Stress Disorder, Post TraumaticPhase 2/3NCT00356278
D-cycloserine and Virtual Reality Exposure to Treat Iraq War Veterans With PTSD
A Phase 2/3 study testing D-Cycloserine, Alprazolam and Virtual Reality Exposure Therapy in people with Stress Disorder, Post Traumatic, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Stress Disorder, Post Traumatic
- What is being tested?
- D-Cycloserine, Alprazolam and Virtual Reality Exposure Therapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Jun 2014
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets DSM-IV criteria for PTSD due to Iraq military trauma
- Speaks English
- Healthy overall
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cognitive Enhancer May Facilitate Behavioral Exposure Therapy for Veterans With PTSD
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.
Read the detailed description
Post-traumatic stress disorder (PTSD) is a type of anxiety disorder affecting people who have witnessed or experienced a traumatic event. Veterans of war are at an increased risk for developing PTSD because of their experiences with war and combat. Symptoms of PTSD often include flashbacks or nightmares, depression, anxiety or uneasiness, and feeling emotionally numb or distant toward others. Fortunately, PTSD can be treated, usually with some combination of anti-depressants, anti-anxiety medication, and therapy. Virtual reality exposure (VRE) therapy is a new type of treatment that helps people to overcome anxiety about trauma by facing situations with the use of virtual reality. D-cycloserine is a medication that has been found to enhance the effects of psychotherapy in recent studies. This study will determine the effectiveness of VRE therapy plus D-cycloserine at reducing PTSD symptoms in Iraq war veterans.
During this study, all participants will undergo one educational session and five VRE sessions. The first session will involve gathering information, learning common reactions to trauma, and participating in a breathing relaxation approach. The following five sessions will involve reviewing memories of Iraq and watching virtual Iraq sequences. Each participant will wear a head-mounted display during which they will view scenario settings such as cities, humvee convoys, and scenes related to combat. Participants will be randomly assigned to receive D-cycloserine, alprazolam (anti-anxiety drug), or placebo one half-hour before each VRE session.
Prior to the first treatment session, participants will undergo a startle reaction procedure. This will entail hearing sudden tones that last a fraction of a second, and viewing virtual reality scenes. Three small electrodes, attached to each participant's face, will measure the number of eye blinks during the procedure. At several times throughout the study, heart rate and skin conductance will also be measured with electrodes. Collection of saliva samples and measurement of blood pressure will also occur several times during this study. Before, during, and immediately after treatment, participants will complete questionnaires. Participants will be contacted 3, 6, and 12 months after treatment to assess symptoms and to schedule a time for an interview, additional questionnaires, and the virtual reality-based assessment.
- Conditions
- Stress Disorder, Post Traumatic
- Being tested
- D-Cycloserine, Alprazolam, Virtual Reality Exposure Therapy, Placebo
- Keywords
- D-Cycloserine, Virtual Reality, Exposure Therapy, Veterans, Cognitive Behavior Therapy, Translational Research
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
AlprazolamDrug
Also called Xanax
Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.
Virtual Reality Exposure TherapyBehavioural
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.
PlaceboDrug
Placebo will be administered in the same manner as the active drugs.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Participants will receive VRE therapy and D-cycloserine Receives: Drug: D-Cycloserine; Behavioral: Virtual Reality Exposure Therapy |
| B | Active comparator | Participants will receive VRE therapy and alprazolam Receives: Drug: Alprazolam; Behavioral: Virtual Reality Exposure Therapy |
| C | Placebo comparator | Participants will receive VRE therapy and placebo Receives: Behavioral: Virtual Reality Exposure Therapy; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 12
Secondary outcomes (5)
PTSD Symptom Scale Self-Report
PTSD Symptom Scale - Self-Report Version (PSS-SR) is a 17-item self-reported questionnaire to assess symptoms of PTSD. Each of the 17 items describe PTSD symptoms which respondents rate in terms of their frequency or severity using a Likert-type scale ranging from 0 (not at all or only one time) to 3 (almost always or five or more times per week). Ratings on items are summed to create three subscales, including re-experiencing, avoidance, and arousal, as well as a total score (that ranges from 0 to 51). The total score higher than 13 indicates on likelihood of PTSD.
