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

Sponsor:	Department of Veterans Affairs
Information provided by (Responsible Party):	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00674570

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:

MedlinePlus related topics: Post-Traumatic Stress Disorder

Drug Information available for: Hydrocortisone acetate Hydrocortisone Cycloserine Proctofoam-HC Hydrocortisone hemisuccinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone cypionate Cortisol succinate Cortisol 21-phosphate

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: 1 Hydrocortisone	Drug: Hydrocortisone 25 mg/oral one hour prior to extinction task
Experimental: 2 D-Cycloserine	Drug: D-Cycloserine 50 mg/oral one hour prior to extinction task
Placebo Comparator: 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

No publications provided

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:	October 21, 2011
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
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

ClinicalTrials.gov processed this record on February 09, 2012