Posttraumatic Stress DisorderVR-DCSNCT00632632
Virtual Reality & D-cycloserine (DCS) for Posttraumatic Stress Disorder (PTSD)
A study testing D-Cycloserine in people with Posttraumatic Stress Disorder, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
This study proposes to evaluate the effects of D-cycloserine (DCS) combined with Virtual Reality exposure therapy in a sample of patients who developed posttraumatic stress disorder (PTSD) following either the events of September 11, 2001, or military service in the war in Iraq. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- D-Cycloserine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Dec 2012
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking adults
- Between the ages of 18 and 70
- Exposed to the WTC Attacks (were in towers or in the immediate area) or veterans of the Iraq War
- Diagnosed with PTSD symptoms.
Who cannot join
- Presence of current organic mental disorder
- Schizophrenia
- Bipolar disorder
- Depression with psychotic features
- Current substance dependence
- Delusional disorder
Show all 15Show fewer
- Active suicidal ideation, intent, or plan
- Active homicidal ideation, intent, or plan
- Use of pacemaker
- Medically unstable
- Pregnant or lactating
- A history of severe renal disease
- History of seizures
- Currently taking anticoagulants, ethionamide (Trecator-SC) or isoniazid (INH)
- History of allergic reaction to cycloserine.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10065
About this study
Official title: Combined Exposure Therapy and D-Cycloserine vs. Placebo for Posttraumatic Stress Disorder
This study proposes to evaluate the effects of D-cycloserine (DCS) combined with Virtual Reality exposure therapy in a sample of patients who developed posttraumatic stress disorder (PTSD) following either the events of September 11, 2001, or military service in the war in Iraq. In addition, this study hopes to determine whether a common human genetic single nucleotide polymorphism (SNP) in a growth factor, brain derived neurotrophic factor, BDNF (Val66Met), predicts treatment response to PTSD.
Overall, this study aims 1) to determine if subjects administered DCS show a significantly larger decrease in symptoms of PTSD as compared to those administered a placebo, 2) to determine if subjects administered DCS show a decrease in PTSD symptomatology significantly earlier (as measured by weeks) than those administered a placebo, 3) to determine if differences in symptomatology are evident at a 6-month follow-up and indicate long-term differences between groups, and 4) to determine if the BDNF SNP predicts treatment response.
Read the detailed description
Participants with 9/11-related or military service in the Iraq War-related PTSD are assigned to one of two programs, following an initial assessment. Both programs include Virtual Reality Exposure Therapy (VRET) for the treatment of PTSD as well as widely-used standard cognitive-behavioral therapy techniques. The VRET is comprised of ten ninety minute sessions which involve mental imagery as well as virtual reality presentations delivered by a special display worn over the head and eyes. The virtual reality simulations consist of either images of the World Trade Center and the events of September 11, 2001 or multiple scenarios common to military personnel assigned to Iraq. One group of participants will receive the medication cycloserine (seromycin) and one group will receive a placebo drug (like a sugar pill). Participants take a dose of medication only on the days that they come to the laboratory for the Virtual Reality Exposure (VRE) sessions, and 90 minutes prior to the VRE sessions. Some subjects in the study will receive a 100 mg dose of cycloserine, and other subjects in the study will receive the placebo (sugar pill). This will be determined randomly (as by the flip of a coin). Neither the patient nor the treating clinicians will know which pill that patients are receiving; however, this arrangement may be changed if medically necessary. Patients are briefly assessed for well-being at every session, and are reassessed following session three, session six, and session ten for changes in symptomatology. At the completion of treatment and again six months later, the principal investigator or one of her associates will reinterview participants and have them complete some questionnaires.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- D-Cycloserine, Placebo
- Keywords
- World Trade Center Victims, Iraq War Veterans, PTSD
- 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
Cognitive behavioral treatment (CBT) including prolonged exposure enhanced by virtual reality with D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
PlaceboOther
Cognitive behavioral treatment (CBT) including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (approximately 10-12 times).
| Study group | Role | What they receive |
|---|---|---|
| D-Cycloserine (DCS) | Experimental | Not described Receives: Drug: D-Cycloserine |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered PTSD Scale(CAPS)
Total CAPS severity score range is 0-136. Higher values represent a worse outcome (i.e. greater severity of posttraumatic symptoms). CAPS consists of 3 subscales, which are combined to form a total severity score.
Subscales:
CAPS cluster B (reexperiencing symptoms, range 0-40) CAPS cluster C (avoidance and numbing symptoms, range 0-56) CAPS cluster D (hyperarousal symptoms, range 0-40)
Measured: Immediately following treatment
Clinician Administered PTSD Scale(CAPS)
Total CAPS severity score range is 0-136. Higher values represent a worse outcome (i.e. greater severity of posttraumatic symptoms). CAPS consists of 3 subscales, which are combined to form a total severity score.
Subscales:
CAPS cluster B (reexperiencing symptoms, range 0-40) CAPS cluster C (avoidance and numbing symptoms, range 0-56) CAPS cluster D (hyperarousal symptoms, range 0-40)
Measured: 6-months follow-up
Secondary outcomes (1)
Structured Clinical Interview for DSM-IV - Major Depressive Disorder (SCID-MDD)
Structured Clinical Interview for DSM-IV - Major Depressive Disorder is a clinical interview to assess presence/absence of Major Depressive Disorder.