Measured: Baseline
PTSD Symptom Scale Self-Report
PTSD Symptom Scale - Self-Report Version (PSS-SR) is a 17-item self-reported questionnaire to assess symptoms of PTSD. Each of the 17 items describe PTSD symptoms which respondents rate in terms of their frequency or severity using a Likert-type scale ranging from 0 (not at all or only one time) to 3 (almost always or five or more times per week). Ratings on items are summed to create three subscales, including re-experiencing, avoidance, and arousal, as well as a total score (that ranges from 0 to 51). The total score higher than 13 indicates on likelihood of PTSD.
Measured: Posttreatment, 8 weeks
PTSD Symptom Scale Self-Report
PTSD Symptom Scale - Self-Report Version (PSS-SR) is a 17-item self-reported questionnaire to assess symptoms of PTSD. Each of the 17 items describe PTSD symptoms which respondents rate in terms of their frequency or severity using a Likert-type scale ranging from 0 (not at all or only one time) to 3 (almost always or five or more times per week). Ratings on items are summed to create three subscales, including re-experiencing, avoidance, and arousal, as well as a total score (that ranges from 0 to 51). The total score higher than 13 indicates on likelihood of PTSD.
Measured: Month 3
PTSD Symptom Scale Self-Report
PTSD Symptom Scale - Self-Report Version (PSS-SR) is a 17-item self-reported questionnaire to assess symptoms of PTSD. Each of the 17 items describe PTSD symptoms which respondents rate in terms of their frequency or severity using a Likert-type scale ranging from 0 (not at all or only one time) to 3 (almost always or five or more times per week). Ratings on items are summed to create three subscales, including re-experiencing, avoidance, and arousal, as well as a total score (that ranges from 0 to 51). The total score higher than 13 indicates on likelihood of PTSD.
Measured: Month 6
PTSD Symptom Scale Self-Report
PTSD Symptom Scale - Self-Report Version (PSS-SR) is a 17-item self-reported questionnaire to assess symptoms of PTSD. Each of the 17 items describe PTSD symptoms which respondents rate in terms of their frequency or severity using a Likert-type scale ranging from 0 (not at all or only one time) to 3 (almost always or five or more times per week). Ratings on items are summed to create three subscales, including re-experiencing, avoidance, and arousal, as well as a total score (that ranges from 0 to 51). The total score higher than 13 indicates on likelihood of PTSD.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2006 (estimated)
- Study startSep 2006
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stress Disorder, Post TraumaticStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Barbara O. Rothbaum, PhD, Emory University
- Investigators
- Barbara O. Rothbaum, PhD, ABPP, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00356278
- Sponsor's protocol ID
- IRB00024846
- Other IDs
- DATR AD-TS, R01MH070880
- Status last verified
- Jan 2016
- First submitted
- 24 Jul 2006
- Last updated
- 8 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 30059794Norrholm 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.
PubMed 27183343Rothbaum 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.
PubMed 24743802
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cognitive Enhancer May Facilitate Behavioral Exposure Therapy for Veterans With PTSD
- ClinicalTrials.gov ID
- NCT00356278
- Acronym / sponsor ID
- IRB00024846
- Conditions
- Stress Disorder, Post Traumatic
- Keywords
- D-Cycloserine, Virtual Reality, Exposure Therapy, Veterans, Cognitive Behavior Therapy, Translational Research
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2006
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 25 Jul 2006 (estimated)
- Results
- Posted 19 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Post-traumatic stress disorder (PTSD) is a type of anxiety disorder affecting people who have witnessed or experienced a traumatic event. Veterans of war are at an increased risk for developing PTSD because of their experiences with war and combat. Symptoms of PTSD often include flashbacks or nightmares, depression, anxiety or uneasiness, and feeling emotionally numb or distant toward others. Fortunately, PTSD can be treated, usually with some combination of anti-depressants, anti-anxiety medication, and therapy. Virtual reality exposure (VRE) therapy is a new type of treatment that helps people to overcome anxiety about trauma by facing situations with the use of virtual reality. D-cycloserine is a medication that has been found to enhance the effects of psychotherapy in recent studies. This study will determine the effectiveness of VRE therapy plus D-cycloserine at reducing PTSD symptoms in Iraq war veterans.
