Extinction of Fear Memories With Glucocorticoids in Veterans With PTSD (VA CORT)
|ClinicalTrials.gov Identifier: NCT01090180|
Recruitment Status : Completed
First Posted : March 19, 2010
Results First Posted : November 25, 2016
Last Update Posted : November 25, 2016
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 or disease||Intervention/treatment|
|Posttraumatic Stress Disorder||Drug: Dexamethasone Drug: Placebo (sugar pill)|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||129 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Extinction of Fear Memories With Glucocorticoids in Veterans With PTSD|
|Study Start Date :||April 2010|
|Primary Completion Date :||September 2013|
|Study Completion Date :||September 2013|
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)
- 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. ]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. ]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..
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|