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

This study is not yet open for participant recruitment.

Verified by San Francisco Veterans Administration Medical Center, May 2008

Sponsored by:	San Francisco Veterans Administration Medical Center
Information provided by:	San Francisco Veterans Administration Medical Center
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

MedlinePlus related topics: Post-Traumatic Stress Disorder

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment
Official Title:	Effects of Hydrocortisone and D-Cycloserine on Fear Extinction in Veterans With Posttraumatic Stress Disorder

Further study details as provided by San Francisco Veterans Administration Medical Center:

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:	84
Study Start Date:	July 2008
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male veterans with an age range of 18 to 65 years
Participants must be healthy male volunteers
Veterans must meet DSM-IV criteria for full current PTSD or subsyndromal PTSD (as indexed by the CAPS criteria or with a CAPS score > 40 and meeting 2 of 3 of B, C, and D symptom clusters) of at least 3 months duration related to war trauma

Exclusion Criteria:

Active suicidal intention, schizophrenia, schizoaffective disorder, alcohol or substance abuse or dependence within the past 3 months, bipolar disorder, or seizure disorders
Neurological disorder, head injury (e.g., loss of consciousness greater than 10 minutes), systemic illness affecting CNS function, or medically unstable injuries
Psychotropic medications, including antidepressants, 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

Contacts

Contact: Sabra S Inslicht, Ph.D.

415-221-4810 ext 3341

sabra.inslicht@va.gov

Locations

United States, California
San Francisco VA Medical Center
San Francisco, California, United States, 94121

Sponsors and Collaborators

San Francisco Veterans Administration Medical Center

Investigators

Principal Investigator:

Sabra S Inslicht, Ph.D.

San Francisco VA Medical Center

More Information

Responsible Party:	San Francisco Veterans Adminstration Medical Center ( Sabra S. Inslicht, Ph.D. )
Study ID Numbers:	H841-31915-01A
Study First Received:	May 6, 2008
Last Updated:	May 6, 2008
ClinicalTrials.gov Identifier:	NCT00674570
Health Authority:	United States: Federal Government; United States: Institutional Review Board

Keywords provided by San Francisco Veterans Administration Medical Center:

Stress Disorders, Posttraumatic
Hydrocortisone
Cycloserine
Extinction,Psychological

Study placed in the following topic categories:

Cycloserine
Hydrocortisone
Cortisol succinate
Anxiety Disorders
Mental Disorders

Stress Disorders, Post-Traumatic
Stress
Hydrocortisone acetate
Stress Disorders, Traumatic

Additional relevant MeSH terms:

Antimetabolites
Anti-Inflammatory Agents
Anti-Infective Agents
Disease
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

Pharmacologic Actions
Antibiotics, Antitubercular
Anti-Bacterial Agents
Pathologic Processes
Therapeutic Uses
Antitubercular Agents

ClinicalTrials.gov processed this record on January 16, 2009