Extinction of Fear Memories With Glucocorticoids in Veterans With PTSD

NCT01090180 | Completed Results DMC

• 2 other identifiers: D6902-R09-052
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.The glucocorticoid reduction effects will be cumulative; that is, reduction will persist, and further post-reactivation glucocorticoid administration will further reduce symptoms
3. 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. 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. 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.

Conditions

Posttraumatic Stress Disorder

Keywords

PTSD; combat; stress disorders; veteran

Outcome Measures

Primary Outcomes (1)

• PTSD Checklist (PCL). A Self-report, Face Valid Measure of PTSD Symptoms Over a 1 Week Time Period

  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.

  This measure will be administered at all study visits: Baseline, 1 month, 3 months, and 6 months follow up.

Secondary Outcomes (1)

• 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

  This measure will be administered at all study visits: Baseline, 1 month, 3 months, and 6 months follow up.

Study Arms (2)

Arm 1: Dexamethasone

EXPERIMENTAL

Dexamethasone (oral)

Drug: Dexamethasone

Arm 2: Placebo

PLACEBO COMPARATOR

Placebo (inactive)

Drug: Placebo (sugar pill)

Interventions

Dexamethasone DRUG

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

Arm 1: Dexamethasone

Placebo (sugar pill) DRUG

inactive

Arm 2: Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA North Texas Health Care System, Dallas

Dallas, Texas, 75216, United States

Location

Related Publications (1)

• Suris A, Holliday R, Adinoff B, Holder N, North CS. Facilitating Fear-Based Memory Extinction With Dexamethasone: A Randomized Controlled Trial in Male Veterans With Combat-Related PTSD. Psychiatry. 2017 Winter;80(4):399-410. doi: 10.1080/00332747.2017.1286892.

  PMID: 29466111 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Stress Disorders, Traumatic

Interventions

Dexamethasone; Sugars

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Carbohydrates

Results Point of Contact

• Title: Alina Suris
• Organization: Veterans Affairs North Texas Health Care System

alina.suris@va.gov

817-715-0625

Study Officials

• Alina M Suris, PhD

  VA North Texas Health Care System, Dallas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2010
• First Posted: March 19, 2010
• Study Start: April 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: November 25, 2016
• Results First Posted: November 25, 2016

Record last verified: 2016-10

Locations

US (1)