NCT00356278

Brief Summary

This study will determine whether a combination of virtual reality exposure therapy and D-cycloserine will reduce post-traumatic stress disorder symptoms in Iraq war veterans.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2006

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 25, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
6 months until next milestone

Results Posted

Study results publicly available

November 19, 2014

Completed
Last Updated

January 8, 2016

Status Verified

January 1, 2016

Enrollment Period

7.8 years

First QC Date

July 24, 2006

Results QC Date

November 7, 2014

Last Update Submit

January 6, 2016

Conditions

Stress Disorder, Post Traumatic

Keywords

D-CycloserineVirtual RealityExposure TherapyVeteransCognitive Behavior TherapyTranslational Research

Outcome Measures

Primary Outcomes (5)

  • Clinician-Administered PTSD Scale (CAPS)

    Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.

    Baseline

  • Clinician-Administered PTSD Scale (CAPS)

    Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.

    Posttreatment, 8 weeks

  • Clinician-Administered PTSD Scale (CAPS)

    Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.

    Month 3

  • Clinician-Administered PTSD Scale (CAPS)

    Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.

    Month 6

  • Clinician-Administered PTSD Scale (CAPS)

    Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.

    Month 12

Secondary Outcomes (5)

  • PTSD Symptom Scale Self-Report

    Baseline

  • PTSD Symptom Scale Self-Report

    Posttreatment, 8 weeks

  • PTSD Symptom Scale Self-Report

    Month 3

  • PTSD Symptom Scale Self-Report

    Month 6

  • PTSD Symptom Scale Self-Report

    Month 12

Study Arms (3)

A

EXPERIMENTAL

Participants will receive VRE therapy and D-cycloserine

Drug: D-CycloserineBehavioral: Virtual Reality Exposure Therapy

B

ACTIVE COMPARATOR

Participants will receive VRE therapy and alprazolam

Drug: AlprazolamBehavioral: Virtual Reality Exposure Therapy

C

PLACEBO COMPARATOR

Participants will receive VRE therapy and placebo

Behavioral: Virtual Reality Exposure TherapyDrug: Placebo

Interventions

D-CycloserineDRUG

D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.

A
AlprazolamDRUG

Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.

Also known as: Xanax
B
Virtual Reality Exposure TherapyBEHAVIORAL

VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.

ABC
PlaceboDRUG

Placebo will be administered in the same manner as the active drugs.

C

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meets DSM-IV criteria for PTSD due to Iraq military trauma
  • Speaks English
  • Healthy overall

You may not qualify if:

  • History of mania, schizophrenia, or other psychoses
  • Suicidal
  • Current alcohol or drug dependence
  • Medication free within 2 weeks of study entry for any medication that has been taken less than daily for the past month and medicine free within 4 weeks of study entry for any anxiolytic medication that has been taken daily for the last month or more
  • Pregnant
  • Special medical conditions, such as kidney insufficiency, chronic diseases, or history of significant head injury
  • Stabilized on potentially data obscuring medication such as glucocorticoids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University

Atlanta, Georgia, 30329, United States

Location

Related Publications (3)

  • Rauch SAM, Koola C, Post L, Yasinski C, Norrholm SD, Black K, Rothbaum BO. In session extinction and outcome in Virtual Reality Exposure Therapy for PTSD. Behav Res Ther. 2018 Oct;109:1-9. doi: 10.1016/j.brat.2018.07.003. Epub 2018 Jul 20.

    PMID: 30059794DERIVED

  • Norrholm SD, Jovanovic T, Gerardi M, Breazeale KG, Price M, Davis M, Duncan E, Ressler KJ, Bradley B, Rizzo A, Tuerk PW, Rothbaum BO. Baseline psychophysiological and cortisol reactivity as a predictor of PTSD treatment outcome in virtual reality exposure therapy. Behav Res Ther. 2016 Jul;82:28-37. doi: 10.1016/j.brat.2016.05.002. Epub 2016 May 7.

    PMID: 27183343DERIVED

  • Rothbaum BO, Price M, Jovanovic T, Norrholm SD, Gerardi M, Dunlop B, Davis M, Bradley B, Duncan EJ, Rizzo A, Ressler KJ. A randomized, double-blind evaluation of D-cycloserine or alprazolam combined with virtual reality exposure therapy for posttraumatic stress disorder in Iraq and Afghanistan War veterans. Am J Psychiatry. 2014 Jun;171(6):640-8. doi: 10.1176/appi.ajp.2014.13121625.

    PMID: 24743802DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

CycloserineAlprazolamVirtual Reality Exposure Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

IsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsOxazolidinonesOxazolesSerineAmino Acids, NeutralAmino AcidsAmino Acids, Peptides, and ProteinsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDesensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Limitations and Caveats

The study had a high dropout rate. 31 participants dropped out before the first treatment session. Although disheartening, the dropout rate is similar to rates in other studies with veterans and active duty personnel.

Results Point of Contact

Title
Barbara O. Rothbaum, PhD, ABPP
Organization
Emory University
brothba@emory.edu
404-712-8866

Study Officials

  • Barbara O. Rothbaum, PhD, ABPP

    Emory University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Psychiatry and Associate Vice Chair of Clinical Research

Study Record Dates

First Submitted

July 24, 2006

First Posted

July 25, 2006

Study Start

September 1, 2006

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

January 8, 2016

Results First Posted

November 19, 2014

Record last verified: 2016-01

Locations

US(1)