N/A
N=62
Extinction of Fear Memories With Glucocorticoids in Veterans With PTSD
Posttraumatic Stress Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01090180 ↗Enrolled (actual)
62
Serious AEs
1.6%
Results posted
Nov 2016
Primary outcome: Primary: PTSD Checklist (PCL). A Self-report, Face Valid Measure of PTSD Symptoms Over a 1 Week Time Period — 55.76; 54.83; 50.14; 51.57 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dexamethasone (Drug); Placebo (sugar pill) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PTSD Checklist (PCL). A Self-report, Face Valid Measure of PTSD Symptoms Over a 1 Week Time Period |
55.76; 54.83; 50.14; 51.57; 45.45; 51.89 | — |
| SECONDARY 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 |
13.55; 12.86; 10.68; 10.71; 11.38; 11.32 | — |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01090180). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.