Trial Outcomes & Findings for Predicting SSRI Efficacy in Veterans With PTSD (NCT NCT04183205)
NCT ID: NCT04183205
Last Updated: 2026-05-22
Results Overview
The CAPS-5 is the "gold standard" clinical interview for assessing PTSD. This measure will be used to characterize the sample regarding PTSD diagnosis and as a measure of PTSD severity. Each of the 20 symptoms of PTSD included in DSM-5 is rated on a 5-point scale ranging from 0-4, with a 0 or 1 indicating that the symptom is absent or subthreshold and a score of 2-4 indicating that a symptom has reached the threshold to be included as a symptom and ranges in severity from moderate to extreme. The total range of the CAPS-5 is 0-80, higher scores indicating higher symptom severity.
TERMINATED
PHASE4
26 participants
CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS score
2026-05-22
Participant Flow
There was no preassignment to group. All participants first completed a two week placebo lead-in phase. After the placebo lead-in phase, participants who made meaningful symptomatic reduction on the placebo (operationalized as more than 50% improvement on the PCL and QIDS-SR) during the placebo lead in phase remained on placebo for the duration of the trial. All other participants began the sertraline phase.
Participant milestones
| Measure |
Lead- in Phase
All participants were administered placebo pills of the same size, color and taste as the active drug for a two week period.
|
Placebo Only Arm
For individuals who are placebo responders during the 2 week placebo lead in phase, they will remain on placebo for the duration of the study (i.e., the 12 weeks where the placebo non-responders are taking sertraline).
LDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P2 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P2 scores.
Placebo: placebo pills of the same size, color and taste as the active drug will be administered
|
Sertraline Arm
After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.
LDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P2 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P2 scores.
Placebo: placebo pills of the same size, color and taste as the active drug will be administered
sertraline: Sertraline is an FDA approved SSRI for treatment of PTSD.
|
|---|---|---|---|
|
Lead-in Phase
STARTED
|
19
|
0
|
0
|
|
Lead-in Phase
COMPLETED
|
16
|
0
|
0
|
|
Lead-in Phase
NOT COMPLETED
|
3
|
0
|
0
|
|
Treatment Phase
STARTED
|
0
|
0
|
16
|
|
Treatment Phase
COMPLETED
|
0
|
0
|
12
|
|
Treatment Phase
NOT COMPLETED
|
0
|
0
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Predicting SSRI Efficacy in Veterans With PTSD
Baseline characteristics by cohort
| Measure |
Lead-in Phase
n=19 Participants
All participants were administered placebo pills of the same size, color and taste as the active drug for a two week period.
|
Placebo Only Arm
For individuals who are placebo responders during the 2 week placebo lead in phase, they will remain on placebo for the duration of the study (i.e., the 12 weeks where the placebo non-responders are taking sertraline).
LDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P2 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P2 scores.
Placebo: placebo pills of the same size, color and taste as the active drug will be administered
|
Sertraline Arm
After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.
LDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P2 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P2 scores.
Placebo: placebo pills of the same size, color and taste as the active drug will be administered
sertraline: Sertraline is an FDA approved SSRI for treatment of PTSD.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52.1 years
STANDARD_DEVIATION 14.5 • n=2 Participants
|
—
|
—
|
52.1 years
STANDARD_DEVIATION 14.5 • n=8 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=2 Participants
|
—
|
—
|
10 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=2 Participants
|
—
|
—
|
9 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=2 Participants
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=2 Participants
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=2 Participants
|
—
|
—
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=2 Participants
|
—
|
—
|
7 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=2 Participants
|
—
|
—
|
9 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=2 Participants
|
—
|
—
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=2 Participants
|
—
|
—
|
1 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=2 Participants
|
—
|
—
|
5 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=2 Participants
|
—
|
—
|
13 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=2 Participants
|
—
|
—
|
1 Participants
n=8 Participants
|
|
Region of Enrollment
United States · Boston site
|
18 Participants
n=2 Participants
|
—
|
—
|
18 Participants
n=8 Participants
|
|
Region of Enrollment
United States · Charleston site
|
1 Participants
n=2 Participants
|
—
|
—
|
1 Participants
n=8 Participants
|
|
Self-reported depression symptom severity
|
12.4 units on a scale
STANDARD_DEVIATION 5.01 • n=2 Participants
|
—
|
—
|
12.4 units on a scale
STANDARD_DEVIATION 5.01 • n=8 Participants
|
|
Self-reported PTSD symptom severity
|
38.1 units on a scale
STANDARD_DEVIATION 17.8 • n=2 Participants
|
—
|
—
|
38.1 units on a scale
STANDARD_DEVIATION 17.8 • n=8 Participants
|
PRIMARY outcome
Timeframe: CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS scorePopulation: Because of COVID and subsequent recruitment difficulties, we reduced the number of CAPS assessments to only screening and week 14. Thus, we had a very limited sample of participants who completed the 14 week study.
