Post-Traumatic Stress DisordersNCT00641173
Early Intervention for Post Traumatic Stress Disorder (PTSD)
A study testing paroxetine in people with Post-Traumatic Stress Disorders, run by US Department of Veterans Affairs.
Trial summary
Over 150,000 soldiers are currently deployed in Iraq as part of Operation Iraqi Freedom (OIF), and 12% of returning OIF veterans have posttraumatic stress disorder (PTSD). Intervening soon after the trauma is critical for long-term outcomes, since with time traumatic memories become resistant to treatment. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Post-Traumatic Stress Disorders
- What is being tested?
- paroxetine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female veterans age 18-50
- Returned from Iraq Theater within the past six months
- Screen positive for PTSD related to Iraq deployment based on the PTSD Checklist
- Confirmed with PTSD based on the CAPS, including one month duration of symptoms
- Being discharged from active service from Iraq
- Provide written informed consent
Who cannot join
- History of loss of consciousness of more than one minute
- Psychotropic medication use within the previous four weeks
- History (based on the SCID) of lifetime or current alcohol or substance abuse/dependence, schizophrenia, schizoaffective disorder, or bipolar disorder.
- Positive urine toxicology screen
- History of pre-deployment-related PTSD or partial PTSD based on the CAPS
- History of PTSD or partial PTSD related to a prior deployment
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- Serious medical or neurological illness
- Pregnancy
- History of asthma
- Steroid usage, both inhaled and oral
- Seizure disorder
- Prenatal/perinatal substance exposure or trauma.
About this study
Official title: Early Intervention for PTSD in Iraqi Veterans
Over 150,000 soldiers are currently deployed in Iraq as part of Operation Iraqi Freedom (OIF), and 12% of returning OIF veterans have posttraumatic stress disorder (PTSD). Intervening soon after the trauma is critical for long-term outcomes, since with time traumatic memories become resistant to treatment. The current study will compare treatment with the selective serotonin reuptake inhibitor (SSRI) paroxetine to placebo in returning OIF veterans who have returned from Iraq in the past six months, who meet criteria for early PTSD. Assessment of PTSD symptoms, brain markers, neuropsychological testing of memory, and cortisol response to an Iraq-related traumatic script before and after the intervention are proposed to provide information about the effects of the interventions on PTSD symptoms and stress-responsive hormonal systems.
Read the detailed description
Over 150,000 soldiers are currently deployed in Iraq as part of Operation Iraqi Freedom (OIF), and 12% of returning OIF veterans have posttraumatic stress disorder (PTSD). 389,100 soldiers developed chronic PTSD from the Vietnam War, requiring a life-time of VA mental health care. These veterans have suffered from a loss of work productivity, but also show greater utilization of health care resources and higher rates of physical disease. Research from our group and others showed lasting neurobiological consequences of PTSD, including an increased cortisol response to traumatic reminders, verbal declarative memory problems,6 and smaller hippocampal volume that reverses with treatment with the serotonin reuptake inhibitor (SSRI) paroxetine or the anticonvulsant phenytoin. Recently we found that three months of treatment with paroxetine in PTSD patients resulted in an increase in hippocampal N-acetyl-aspartate (NAA), a marker of neuronal integrity. Subjects treated with placebo did not have an increase in NAA, however subsequent treatment for three months with open label paroxetine resulted in an increase in NAA to the level seen in the subjects treated with paroxetine in the double-blind phase. Intervening soon after the trauma is critical for long-term outcomes, since with time traumatic memories become indelible and resistant to treatment. Diminished efficacy of treatment over time is shown by the fact that trials of Vietnam veterans have shown less efficacy over the years. Animal studies show that pretreatment before stress with antidepressants reduces chronic behavioral deficits related to stress; although for ethical and other reasons no studies have provided pretreatment before trauma exposure in humans. No studies have looked at the ability of antidepressants to treat early PTSD, which we are seeing in great numbers in veterans returning from OIF. This is important, since medications are not without side effects, and we cannot assume that early PTSD in Iraq veterans is the same as, for example, chronic Vietnam-related PTSD. Obtaining information about the risks and benefits of early treatment of PTSD in OIF veterans is critical to guiding treatment approaches to this emerging population. In addition, little is known about potential biomarkers of treatment response. We are working with the Georgia National Guard 48th Combat Brigade to evaluate the health needs of returning OIF veterans, and have started an OIF/OEF Trauma Clinic at the Atlanta VAMC where the PI is screening returning OIF veterans. We now propose to compare paroxetine and to placebo in returning OIF veterans who have returned from Iraq in the past six months, who meet criteria for early PTSD. Assessment of PTSD symptoms, hippocampal volume and NAA, neuropsychological testing of memory, and cortisol response to an Iraq-related traumatic script before and after the intervention are proposed to provide information about the effects of the interventions on PTSD symptoms and stress-responsive hormonal systems.
- Conditions
- Post-Traumatic Stress Disorders
- Being tested
- paroxetine, placebo
- Keywords
- PTSD, cortisol, hippocampus, memory
- 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.
paroxetineDrug
treatment with SSRI paroxetine
placeboDrug
treatment with placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | paroxetine v placebo Receives: Drug: paroxetine |
| 2 | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
CAPS
Measured: three months
Secondary outcomes (3)
hippocampal volume and NAA
Measured: three months
memory
Measured: three months
cortisol response to stress
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startSep 2008
- Primary completionApr 2011
- Study completionApr 2011
Why it stopped: Withdrawn by funding source
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress DisordersStudies of the same condition, open and under way.
