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:

U.S. FDA Resources

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: 120
Study Start Date: July 2008
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (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
  • Participants must meet DSM-IV criteria for full current PTSD or subsyndromal PTSD (as indexed by the CAPS criteria or with a CAPS score > 30 and meeting 2 of 3 of B, C, and D symptom clusters) of at least 3 months duration related to trauma

Exclusion Criteria:

  • Active suicidal intention, schizophrenia, schizoaffective disorder, alcohol dependence or substance abuse or dependence within the past 3 months, bipolar disorder, or seizure disorders
  • Neurological disorder, severe head injury systemic illness affecting CNS function, or medically unstable injuries
  • Psychotropic medications, including alpha and beta adrenergic agents, antipsychotics, benzodiazepines, mood stabilizers, anticonvulsants, antihypertensive medication, sympathomimetic medication, steroid medication, or any other general medications that could influence psychophysiology
  • Current ongoing trauma or recent trauma in the last 3 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00674570

Locations
United States, California
VA Medical Center, San Francisco
San Francisco, California, United States, 94121
Sponsors and Collaborators
Department of Veterans Affairs
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: March 6, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Cycloserine
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
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 June 18, 2013