The CAPS-5 is the "gold standard" clinical interview for assessing PTSD. This measure will be used to characterize the sample regarding PTSD diagnosis and as a measure of PTSD severity. Each of the 20 symptoms of PTSD included in DSM-5 is rated on a 5-point scale ranging from 0-4, with a 0 or 1 indicating that the symptom is absent or subthreshold and a score of 2-4 indicating that a symptom has reached the threshold to be included as a symptom and ranges in severity from moderate to extreme. The total range of the CAPS-5 is 0-80, higher scores indicating higher symptom severity.
Outcome measures
| Measure |
Sertraline Arm
n=10 Participants
After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.
LDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P200 and N100 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P200 or N100 scores.
Placebo: placebo pills of the same size, color and taste as the active drug will be administered
sertraline: Sertraline is an FDA approved SSRI for treatment of PTSD.
|
|---|---|
|
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) After 14 Weeks of the Medication Trial Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the PZ Site) and Controlling for Baseline CAPS Score
|
10.8 Scores on a scale
Standard Deviation 9.95
|
PRIMARY outcome
Timeframe: CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS scorePopulation: Because of COVID and subsequent recruitment difficulties, we reduced the number of CAPS assessments to only screening and week 14. Thus, we had a very limited sample of participants who completed the 14 week study.
The CAPS-5 is the "gold standard" clinical interview for assessing PTSD. This measure will be used to characterize the sample regarding PTSD diagnosis and as a measure of PTSD severity. Each of the 20 symptoms of PTSD included in DSM-5 is rated on a 5-point scale ranging from 0-4, with a 0 or 1 indicating that the symptom is absent or subthreshold and a score of 2-4 indicating that a symptom has reached the threshold to be included as a symptom and ranges in severity from moderate to extreme. The total range of the CAPS-5 is 0-80, higher scores indicating higher symptom severity.
Outcome measures
| Measure |
Sertraline Arm
n=10 Participants
After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.
LDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P200 and N100 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P200 or N100 scores.
Placebo: placebo pills of the same size, color and taste as the active drug will be administered
sertraline: Sertraline is an FDA approved SSRI for treatment of PTSD.
|
|---|---|
|
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) After 14 Weeks of the Medication Trial as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the CZ Site) and Controlling for Baseline CAPS Score
|
10.8 Scores on a scale
Standard Deviation 9.95
|
PRIMARY outcome
Timeframe: CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS scorePopulation: Because of COVID and subsequent recruitment difficulties, we reduced the number of CAPS assessments to only screening and week 14. Thus, we had a very limited sample of participants who completed the 14 week study.
The CAPS-5 is the "gold standard" clinical interview for assessing PTSD. This measure will be used to characterize the sample regarding PTSD diagnosis and as a measure of PTSD severity. Each of the 20 symptoms of PTSD included in DSM-5 is rated on a 5-point scale ranging from 0-4, with a 0 or 1 indicating that the symptom is absent or subthreshold and a score of 2-4 indicating that a symptom has reached the threshold to be included as a symptom and ranges in severity from moderate to extreme. The total range of the CAPS-5 is 0-80, higher scores indicating higher symptom severity.
Outcome measures
| Measure |
Sertraline Arm
n=10 Participants
After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.
LDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P200 and N100 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P200 or N100 scores.
Placebo: placebo pills of the same size, color and taste as the active drug will be administered
sertraline: Sertraline is an FDA approved SSRI for treatment of PTSD.
|
|---|---|
|
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) After 14 Weeks of the Medication Trial as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the FZ Site) and Controlling for Baseline CAPS Score
|
10.8 Scores on a scale
Standard Deviation 25.7
|
PRIMARY outcome
Timeframe: CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS scorePopulation: Because of COVID and subsequent recruitment difficulties, we reduced the number of CAPS assessments to only screening and week 14. Thus, we had a very limited sample of participants who completed the 14 week study.
The CAPS-5 is the "gold standard" clinical interview for assessing PTSD. This measure will be used to characterize the sample regarding PTSD diagnosis and as a measure of PTSD severity. Each of the 20 symptoms of PTSD included in DSM-5 is rated on a 5-point scale ranging from 0-4, with a 0 or 1 indicating that the symptom is absent or subthreshold and a score of 2-4 indicating that a symptom has reached the threshold to be included as a symptom and ranges in severity from moderate to extreme. The total range of the CAPS-5 is 0-80, higher scores indicating higher symptom severity.
