Extinction of Fear Memories With Glucocorticoids in Veterans With PTSD (VA CORT)
This study is currently recruiting participants.
Verified April 2013 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01090180
First received: March 15, 2010
Last updated: April 16, 2013
Last verified: April 2013
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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:
- 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.
- The glucocorticoid reduction effects will be cumulative; that is, reduction will persist, and further post-reactivation glucocorticoid administration will further reduce symptoms
- 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
- 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.
- 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: | September 2013 |
| Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01090180
Contacts
| Contact: Jessica Link-Malcolm, PhD | (214) 857-1014 | |
| Contact: E. Ellen Morris, PhD | (214) 857-0263 |
Locations
| United States, Texas | |
| VA North Texas Health Care System, Dallas | Recruiting |
| Dallas, Texas, United States, 75216 | |
| Contact: Jessica Link-Malcolm, PhD 214-857-1014 | |
| Contact: Alina Suris, PhD (214) 857-0722 alina.suris@va.gov | |
| Principal Investigator: Alina Suris, PhD | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Alina 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: | April 16, 2013 |
| 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 May 16, 2013