During this study, all participants will undergo one educational session and five VRE sessions. The first session will involve gathering information, learning common reactions to trauma, and participating in a breathing relaxation approach. The following five sessions will involve reviewing memories of Iraq and watching virtual Iraq sequences. Each participant will wear a head-mounted display during which they will view scenario settings such as cities, humvee convoys, and scenes related to combat. Participants will be randomly assigned to receive D-cycloserine, alprazolam (anti-anxiety drug), or placebo one half-hour before each VRE session.
Prior to the first treatment session, participants will undergo a startle reaction procedure. This will entail hearing sudden tones that last a fraction of a second, and viewing virtual reality scenes. Three small electrodes, attached to each participant's face, will measure the number of eye blinks during the procedure. At several times throughout the study, heart rate and skin conductance will also be measured with electrodes. Collection of saliva samples and measurement of blood pressure will also occur several times during this study. Before, during, and immediately after treatment, participants will complete questionnaires. Participants will be contacted 3, 6, and 12 months after treatment to assess symptoms and to schedule a time for an interview, additional questionnaires, and the virtual reality-based assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: D-Cycloserine, Behavioral: Virtual Reality Exposure TherapyParticipants will receive VRE therapy and D-cycloserine |
| B | Active comparator | Drug: Alprazolam, Behavioral: Virtual Reality Exposure TherapyParticipants will receive VRE therapy and alprazolam |
| C | Placebo comparator | Behavioral: Virtual Reality Exposure Therapy, Drug: PlaceboParticipants will receive VRE therapy and placebo |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meets DSM-IV criteria for PTSD due to Iraq military trauma
- Speaks English
- Healthy overall
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-CycloserineD-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session. | Drug | A |
| AlprazolamAlso: XanaxAlprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session. | Drug | B |
| Virtual Reality Exposure TherapyVRE 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. | Behavioural | A, B, C |
| PlaceboPlacebo will be administered in the same manner as the active drugs. | Drug | C |
Primary outcome
Clinician-Administered PTSD Scale (CAPS)
Time frame: Baseline
Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.
Clinician-Administered PTSD Scale (CAPS)
Time frame: Posttreatment, 8 weeks
Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.
Clinician-Administered PTSD Scale (CAPS)
Time frame: Month 3
Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.
Clinician-Administered PTSD Scale (CAPS)
Time frame: Month 6
Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.
Clinician-Administered PTSD Scale (CAPS)
Time frame: Month 12
Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.
5 secondary outcomes
PTSD Symptom Scale Self-Report
Time frame: Baseline
PTSD Symptom Scale Self-Report
Time frame: Posttreatment, 8 weeks
PTSD Symptom Scale Self-Report
Time frame: Month 3
PTSD Symptom Scale Self-Report
Time frame: Month 6
PTSD Symptom Scale Self-Report
Time frame: Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30059794Rauch 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.
- Derived from this study: PubMed 27183343Norrholm 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.
- Derived from this study: PubMed 24743802Rothbaum 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara O. Rothbaum, PhD, ABPP principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing D-Cycloserine, Alprazolam and Virtual Reality Exposure Therapy in people with Stress Disorder, Post Traumatic, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician-Administered PTSD Scale (CAPS) (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00356278, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2016.