Trial Outcomes & Findings for Brain Markers of Treatment Response in Post-Traumatic Stress Disorder (PTSD) (NCT NCT00700999)
NCT ID: NCT00700999
Last Updated: 2014-06-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
65 participants
Primary outcome timeframe
Baseline and 12 weeks
Results posted on
2014-06-03
Participant Flow
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.
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.
Participant milestones
| Measure |
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)
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
29
|
|
Overall Study
First MRI Scan
|
29
|
22
|
|
Overall Study
Second MRI Scan
|
19
|
18
|
|
Overall Study
COMPLETED
|
21
|
20
|
|
Overall Study
NOT COMPLETED
|
15
|
9
|
Reasons for withdrawal
| Measure |
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)
|
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
7
|
|
Overall Study
Excluded - did not meet study criteria
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
8
|
1
|
Baseline Characteristics
Brain Markers of Treatment Response in Post-Traumatic Stress Disorder (PTSD)
Baseline characteristics by cohort
| Measure |
Treatment Group
n=29 Participants
Veterans returning from OEF/OIF with documented exposure to combat trauma who meet criteria for DSM-IV diagnosis of PTSD
|
Combat Exposed Controls
n=22 Participants
veterans returning from OEF/OIF with documented exposure to combat trauma who do not meet criteria for DSM-IV diagnosis of PTSD
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
22 participants
n=7 Participants
|
51 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Treatment (Paroxetine) Group
n=17 Participants
Veterans returning from OEF/OIF with documented exposure to combat trauma who meet criteria for DSM-IV diagnosis of PTSD
|
Combat Exposed Control
n=17 Participants
Veterans returning from OEF/OIF with documented exposure to combat trauma who do not meet criteria for DSM-IV diagnosis of PTSD.
|
|---|---|---|
|
Percent Change in Brain Response Measured by Functional Magnetic Resonance Imaging (fMRI)
|
-.92 percent change in BOLD signal
Standard Deviation 0.90
|
.07 percent change in BOLD signal
Standard Deviation 1.78
|
Adverse Events
Treatment (Paroxetine) Group
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Combat Exposed Controls
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment (Paroxetine) Group
n=36 participants at risk
Veterans returning from OEF/OIF with documented exposure to combat trauma who meet criteria for DSM-IV diagnosis of PTSD
|
Combat Exposed Controls
n=29 participants at risk
Veterans returning from OEF/OIF with documented exposure to combat trauma who do not meet criteria for DSM-IV diagnosis of PTSD
|
|---|---|---|
|
Psychiatric disorders
Psychological/Emotional Adverse Event
|
17.9%
5/28 • Number of events 5
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.
|
0.00%
0/29
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.
|
|
Psychiatric disorders
Anxiety experience during fMRI scanning
|
6.9%
2/29 • Number of events 2
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.
|
4.5%
1/22 • Number of events 1
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.
|
|
Psychiatric disorders
Physical Side Effect to Medication - Blurred Vision
|
22.2%
8/36 • Number of events 8
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.
|
—
0/0
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.
|
|
Psychiatric disorders
Physical Side Effect to Medication - Chest Pain
|
19.4%
7/36 • Number of events 7
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.
|
—
0/0
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.
|
|
Psychiatric disorders
Physical Side Effect to Medication - Constipation
|
22.2%
8/36 • Number of events 8
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.
|
—
0/0
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.
|
|
Psychiatric disorders
Physical Side Effect to Medication - Diarrhea
|
25.0%
9/36 • Number of events 9
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.
|
—
0/0
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.
|
|
Psychiatric disorders
Physical Side Effect to Medication - Difficulty Urinating
|
5.6%
2/36 • Number of events 2
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.
|
—
0/0
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.
|
|
Psychiatric disorders
Physical Side Effect to Medication - Difficulty with erections or sexual functioning
|
47.2%
17/36 • Number of events 17
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.
|
—
0/0
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.
|
|
Psychiatric disorders
Physical Side Effect to Medication - Dizziness
|
36.1%
13/36 • Number of events 13
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.
|
—
0/0
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.
|
|
Psychiatric disorders
Physical Side Effect to Medication - Drowsiness
|
66.7%
24/36 • Number of events 24
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.
|
—
0/0
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.
|
|
Psychiatric disorders
Physical Side Effect to Medication - Dry mouth
|
38.9%
14/36 • Number of events 14
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.
|
—
0/0
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.
|
|
Psychiatric disorders
Physical Side Effect to Medication - Feeling that familiar things are strange or unreal
|
25.0%
9/36 • Number of events 9
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.
|
—
0/0
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.
|
|
Psychiatric disorders
Physical Side Effect to Medication - Headaches
|
66.7%
24/36 • Number of events 24
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.
|
—
0/0
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.
|
|
Psychiatric disorders
Physical Side Effect to Medication - Heart pounding or racing
|
55.6%
20/36 • Number of events 20
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.
|
—
0/0
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.
|
|
Psychiatric disorders
Physical Side Effect to Medication - Hot or cold spells
|
30.6%
11/36 • Number of events 11
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.
|
—
0/0
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.
|
|
Psychiatric disorders
Physical Side Effect to Medication - Increased salivation
|
5.6%
2/36 • Number of events 2
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.
|
—
0/0
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.
|
|
Psychiatric disorders
Physical Side Effect to Medication - Nausea
|
47.2%
17/36 • Number of events 17
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.
|
—
0/0
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.
|
|
Psychiatric disorders
Physical Side Effect to Medication - Nervousness
|
50.0%
18/36 • Number of events 18
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.
|
—
0/0
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.
|
|
Psychiatric disorders
Physical Side Effect to Medication - Numbness or tingling
|
41.7%
15/36 • Number of events 15
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.
|
—
0/0
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.
|
|
Psychiatric disorders
Physical Side Effect to Medication - Overeating
|
33.3%
12/36 • Number of events 12
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.
|
—
0/0
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.
|
|
Psychiatric disorders
Physical Side Effect to Medication - Panic
|
36.1%
13/36 • Number of events 13
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.
|
—
0/0
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.
|
|
Psychiatric disorders
Physical Side Effect to Medication - Poor Appetite
|
47.2%
17/36 • Number of events 17
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.
|
—
0/0
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.
|
|
Psychiatric disorders
Physical Side Effect to Medication - Soreness
|
63.9%
23/36 • Number of events 23
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.
|
—
0/0
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.
|
|
Psychiatric disorders
Physical Side Effect to Medication - Sweating
|
41.7%
15/36 • Number of events 15
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.
|
—
0/0
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.
|
|
Psychiatric disorders
Physical Side Effect to Medication - Tense
|
69.4%
25/36 • Number of events 25
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.
|
—
0/0
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.
|
|
Psychiatric disorders
Physical Side Effect to Medication - Trembling
|
33.3%
12/36 • Number of events 12
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.
|
—
0/0
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.
|
|
Psychiatric disorders
Physical Side Effect to Medication - Trouble falling asleep
|
69.4%
25/36 • Number of events 25
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.
|
—
0/0
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.
|
|
Psychiatric disorders
Physical Side Effect to Medication - Trouble getting your breath
|
22.2%
8/36 • Number of events 8
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.
|
—
0/0
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.
|
|
Psychiatric disorders
Physical Side Effect to Medication - Trouble remembering things
|
72.2%
26/36 • Number of events 26
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.
|
—
0/0
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.
|
|
Psychiatric disorders
Physical Side Effect to Medication - Trouble staying asleep
|
66.7%
24/36 • Number of events 24
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.
|
—
0/0
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place