Outcome measures
| Measure |
Sertraline Arm
n=10 Participants
After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.
LDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P200 and N100 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P200 or N100 scores.
Placebo: placebo pills of the same size, color and taste as the active drug will be administered
sertraline: Sertraline is an FDA approved SSRI for treatment of PTSD.
|
|---|---|
|
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) After 14 Weeks of the Medication Trial Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the PZ Site) and Controlling for Baseline CAPS Score
|
10.8 Scores on a scale
Standard Deviation 9.95
|
PRIMARY outcome
Timeframe: CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS scorePopulation: Because of COVID and subsequent recruitment difficulties, we reduced the number of CAPS assessments to only screening and week 14. Thus, we had a very limited sample of participants who completed the 14 week study.
The CAPS-5 is the "gold standard" clinical interview for assessing PTSD. This measure will be used to characterize the sample regarding PTSD diagnosis and as a measure of PTSD severity. Each of the 20 symptoms of PTSD included in DSM-5 is rated on a 5-point scale ranging from 0-4, with a 0 or 1 indicating that the symptom is absent or subthreshold and a score of 2-4 indicating that a symptom has reached the threshold to be included as a symptom and ranges in severity from moderate to extreme. The total range of the CAPS-5 is 0-80, higher scores indicating higher symptom severity.
Outcome measures
| Measure |
Sertraline Arm
n=10 Participants
After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.
LDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P200 and N100 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P200 or N100 scores.
Placebo: placebo pills of the same size, color and taste as the active drug will be administered
sertraline: Sertraline is an FDA approved SSRI for treatment of PTSD.
|
|---|---|
|
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) After 14 Weeks of the Medication Trial Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the CZ Site) and Controlling for Baseline CAPS Score
|
10.8 Scores on a scale
Standard Deviation 9.95
|
PRIMARY outcome
Timeframe: CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS scorePopulation: Because of COVID and subsequent recruitment difficulties, we reduced the number of CAPS assessments to only screening and week 14. Thus, we had a very limited sample of participants who completed the 14 week study.
The CAPS-5 is the "gold standard" clinical interview for assessing PTSD. This measure will be used to characterize the sample regarding PTSD diagnosis and as a measure of PTSD severity. Each of the 20 symptoms of PTSD included in DSM-5 is rated on a 5-point scale ranging from 0-4, with a 0 or 1 indicating that the symptom is absent or subthreshold and a score of 2-4 indicating that a symptom has reached the threshold to be included as a symptom and ranges in severity from moderate to extreme. The total range of the CAPS-5 is 0-80, higher scores indicating higher symptom severity.
Outcome measures
| Measure |
Sertraline Arm
n=10 Participants
After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.
LDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P200 and N100 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P200 or N100 scores.
Placebo: placebo pills of the same size, color and taste as the active drug will be administered
sertraline: Sertraline is an FDA approved SSRI for treatment of PTSD.
|
|---|---|
|
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) After 14 Weeks of the Medication Trial Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the CZ Site) and Controlling for Baseline CAPS Score
|
10.8 Scores on a scale
Standard Deviation 9.95
|
SECONDARY outcome
Timeframe: Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14Population: Because of COVID and subsequent recruitment difficulties, there were only 19 participants with longitudinal QIDS-SR data for inclusion in these analyses.
The QIDS-SR was used to measure the severity of depressive symptoms. The QIDS provides equivalent weightings (0-3) for each symptom item, gives clearly stated anchors that estimate the frequency and severity of symptoms, and includes all items required to diagnose a major depressive episode. The range for the total QIDS-SR severity score is 0-42, with higher scores indicating worse depression severity.
Outcome measures
| Measure |
Sertraline Arm
n=19 Participants
After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.
LDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P200 and N100 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P200 or N100 scores.
