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

Tracking Information

First Received Date ^ICMJE

May 6, 2008

Last Updated Date

March 6, 2013

Start Date ^ICMJE

July 2008

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00674570 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science

Condition ^ICMJE

Stress Disorders, Posttraumatic

Intervention ^ICMJE

Drug: Hydrocortisone
25 mg/oral one hour prior to extinction task
Drug: D-Cycloserine
50 mg/oral one hour prior to extinction task
Drug: Placebo
One hour prior to extinction task

Study Arm (s)

Experimental: Arm 1
Hydrocortisone

Intervention: Drug: Hydrocortisone
Experimental: Arm 2
D-Cycloserine

Intervention: Drug: D-Cycloserine
Placebo Comparator: Arm 3
Placebo

Intervention: Drug: Placebo

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

July 2013

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00674570

Other Study ID Numbers ^ICMJE

H841-31915-01A

Has Data Monitoring Committee

Responsible Party

Department of Veterans Affairs

Study Sponsor ^ICMJE

Department of Veterans Affairs

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Sabra S. Inslicht, PhD

VA Medical Center, San Francisco

Information Provided By

Department of Veterans Affairs

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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