- 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
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- Emory University
- Investigators
- Doug Bremner, MD, Principal investigator, Atlanta VA Medical and Rehab Center, Decatur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00641173
- Sponsor's protocol ID
- MHBA-009-06F
- Status last verified
- Jun 2015
- First submitted
- 17 Mar 2008
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intervention for PTSD in Iraqi Veterans
- ClinicalTrials.gov ID
- NCT00641173
- Acronym / sponsor ID
- MHBA-009-06F
- Conditions
- Post-Traumatic Stress Disorders
- Keywords
- PTSD, cortisol, hippocampus, memory
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn by funding source
- Enrolment
- 0 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- Emory University
- Study start
- Sep 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 24 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Over 150,000 soldiers are currently deployed in Iraq as part of Operation Iraqi Freedom (OIF), and 12% of returning OIF veterans have posttraumatic stress disorder (PTSD). Intervening soon after the trauma is critical for long-term outcomes, since with time traumatic memories become resistant to treatment. The current study will compare treatment with the selective serotonin reuptake inhibitor (SSRI) paroxetine to placebo in returning OIF veterans who have returned from Iraq in the past six months, who meet criteria for early PTSD. Assessment of PTSD symptoms, brain markers, neuropsychological testing of memory, and cortisol response to an Iraq-related traumatic script before and after the intervention are proposed to provide information about the effects of the interventions on PTSD symptoms and stress-responsive hormonal systems.
Detailed description
Over 150,000 soldiers are currently deployed in Iraq as part of Operation Iraqi Freedom (OIF), and 12% of returning OIF veterans have posttraumatic stress disorder (PTSD). 389,100 soldiers developed chronic PTSD from the Vietnam War, requiring a life-time of VA mental health care. These veterans have suffered from a loss of work productivity, but also show greater utilization of health care resources and higher rates of physical disease. Research from our group and others showed lasting neurobiological consequences of PTSD, including an increased cortisol response to traumatic reminders, verbal declarative memory problems,6 and smaller hippocampal volume that reverses with treatment with the serotonin reuptake inhibitor (SSRI) paroxetine or the anticonvulsant phenytoin. Recently we found that three months of treatment with paroxetine in PTSD patients resulted in an increase in hippocampal N-acetyl-aspartate (NAA), a marker of neuronal integrity. Subjects treated with placebo did not have an increase in NAA, however subsequent treatment for three months with open label paroxetine resulted in an increase in NAA to the level seen in the subjects treated with paroxetine in the double-blind phase. Intervening soon after the trauma is critical for long-term outcomes, since with time traumatic memories become indelible and resistant to treatment. Diminished efficacy of treatment over time is shown by the fact that trials of Vietnam veterans have shown less efficacy over the years. Animal studies show that pretreatment before stress with antidepressants reduces chronic behavioral deficits related to stress; although for ethical and other reasons no studies have provided pretreatment before trauma exposure in humans. No studies have looked at the ability of antidepressants to treat early PTSD, which we are seeing in great numbers in veterans returning from OIF. This is important, since medications are not without side effects, and we cannot assume that early PTSD in Iraq veterans is the same as, for example, chronic Vietnam-related PTSD. Obtaining information about the risks and benefits of early treatment of PTSD in OIF veterans is critical to guiding treatment approaches to this emerging population. In addition, little is known about potential biomarkers of treatment response. We are working with the Georgia National Guard 48th Combat Brigade to evaluate the health needs of returning OIF veterans, and have started an OIF/OEF Trauma Clinic at the Atlanta VAMC where the PI is screening returning OIF veterans. We now propose to compare paroxetine and to placebo in returning OIF veterans who have returned from Iraq in the past six months, who meet criteria for early PTSD. Assessment of PTSD symptoms, hippocampal volume and NAA, neuropsychological testing of memory, and cortisol response to an Iraq-related traumatic script before and after the intervention are proposed to provide information about the effects of the interventions on PTSD symptoms and stress-responsive hormonal systems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: paroxetineparoxetine v placebo |
| 2 | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male and female veterans age 18-50
- Returned from Iraq Theater within the past six months
- Screen positive for PTSD related to Iraq deployment based on the PTSD Checklist
- Confirmed with PTSD based on the CAPS, including one month duration of symptoms
- Being discharged from active service from Iraq
Key exclusion criteria (12 listed)
- History of loss of consciousness of more than one minute
- Psychotropic medication use within the previous four weeks
- History (based on the SCID) of lifetime or current alcohol or substance abuse/dependence, schizophrenia, schizoaffective disorder, or bipolar disorder.
- Positive urine toxicology screen
- History of pre-deployment-related PTSD or partial PTSD based on the CAPS
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 |
|---|---|---|
| paroxetinetreatment with SSRI paroxetine | Drug | 1 |
| placebotreatment with placebo | Drug | 2 |
Primary outcome
CAPS
Time frame: three months
3 secondary outcomes
hippocampal volume and NAA
Time frame: three months
memory
Time frame: three months
cortisol response to stress
Time frame: three months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2015.
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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.
Doug Bremner, MD principal investigator
Atlanta VA Medical and Rehab Center, Decatur
Questions about this trial
What is this clinical trial studying?
A study testing paroxetine in people with Post-Traumatic Stress Disorders, run by US Department of Veterans Affairs.
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 6 inclusion and 12 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: withdrawn, as of the sponsor's last update on 26 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
CAPS (time frame: three months). 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 26 Jun 2015; AzTrials last refreshed its copy on 2 Nov 2026.