Extinction of Fear Memories With Glucocorticoids in Veterans With PTSD (VA CORT)
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.
|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|
- 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, 1 month, 3 months, and 6 months follow up. ] [ Designated as safety issue: No ]The PCL is a 17-item measure of PTSD symptom severity with a range from 17-85. Each item is rated from 1-5 with higher scores are indicative of higher symptom severity. Scores of the 17 items are summed in order to generate the total score.
- Quick Inventory of Depressive Symptomatology- Self Report (QIDS-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, 1 month, 3 months, and 6 months follow up. ] [ Designated as safety issue: No ]The QIDS-SR is a 16-item measure of depression symptom severity with a range from 0-27. Each item is rated from 0-3 with higher scores are indicative of higher symptom severity. Scores of the items are aggregated (with the highest score on overlapping items chosen; e.g., sleep disturbances, changes in eating) to generate the total score..
|Study Start Date:||April 2010|
|Study Completion Date:||September 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: Arm 1: 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
Drug: Placebo (sugar pill)
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01090180
|United States, Texas|
|VA North Texas Health Care System, Dallas|
|Dallas, Texas, United States, 75216|
|Principal Investigator:||Alina M Suris, PhD||VA North Texas Health Care System, Dallas|