Placebo: placebo pills of the same size, color and taste as the active drug will be administered
sertraline: Sertraline is an FDA approved SSRI for treatment of PTSD.
|
|---|---|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the PZ Site)
Week 0 QIDS-SR
|
11.50 Score on a scale
Standard Deviation 4.83
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the PZ Site)
Week 2 QIDS-SR
|
10.75 Score on a scale
Standard Deviation 4.27
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the PZ Site)
Week 4 QIDS-SR
|
10.5 Score on a scale
Standard Deviation 4.40
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the PZ Site)
Week 6 QIDS-SR
|
10.15 Score on a scale
Standard Deviation 5.00
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the PZ Site)
Week 8 QIDS-SR
|
9.89 Score on a scale
Standard Deviation 3.41
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the PZ Site)
Week 10 QIDS-SR
|
9.22 Score on a scale
Standard Deviation 4.55
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the PZ Site)
Week 12 QIDS-SR
|
9.43 Score on a scale
Standard Deviation 4.16
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the PZ Site)
Week 14 QIDS-SR
|
8.56 Score on a scale
Standard Deviation 3.78
|
SECONDARY outcome
Timeframe: Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14Population: Because of COVID and subsequent recruitment difficulties, there were only 19 participants with longitudinal QIDS-SR data for inclusion in these analyses.
The QIDS-SR was used to measure the severity of depressive symptoms. The QIDS provides equivalent weightings (0-3) for each symptom item, gives clearly stated anchors that estimate the frequency and severity of symptoms, and includes all items required to diagnose a major depressive episode. The range for the total QIDS-SR severity score is 0-42, with higher scores indicating worse depression severity.
Outcome measures
| Measure |
Sertraline Arm
n=19 Participants
After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.
LDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P200 and N100 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P200 or N100 scores.
Placebo: placebo pills of the same size, color and taste as the active drug will be administered
sertraline: Sertraline is an FDA approved SSRI for treatment of PTSD.
|
|---|---|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the CZ Site)
Week 4 QIDS-SR
|
10.5 Score on a scale
Standard Deviation 4.40
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the CZ Site)
Week 6 QIDS-SR
|
10.15 Score on a scale
Standard Deviation 5.00
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the CZ Site)
Week 0 QIDS-SR
|
11.5 Score on a scale
Standard Deviation 4.83
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the CZ Site)
Week 2 QIDS-SR
|
10.75 Score on a scale
Standard Deviation 2.67
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the CZ Site)
Week 8 QIDS-SR
|
9.89 Score on a scale
Standard Deviation 3.41
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the CZ Site)
Week 10 QIDS-SR
|
9.22 Score on a scale
Standard Deviation 4.55
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the CZ Site)
Week 12 QIDS-SR
|
9.43 Score on a scale
Standard Deviation 4.16
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the CZ Site)
Week 14 QIDS-SR
|
8.56 Score on a scale
Standard Deviation 3.78
|
SECONDARY outcome
Timeframe: Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14Population: Because of COVID and subsequent recruitment difficulties, there were only 19 participants with longitudinal QIDS-SR data for inclusion in these analyses.
The QIDS-SR was used to measure the severity of depressive symptoms. The QIDS provides equivalent weightings (0-3) for each symptom item, gives clearly stated anchors that estimate the frequency and severity of symptoms, and includes all items required to diagnose a major depressive episode. The range for the total QIDS-SR severity score is 0-42, with higher scores indicating worse depression severity.
Outcome measures
| Measure |
Sertraline Arm
n=19 Participants
After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.
LDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P200 and N100 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P200 or N100 scores.
Placebo: placebo pills of the same size, color and taste as the active drug will be administered
sertraline: Sertraline is an FDA approved SSRI for treatment of PTSD.
|
|---|---|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the PZ Site)
Week 0 QIDS-SR
|
11.5 Score on a scale
Standard Deviation 4.83
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the PZ Site)
Week 2 QIDS-SR
|
10.75 Score on a scale
Standard Deviation 4.27
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the PZ Site)
Week 4 QIDS-SR
|
10.50 Score on a scale
Standard Deviation 4.40
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the PZ Site)
Week 6 QIDS-SR
|
10.15 Score on a scale
Standard Deviation 5.00
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the PZ Site)
Week 8 QIDS-SR
|
9.89 Score on a scale
Standard Deviation 3.41
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the PZ Site)
Week 10 QIDS-SR
|
9.22 Score on a scale
Standard Deviation 4.55
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the PZ Site)
Week 12 QIDS-SR
|
9.43 Score on a scale
Standard Deviation 4.16
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the PZ Site)
Week 14 QIDS-SR
|
8.56 Score on a scale
Standard Deviation 3.78
|
SECONDARY outcome
Timeframe: Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14Population: Because of COVID and subsequent recruitment difficulties, there were only 19 participants with longitudinal QIDS-SR data for inclusion in these analyses.
The QIDS-SR was used to measure the severity of depressive symptoms. The QIDS provides equivalent weightings (0-3) for each symptom item, gives clearly stated anchors that estimate the frequency and severity of symptoms, and includes all items required to diagnose a major depressive episode. The range for the total QIDS-SR severity score is 0-42, with higher scores indicating worse depression severity.
