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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Other | Intervention-Paroxetine |
|
| Arm 2 | No Intervention | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paroxetine | Drug | Paroxetine 20-40mg po QD for 12 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| K. Luan Phan, MD | Jesse Brown VA Medical Center, Chicago, IL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jesse Brown VA Medical Center Community-Based Outpatient Clinic Lake Side Divison, Chicago, IL | Chicago | Illinois | 60611 | United States | ||
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 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Paroxetine) Group | Veterans returning from OEF/OIF with documented exposure to combat trauma who meet criteria for DSM-IV diagnosis of PTSD. Completed 12 weeks of treatment with paroxetine (20-40mg QD) |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Baseline Participants have been determined by the number of participants that completed the first MRI scan.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | Veterans returning from OEF/OIF with documented exposure to combat trauma who meet criteria for DSM-IV diagnosis of PTSD |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | percent change in BOLD signal | Baseline and 12 weeks |
|
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In the adverse events described below the total number of participants at risk for other adverse events is not consistent with the total number of participants at risk for other adverse events in the Arms/Groups i.e., "36" and "29" respectively. The numbers are correct due to only 22 participants having participated in the fMRI scans.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment (Paroxetine) Group | Veterans returning from OEF/OIF with documented exposure to combat trauma who meet criteria for DSM-IV diagnosis of PTSD |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychological/Emotional Adverse Event | Psychiatric disorders | Systematic Assessment | Increased anxiety reported at the study visit. Empathic listening, supportive responding provided. Unclear if increase in anxiety symptoms related to PTSD illness, current psychosocial stressors, and/or medication. No specific terms were collected. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. K Luan Phan | Jesse Brown VA Medical Center | 312-569-7161 | Kinh.Phan@va.gov |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D017374 | Paroxetine |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Jesse Brown VA Medical Center, Chicago, IL |
| Chicago |
| Illinois |
| 60612 |
| United States |
| VA Ann Arbor Healthcare System, Ann Arbor, MI | Ann Arbor | Michigan | 48113 | United States |
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Treatment (Paroxetine) Group |
Veterans returning from OEF/OIF with documented exposure to combat trauma who meet criteria for DSM-IV diagnosis of PTSD |
| OG001 | Combat Exposed Control | Veterans returning from OEF/OIF with documented exposure to combat trauma who do not meet criteria for DSM-IV diagnosis of PTSD. |
|
|
|
| 0 |
| 36 |
| 28 |
| 36 |
| EG001 | 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 | 0 | 29 | 1 | 29 |
|
| Anxiety experience during fMRI scanning | Psychiatric disorders | Non-systematic Assessment | Increased anxiety per subject report; Empathic listening & supportive responding was provided. The subject's mood & psychological/psychiatric symptoms did not warrant "ongoing psychotherapy treatment of any kind" beyond what was offered in the study |
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| Physical Side Effect to Medication - Blurred Vision | Psychiatric disorders | Systematic Assessment |
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| Physical Side Effect to Medication - Chest Pain | Psychiatric disorders | Systematic Assessment |
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| Physical Side Effect to Medication - Constipation | Psychiatric disorders | Systematic Assessment |
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| Physical Side Effect to Medication - Diarrhea | Psychiatric disorders | Systematic Assessment |
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| Physical Side Effect to Medication - Difficulty Urinating | Psychiatric disorders | Systematic Assessment |
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| Physical Side Effect to Medication - Difficulty with erections or sexual functioning | Psychiatric disorders | Systematic Assessment |
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| Physical Side Effect to Medication - Dizziness | Psychiatric disorders | Systematic Assessment |
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| Physical Side Effect to Medication - Drowsiness | Psychiatric disorders | Systematic Assessment |
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| Physical Side Effect to Medication - Dry mouth | Psychiatric disorders | Systematic Assessment |
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| Physical Side Effect to Medication - Feeling that familiar things are strange or unreal | Psychiatric disorders | Systematic Assessment |
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| Physical Side Effect to Medication - Headaches | Psychiatric disorders | Systematic Assessment |
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| Physical Side Effect to Medication - Heart pounding or racing | Psychiatric disorders | Systematic Assessment |
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| Physical Side Effect to Medication - Hot or cold spells | Psychiatric disorders | Systematic Assessment |
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| Physical Side Effect to Medication - Increased salivation | Psychiatric disorders | Systematic Assessment |
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| Physical Side Effect to Medication - Nausea | Psychiatric disorders | Systematic Assessment |
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| Physical Side Effect to Medication - Nervousness | Psychiatric disorders | Systematic Assessment |
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| Physical Side Effect to Medication - Numbness or tingling | Psychiatric disorders | Systematic Assessment |
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| Physical Side Effect to Medication - Overeating | Psychiatric disorders | Systematic Assessment |
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| Physical Side Effect to Medication - Panic | Psychiatric disorders | Systematic Assessment |
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| Physical Side Effect to Medication - Poor Appetite | Psychiatric disorders | Systematic Assessment |
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| Physical Side Effect to Medication - Soreness | Psychiatric disorders | Systematic Assessment |
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| Physical Side Effect to Medication - Sweating | Psychiatric disorders | Systematic Assessment |
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| Physical Side Effect to Medication - Tense | Psychiatric disorders | Systematic Assessment |
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| Physical Side Effect to Medication - Trembling | Psychiatric disorders | Systematic Assessment |
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| Physical Side Effect to Medication - Trouble falling asleep | Psychiatric disorders | Systematic Assessment |
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| Physical Side Effect to Medication - Trouble getting your breath | Psychiatric disorders | Systematic Assessment |
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| Physical Side Effect to Medication - Trouble remembering things | Psychiatric disorders | Systematic Assessment |
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| Physical Side Effect to Medication - Trouble staying asleep | Psychiatric disorders | Systematic Assessment |
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