Measured: Immediately following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2008 (estimated)
- Study startJan 2005
- Primary completionDec 2012
- Study completionDec 2012
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.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JoAnn Difede, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00632632
- Sponsor's protocol ID
- 0411007625
- Acronym
- VR-DCS
- Status last verified
- Jul 2015
- First submitted
- 29 Feb 2008
- Last updated
- 27 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Exposure Therapy and D-Cycloserine vs. Placebo for Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT00632632
- Acronym / sponsor ID
- VR-DCS / 0411007625
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- World Trade Center Victims, Iraq War Veterans, PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 11 Mar 2008 (estimated)
- Results
- Posted 27 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study proposes to evaluate the effects of D-cycloserine (DCS) combined with Virtual Reality exposure therapy in a sample of patients who developed posttraumatic stress disorder (PTSD) following either the events of September 11, 2001, or military service in the war in Iraq. In addition, this study hopes to determine whether a common human genetic single nucleotide polymorphism (SNP) in a growth factor, brain derived neurotrophic factor, BDNF (Val66Met), predicts treatment response to PTSD.
Overall, this study aims 1) to determine if subjects administered DCS show a significantly larger decrease in symptoms of PTSD as compared to those administered a placebo, 2) to determine if subjects administered DCS show a decrease in PTSD symptomatology significantly earlier (as measured by weeks) than those administered a placebo, 3) to determine if differences in symptomatology are evident at a 6-month follow-up and indicate long-term differences between groups, and 4) to determine if the BDNF SNP predicts treatment response.
Detailed description
Participants with 9/11-related or military service in the Iraq War-related PTSD are assigned to one of two programs, following an initial assessment. Both programs include Virtual Reality Exposure Therapy (VRET) for the treatment of PTSD as well as widely-used standard cognitive-behavioral therapy techniques. The VRET is comprised of ten ninety minute sessions which involve mental imagery as well as virtual reality presentations delivered by a special display worn over the head and eyes. The virtual reality simulations consist of either images of the World Trade Center and the events of September 11, 2001 or multiple scenarios common to military personnel assigned to Iraq. One group of participants will receive the medication cycloserine (seromycin) and one group will receive a placebo drug (like a sugar pill). Participants take a dose of medication only on the days that they come to the laboratory for the Virtual Reality Exposure (VRE) sessions, and 90 minutes prior to the VRE sessions. Some subjects in the study will receive a 100 mg dose of cycloserine, and other subjects in the study will receive the placebo (sugar pill). This will be determined randomly (as by the flip of a coin). Neither the patient nor the treating clinicians will know which pill that patients are receiving; however, this arrangement may be changed if medically necessary. Patients are briefly assessed for well-being at every session, and are reassessed following session three, session six, and session ten for changes in symptomatology. At the completion of treatment and again six months later, the principal investigator or one of her associates will reinterview participants and have them complete some questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D-Cycloserine (DCS) | Experimental | Drug: D-Cycloserine |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English-speaking adults
- Between the ages of 18 and 70
- Exposed to the WTC Attacks (were in towers or in the immediate area) or veterans of the Iraq War
- Diagnosed with PTSD symptoms.
Key exclusion criteria (15 listed)
- Presence of current organic mental disorder
- Schizophrenia
- Bipolar disorder
- Depression with psychotic features
- Current substance dependence
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-CycloserineCognitive behavioral treatment (CBT) including prolonged exposure enhanced by virtual reality with D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times) | Drug | D-Cycloserine (DCS) |
| PlaceboCognitive behavioral treatment (CBT) including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (approximately 10-12 times). | Other | Placebo |
Primary outcome
Clinician Administered PTSD Scale(CAPS)
Time frame: Immediately following treatment
Total CAPS severity score range is 0-136. Higher values represent a worse outcome (i.e. greater severity of posttraumatic symptoms). CAPS consists of 3 subscales, which are combined to form a total severity score. Subscales: CAPS cluster B (reexperiencing symptoms, range 0-40) CAPS cluster C (avoidance and numbing symptoms, range 0-56) CAPS cluster D (hyperarousal symptoms, range 0-40)
Clinician Administered PTSD Scale(CAPS)
Time frame: 6-months follow-up
Total CAPS severity score range is 0-136. Higher values represent a worse outcome (i.e. greater severity of posttraumatic symptoms). CAPS consists of 3 subscales, which are combined to form a total severity score. Subscales: CAPS cluster B (reexperiencing symptoms, range 0-40) CAPS cluster C (avoidance and numbing symptoms, range 0-56) CAPS cluster D (hyperarousal symptoms, range 0-40)
1 secondary outcome
Structured Clinical Interview for DSM-IV - Major Depressive Disorder (SCID-MDD)
Time frame: Immediately following treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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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.
JoAnn Difede, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D-Cycloserine in people with Posttraumatic Stress Disorder, run by Weill Medical College of Cornell 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 4 inclusion and 15 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 27 Aug 2015. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Aug 2015). 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: Immediately following treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2015.