Outcome measures
| Measure |
Sertraline Arm
n=19 Participants
After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.
LDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P200 and N100 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P200 or N100 scores.
Placebo: placebo pills of the same size, color and taste as the active drug will be administered
sertraline: Sertraline is an FDA approved SSRI for treatment of PTSD.
|
|---|---|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the FZ Site)
Week 0 QIDS-SR
|
11.5 Score on a scale
Standard Deviation 4.83
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the FZ Site)
Week 2 QIDS-SR
|
10.75 Score on a scale
Standard Deviation 4.27
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the FZ Site)
Week 4 QIDS-SR
|
10.5 Score on a scale
Standard Deviation 4.40
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the FZ Site)
Week 6 QIDS-SR
|
10.15 Score on a scale
Standard Deviation 5.00
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the FZ Site)
Week 8 QIDS-SR
|
9.89 Score on a scale
Standard Deviation 3.41
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the FZ Site)
Week 10 QIDS-SR
|
9.22 Score on a scale
Standard Deviation 4.55
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the FZ Site)
Week 12 QIDS-SR
|
9.43 Score on a scale
Standard Deviation 4.16
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the FZ Site)
Week 14 QIDS-SR
|
8.56 Score on a scale
Standard Deviation 3.78
|
SECONDARY outcome
Timeframe: Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14Population: Because of COVID and subsequent recruitment difficulties, there were only 19 participants with longitudinal QIDS-SR data for inclusion in these analyses.
The QIDS-SR was used to measure the severity of depressive symptoms. The QIDS provides equivalent weightings (0-3) for each symptom item, gives clearly stated anchors that estimate the frequency and severity of symptoms, and includes all items required to diagnose a major depressive episode. The range for the total QIDS-SR severity score is 0-42, with higher scores indicating worse depression severity.
Outcome measures
| Measure |
Sertraline Arm
n=19 Participants
After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.
LDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P200 and N100 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P200 or N100 scores.
Placebo: placebo pills of the same size, color and taste as the active drug will be administered
sertraline: Sertraline is an FDA approved SSRI for treatment of PTSD.
|
|---|---|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the CZ Site)
Week 0 QIDS-SR
|
11.5 Score on a scale
Standard Deviation 4.83
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the CZ Site)
Week 2 QIDS-SR
|
10.75 Score on a scale
Standard Deviation 4.27
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the CZ Site)
Week 4 QIDS-SR
|
10.5 Score on a scale
Standard Deviation 4.40
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the CZ Site)
Week 6 QIDS-SR
|
10.15 Score on a scale
Standard Deviation 5.0
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the CZ Site)
Week 8 QIDS-SR
|
9.89 Score on a scale
Standard Deviation 3.41
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the CZ Site)
Week 10 QIDS-SR
|
9.22 Score on a scale
Standard Deviation 4.55
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the CZ Site)
Week 12 QIDS-SR
|
9.43 Score on a scale
Standard Deviation 4.16
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the CZ Site)
Week 14 QIDS-SR
|
8.56 Score on a scale
Standard Deviation 3.78
|
SECONDARY outcome
Timeframe: Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14Population: Because of COVID and subsequent recruitment difficulties, there were only 19 participants with longitudinal QIDS-SR data for inclusion in these analyses.
The QIDS-SR was used to measure the severity of depressive symptoms. The QIDS provides equivalent weightings (0-3) for each symptom item, gives clearly stated anchors that estimate the frequency and severity of symptoms, and includes all items required to diagnose a major depressive episode. The range for the total QIDS-SR severity score is 0-42, with higher scores indicating worse depression severity.
Outcome measures
| Measure |
Sertraline Arm
n=19 Participants
After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.
LDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P200 and N100 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P200 or N100 scores.
Placebo: placebo pills of the same size, color and taste as the active drug will be administered
sertraline: Sertraline is an FDA approved SSRI for treatment of PTSD.
|
|---|---|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the PZ Site)
Week 0 QIDS-SR
|
11.5 Score on a scale
Standard Deviation 4.83
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the PZ Site)
Week 2 QIDS-SR
|
10.75 Score on a scale
Standard Deviation 4.27
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the PZ Site)
Week 4 QIDS-SR
|
10.5 Score on a scale
Standard Deviation 4.40
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the PZ Site)
Week 6 QIDS-SR
|
10.15 Score on a scale
Standard Deviation 5.00
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the PZ Site)
Week 8 QIDS-SR
|
9.89 Score on a scale
Standard Deviation 3.41
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the PZ Site)
Week 10 QIDS-SR
|
9.22 Score on a scale
Standard Deviation 4.55
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the PZ Site)
Week 12 QIDS-SR
|
9.43 Score on a scale
Standard Deviation 4.16
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the PZ Site)
Week 14 QIDS-SR
|
8.56 Score on a scale
Standard Deviation 3.78
|
SECONDARY outcome
Timeframe: Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14Population: Because of COVID and subsequent recruitment difficulties, there were only 19 participants with longitudinal PCL data for inclusion in these analyses.
