Extinction of Fear Memories With Glucocorticoids in Veterans With PTSD (VA CORT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01090180
First received: March 15, 2010
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to examine the effects of glucocorticoid administration following traumatic memory reactivation on psychiatric symptoms in veterans with combat-related PTSD, in addition to examining the effects of glucocorticoid administration following traumatic memory reactivation on physiological responses to veteran's personal combat memories. The following hypotheses will be tested:

  1. Subjects who receive an exogenous glucocorticoid after traumatic memory reactivation will demonstrate fewer PTSD and depression symptoms one week later, compared to those who receive a placebo after traumatic memory reactivation.
  2. The glucocorticoid reduction effects will be cumulative; that is, reduction will persist, and further post-reactivation glucocorticoid administration will further reduce symptoms
  3. Decreases in PTSD and depression symptoms will persist at 1, 3, and 6 months for subjects receiving an exogenous glucocorticoid compared to those subjects receiving placebo
  4. Subjects who receive an exogenous glucocorticoid after traumatic memory reactivation will demonstrate decreased physiological responses one week later, compared to those who receive a placebo after traumatic memory reactivation.
  5. As with the psychological measures, suppression of the physiological measures will demonstrate both persistence over time and accumulation with subsequent post-reactivation glucocorticoid administration.

Condition Intervention
Posttraumatic Stress Disorder
Drug: Dexamethasone
Drug: Placebo (sugar pill)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Extinction of Fear Memories With Glucocorticoids in Veterans With PTSD

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Psychophysiological Measures (Skin Conductance, Heart rate, electromyograph of frontalis muscle, electromyograph of corrugator muscle. We expect to see a decrease in all these psychophysiological measures from week to week after each memory activation. [ Time Frame: 7 days after the first administration of study medication, and then 60 minutes after receiving study medication for 3 consecutive weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinician Administered PTSD Scale (CAPS). This will be used to measure PTSD symptoms in the past month. It is recognized as the gold standard of PTSD assessment in the field. [ Time Frame: This measure will be administered at the baseline assessment session (before treatment), as well as 1 month, 3 months and 6 months after treatment concludes. ] [ Designated as safety issue: No ]
  • Quick Inventory of Depressive Symptomatology- Self Report (QUIDS-SR). Because depression can be comorbid with PTSD (70% comorbidity found in pilot sample), this assessment will be used to measure depressive symptoms over a 1 week timeframe [ Time Frame: This measure will be administered at all study visits: Baseline, Treatment sessions 1-4, 1 month, 3 months, and 6 months follow up. ] [ Designated as safety issue: No ]
  • PTSD Checklist (PCL). A self-report, face valid measure of PTSD symptoms over a 1 week time period [ Time Frame: This measure will be administered at all study visits: Baseline, Treatment sessions 1-4, 1 month, 3 months, and 6 months follow up. ] [ Designated as safety issue: No ]

Estimated Enrollment: 102
Study Start Date: April 2010
Estimated Study Completion Date: December 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Dexamethasone (oral)
Drug: Dexamethasone
anti-inflammatory adrenocortical steroid The following dose schedule will be given: 0.15mg/kg (based on body weight) every 7 days for 4 consecutive weeks
Placebo Comparator: Arm 2
Placebo (inactive)
Drug: Placebo (sugar pill)
inactive

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male veterans enrolled to receive care through the VA North Texas Healthcare System
  • diagnosis of combat-related PTSD

Exclusion Criteria:

  • Hypersensitivity to dexamethasone
  • Current use of steroids
  • Current psychosis
  • Organic Brain Damage
  • Current major depressive disorder with melancholic features
  • Substance dependence in the last 3 months
  • Prominent suicidal or homicidal features
  • Medical conditions: diabetes, uncontrolled hypertension, severe congestive heart failure, hepatic failure, or any other contraindicated medical condition (such as HPA Axis disease, Addison's Disease or Cushing's Disease).
  • Veterans taking medication with established drug interactions with dexamethasone
  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: NCT01090180

Locations
United States, Texas
VA North Texas Health Care System, Dallas
Dallas, Texas, United States, 75216
Sponsors and Collaborators
Investigators
Principal Investigator: Alina M Suris, PhD VA North Texas Health Care System, Dallas
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01090180     History of Changes
Other Study ID Numbers: D6902-R, 09-052
Study First Received: March 15, 2010
Last Updated: June 23, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
PTSD
combat
stress disorders
veteran

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Glucocorticoids
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2014