Post-traumatic Stress Disorder
Conditions
Brief summary
The purpose of this study is to examine if treatment of post-traumatic stress disorder in combat veterans with paroxetine changes brain responses as measured by functional magnetic resonance imaging and if brain responses can predict who will get better with treatment.
Interventions
DRUGParoxetine
Paroxetine 20-40mg po QD for 12 weeks
Sponsors
US Department of Veterans Affairs
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Veterans with clinical diagnosis of post-traumatic stress disorder from combat related to deployment to Afghanistan/Iraq (Operation Enduring Freedom/Operation Iraqi Freedom)
Exclusion criteria
* Intolerance or sensitivity to paroxetine * Major medical or neurologic illness * Current psychotropic medication or active psychotherapy treatment * Other major psychiatric illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Brain Response Measured by Functional Magnetic Resonance Imaging (fMRI) | Baseline and 12 weeks | Mean percent change in brain response in the prefrontal cortex during an emotion reappraisal task in the treatment (paroxetine) group and in the Combat Exposed Control group. Target areas are analyzed from fMRI scans which were completed before participants receive treatment and again after participants received 12 weeks of treatment with paroxetine (20-40mg QD). Combat Exposed Control participants received an fMRI scan after signing initial consent and again 12 weeks later. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited in this study from 3/1/09 to 12/31/11. Participants were recruited by flyers in the community and within the Ann Arbor Veterans Affairs Health System and through professional referrals within the Ann Arbor Veterans Affairs Health System through the outpatient psychiatry clinics and primary care clinics.
Pre-assignment details
All participants went through an initial screening visit in which they signed the informed consent document and completed multiple assessments and a medical evaluation in order to assure that they were able to participate in the study and that they did not meet any exclusionary conditions.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group Veterans returning from OEF/OIF with documented exposure to combat trauma who meet criteria for DSM-IV diagnosis of PTSD | 29 |
| Combat Exposed Controls veterans returning from OEF/OIF with documented exposure to combat trauma who do not meet criteria for DSM-IV diagnosis of PTSD | 22 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Excluded - did not meet study criteria | 0 | 1 |
| Overall Study | Lost to Follow-up | 7 | 7 |
| Overall Study | Withdrawal by Subject | 8 | 1 |
Baseline characteristics
| Characteristic | Total | Treatment Group | Combat Exposed Controls |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants | 29 Participants | 22 Participants |
| Region of Enrollment United States | 51 participants | 29 participants | 22 participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 50 Participants | 29 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 28 / 36 | 1 / 29 |
| serious Total, serious adverse events | 0 / 36 | 0 / 29 |
Outcome results
Primary
Percent Change in Brain Response Measured by Functional Magnetic Resonance Imaging (fMRI)
Mean percent change in brain response in the prefrontal cortex during an emotion reappraisal task in the treatment (paroxetine) group and in the Combat Exposed Control group. Target areas are analyzed from fMRI scans which were completed before participants receive treatment and again after participants received 12 weeks of treatment with paroxetine (20-40mg QD). Combat Exposed Control participants received an fMRI scan after signing initial consent and again 12 weeks later.
Time frame: Baseline and 12 weeks
Population: The number of participants analyzed is only 17 in each arm. The total number of participants in the Intervention group who completed fMRI scans pre-treatment and post treatment is only 19, in the Combat Exposed Control Group it is 18. Three of the participants scans were removed from data analysis due to the level of movement during the scan.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment (Paroxetine) Group | Percent Change in Brain Response Measured by Functional Magnetic Resonance Imaging (fMRI) | -.92 percent change in BOLD signal | Standard Deviation 0.9 |
| Combat Exposed Control | Percent Change in Brain Response Measured by Functional Magnetic Resonance Imaging (fMRI) | .07 percent change in BOLD signal | Standard Deviation 1.78 |
p-value: 0.00195% CI: [-1.38, -0.45]t-test, 2 sided
p-value: 0.86995% CI: [-0.84, 0.99]t-test, 2 sided