The PCL-5 is a 20-item measure that assesses DSM-5 symptoms of PTSD, anchored to participants' worst traumatic event. The PCL-5 was administered bi-weekly at each psychiatrist check-in visit. Participants rated how much they experienced each symptom on a 5-point Likert-type scale (0 = "not at all" to 4 = "extremely") during the past week (total range=0-80). Higher scores indicate greater PTSD severity.
Outcome measures
| Measure |
Sertraline Arm
n=19 Participants
After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.
LDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P200 and N100 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P200 or N100 scores.
Placebo: placebo pills of the same size, color and taste as the active drug will be administered
sertraline: Sertraline is an FDA approved SSRI for treatment of PTSD.
|
|---|---|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the FZ Site)
Week 0 PCL-5
|
31.39 Score on a scale
Standard Deviation 19.56
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the FZ Site)
Week 2 PCL-5
|
29.19 Score on a scale
Standard Deviation 17.22
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the FZ Site)
Week 4 PCL-5
|
26.30 Score on a scale
Standard Deviation 16.69
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the FZ Site)
Week 6 PCL-5
|
25.93 Score on a scale
Standard Deviation 16.79
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the FZ Site)
Week 8 PCL-5
|
17.89 Score on a scale
Standard Deviation 14.40
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the FZ Site)
Week 10 PCL-5
|
20.22 Score on a scale
Standard Deviation 16.04
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the FZ Site)
Week 12 PCL-5
|
16.71 Score on a scale
Standard Deviation 10.36
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the FZ Site)
Week 14 PCL-5
|
17.33 Score on a scale
Standard Deviation 11.57
|
SECONDARY outcome
Timeframe: Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14Population: Because of COVID and subsequent recruitment difficulties, there were only 19 participants with longitudinal PCL data for inclusion in these analyses.
The PCL-5 is a 20-item measure that assesses DSM-5 symptoms of PTSD, anchored to participants' worst traumatic event. The PCL-5 was administered bi-weekly at each psychiatrist check-in visit. Participants rated how much they experienced each symptom on a 5-point Likert-type scale (0 = "not at all" to 4 = "extremely") during the past week (total range=0-80). Higher scores indicate greater PTSD severity.
Outcome measures
| Measure |
Sertraline Arm
n=14 Participants
After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.
LDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P200 and N100 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P200 or N100 scores.
Placebo: placebo pills of the same size, color and taste as the active drug will be administered
sertraline: Sertraline is an FDA approved SSRI for treatment of PTSD.
|
|---|---|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the CZ Site)
Week 0 PCL-5
|
31.39 Score on a scale
Standard Deviation 19.56
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the CZ Site)
Week 2 PCL-5
|
29.19 Score on a scale
Standard Deviation 17.22
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the CZ Site)
Week 4 PCL-5
|
26.30 Score on a scale
Standard Deviation 16.69
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the CZ Site)
Week 6 PCL-5
|
25.93 Score on a scale
Standard Deviation 16.79
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the CZ Site)
Week 8 PCL-5
|
17.89 Score on a scale
Standard Deviation 14.40
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the CZ Site)
Week 10 PCL-5
|
20.22 Score on a scale
Standard Deviation 16.04
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the CZ Site)
Week 12 PCL-5
|
16.71 Score on a scale
Standard Deviation 10.36
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the CZ Site)
Week 14 PCL-5
|
17.33 Score on a scale
Standard Deviation 11.57
|
SECONDARY outcome
Timeframe: Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14Population: Because of COVID and subsequent recruitment difficulties, there were only 19 participants with longitudinal PCL data for inclusion in these analyses.
The PCL-5 is a 20-item measure that assesses DSM-5 symptoms of PTSD, anchored to participants' worst traumatic event. The PCL-5 was administered bi-weekly at each psychiatrist check-in visit. Participants rated how much they experienced each symptom on a 5-point Likert-type scale (0 = "not at all" to 4 = "extremely") during the past week (total range=0-80). Higher scores indicate greater PTSD severity.
Outcome measures
| Measure |
Sertraline Arm
n=19 Participants
After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.
LDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P200 and N100 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P200 or N100 scores.
Placebo: placebo pills of the same size, color and taste as the active drug will be administered
sertraline: Sertraline is an FDA approved SSRI for treatment of PTSD.
|
|---|---|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the PZ Site)
Week 0 PCL-5
|
31.39 Score on a scale
Standard Deviation 19.56
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the PZ Site)
Week 2 PCL-5
|
29.19 Score on a scale
Standard Deviation 17.22
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the PZ Site)
Week 4 PCL-5
|
26.30 Score on a scale
Standard Deviation 16.69
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the PZ Site)
Week 6 PCL-5
|
25.93 Score on a scale
Standard Deviation 16.79
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the PZ Site)
Week 8 PCL-5
|
17.89 Score on a scale
Standard Deviation 14.40
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the PZ Site)
Week 10 PCL-5
|
20.22 Score on a scale
Standard Deviation 16.04
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the PZ Site)
Week 12 PCL-5
|
16.71 Score on a scale
Standard Deviation 10.36
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the PZ Site)
Week 14 PCL-5
|
17.33 Score on a scale
Standard Deviation 11.57
|
SECONDARY outcome
Timeframe: Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14Population: Because of COVID and subsequent recruitment difficulties, there were only 19 participants with longitudinal PCL data for inclusion in these analyses.
The PCL-5 is a 20-item measure that assesses DSM-5 symptoms of PTSD, anchored to participants' worst traumatic event. The PCL-5 was administered bi-weekly at each psychiatrist check-in visit. Participants rated how much they experienced each symptom on a 5-point Likert-type scale (0 = "not at all" to 4 = "extremely") during the past week (total range=0-80). Higher scores indicate greater PTSD severity.
Outcome measures
| Measure |
Sertraline Arm
n=19 Participants
After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.
LDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P200 and N100 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P200 or N100 scores.
Placebo: placebo pills of the same size, color and taste as the active drug will be administered
sertraline: Sertraline is an FDA approved SSRI for treatment of PTSD.
|
|---|---|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the FZ Site)
Week 0 PCL-5
|
31.39 Score on a scale
Standard Deviation 19.56
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the FZ Site)
Week 2 PCL-5
|
29.19 Score on a scale
Standard Deviation 17.22
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the FZ Site)
Week 4 PCL-5
|
26.30 Score on a scale
Standard Deviation 16.69
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the FZ Site)
Week 6 PCL-5
|
25.93 Score on a scale
Standard Deviation 16.79
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the FZ Site)
Week 8 PCL-5
|
17.89 Score on a scale
Standard Deviation 14.40
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the FZ Site)
Week 10 PCL-5
|
20.22 Score on a scale
Standard Deviation 16.04
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the FZ Site)
Week 12 PCL-5
|
16.71 Score on a scale
Standard Deviation 10.36
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the FZ Site)
Week 14 PCL-5
|
17.33 Score on a scale
Standard Deviation 11.57
|
SECONDARY outcome
Timeframe: Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14Population: Because of COVID and subsequent recruitment difficulties, there were only 19 participants with longitudinal PCL data for inclusion in these analyses.
The PCL-5 is a 20-item measure that assesses DSM-5 symptoms of PTSD, anchored to participants' worst traumatic event. The PCL-5 was administered bi-weekly at each psychiatrist check-in visit. Participants rated how much they experienced each symptom on a 5-point Likert-type scale (0 = "not at all" to 4 = "extremely") during the past week (total range=0-80). Higher scores indicate greater PTSD severity.
Outcome measures
| Measure |
Sertraline Arm
n=19 Participants
After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.
LDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P200 and N100 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P200 or N100 scores.
Placebo: placebo pills of the same size, color and taste as the active drug will be administered
sertraline: Sertraline is an FDA approved SSRI for treatment of PTSD.
|
|---|---|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the CZ Site)
Week 14 PCL-5
|
17.33 Score on a scale
Standard Deviation 11.57
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the CZ Site)
Week 0 PCL-5
|
31.39 Score on a scale
Standard Deviation 19.56
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the CZ Site)
Week 2 PCL-5
|
29.19 Score on a scale
Standard Deviation 17.22
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the CZ Site)
Week 4 PCL-5
|
26.30 Score on a scale
Standard Deviation 16.69
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the CZ Site)
Week 6 PCL-5
|
25.93 Score on a scale
Standard Deviation 16.79
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the CZ Site)
Week 8 PCL-5
|
17.89 Score on a scale
Standard Deviation 14.40
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the CZ Site)
Week 10 PCL-5
|
20.22 Score on a scale
Standard Deviation 16.04
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the CZ Site)
Week 12 PCL-5
|
16.71 Score on a scale
Standard Deviation 10.36
|
SECONDARY outcome
Timeframe: Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14Population: Because of COVID and subsequent recruitment difficulties, there were only 19 participants with longitudinal PCL data for inclusion in these analyses.
The PCL-5 is a 20-item measure that assesses DSM-5 symptoms of PTSD, anchored to participants' worst traumatic event. The PCL-5 was administered bi-weekly at each psychiatrist check-in visit. Participants rated how much they experienced each symptom on a 5-point Likert-type scale (0 = "not at all" to 4 = "extremely") during the past week (total range=0-80). Higher scores indicate greater PTSD severity.
Outcome measures
| Measure |
Sertraline Arm
n=19 Participants
After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.
LDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P200 and N100 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P200 or N100 scores.
Placebo: placebo pills of the same size, color and taste as the active drug will be administered
sertraline: Sertraline is an FDA approved SSRI for treatment of PTSD.
|
|---|---|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the PZ Site)
Week 0 PCL-5
|
31.39 Score on a scale
Standard Deviation 19.56
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the PZ Site)
Week 2 PCL-5
|
29.19 Score on a scale
Standard Deviation 17.22
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the PZ Site)
Week 4 PCL-5
|
26.30 Score on a scale
Standard Deviation 16.69
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the PZ Site)
Week 6 PCL-5
|
25.93 Score on a scale
Standard Deviation 16.79
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the PZ Site)
Week 8 PCL-5
|
17.89 Score on a scale
Standard Deviation 14.40
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the PZ Site)
Week 10 PCL-5
|
20.22 Score on a scale
Standard Deviation 16.04
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the PZ Site)
Week 12 PCL-5
|
16.71 Score on a scale
Standard Deviation 10.36
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the PZ Site)
Week 14 PCL-5
|
17.33 Score on a scale
Standard Deviation 11.57
|
Adverse Events
Lead-in Phase
Placebo Only Arm
Sertraline Arm
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lead-in Phase
n=19 participants at risk
All participants were administered placebo pills of the same size, color and taste as the active drug for a two week period.
|
Placebo Only Arm
For individuals who are placebo responders during the 2 week placebo lead in phase, they will remain on placebo for the duration of the study (i.e., the 12 weeks where the placebo non-responders are taking sertraline).
|
Sertraline Arm
n=16 participants at risk
After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.
LDAEP: This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P200 and N100 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P200 or N100 scores.
Placebo: placebo pills of the same size, color and taste as the active drug will be administered
sertraline: Sertraline is an FDA approved SSRI for treatment of PTSD.
|
|---|---|---|---|
|
General disorders
environmental allergies
|
5.3%
1/19 • from enrollment until end of follow-up, up to 17 weeks.
There were no participants in the placebo only arm.
|
—
0/0 • from enrollment until end of follow-up, up to 17 weeks.
There were no participants in the placebo only arm.
|
12.5%
2/16 • from enrollment until end of follow-up, up to 17 weeks.
There were no participants in the placebo only arm.
|
|
General disorders
headaches
|
5.3%
1/19 • from enrollment until end of follow-up, up to 17 weeks.
There were no participants in the placebo only arm.
|
—
0/0 • from enrollment until end of follow-up, up to 17 weeks.
There were no participants in the placebo only arm.
|
12.5%
2/16 • from enrollment until end of follow-up, up to 17 weeks.
There were no participants in the placebo only arm.
|
|
Cardiac disorders
abnormal EKG
|
21.1%
4/19 • from enrollment until end of follow-up, up to 17 weeks.
There were no participants in the placebo only arm.
|
—
0/0 • from enrollment until end of follow-up, up to 17 weeks.
There were no participants in the placebo only arm.
|
25.0%
4/16 • from enrollment until end of follow-up, up to 17 weeks.
There were no participants in the placebo only arm.
|
|
Psychiatric disorders
increased depression symptoms
|
5.3%
1/19 • from enrollment until end of follow-up, up to 17 weeks.
There were no participants in the placebo only arm.
|
—
0/0 • from enrollment until end of follow-up, up to 17 weeks.
There were no participants in the placebo only arm.
|
12.5%
2/16 • from enrollment until end of follow-up, up to 17 weeks.
There were no participants in the placebo only arm.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place