Trial Outcomes & Findings for PROlonGed ExpoSure Sertraline (NCT NCT01524133)
NCT ID: NCT01524133
Last Updated: 2018-02-28
Results Overview
Total Score; Range 0-136 with increasing PTSD severity as scores increase
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
223 participants
Primary outcome timeframe
24 weeks
Results posted on
2018-02-28
Participant Flow
Patients were informed of assignment at first treatment visit. Only those randomized patients who started treatment are included below (16 patients never started treatment. They did not know condition assignment.).
Participant milestones
| Measure |
Sertraline + Enhanced Medication Management (SERT/EMM)
24 weeks of sertraline + enhanced medication management
Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.
|
Prolonged Exposure + Sertraline (PE/SERT)
Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline
Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.
Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure
|
Prolonged Exposure + Placebo (PE/PLB)
Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo
Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure
|
|---|---|---|---|
|
Treatment Phase
STARTED
|
71
|
69
|
67
|
|
Treatment Phase
COMPLETED
|
52
|
37
|
31
|
|
Treatment Phase
NOT COMPLETED
|
19
|
32
|
36
|
|
Overall Study 52 Weeks
STARTED
|
71
|
69
|
67
|
|
Overall Study 52 Weeks
COMPLETED
|
50
|
49
|
40
|
|
Overall Study 52 Weeks
NOT COMPLETED
|
21
|
20
|
27
|
Reasons for withdrawal
| Measure |
Sertraline + Enhanced Medication Management (SERT/EMM)
24 weeks of sertraline + enhanced medication management
Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.
|
Prolonged Exposure + Sertraline (PE/SERT)
Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline
Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.
Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure
|
Prolonged Exposure + Placebo (PE/PLB)
Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo
Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure
|
|---|---|---|---|
|
Treatment Phase
Withdrawal by Subject
|
13
|
28
|
31
|
|
Treatment Phase
Physician Decision
|
6
|
3
|
3
|
|
Treatment Phase
Lost to Follow-up
|
0
|
1
|
2
|
|
Overall Study 52 Weeks
Withdrawal by Subject
|
4
|
5
|
10
|
|
Overall Study 52 Weeks
Physician Decision
|
1
|
0
|
2
|
|
Overall Study 52 Weeks
Lost to Follow-up
|
16
|
15
|
15
|
Baseline Characteristics
PROlonGed ExpoSure Sertraline
Baseline characteristics by cohort
| Measure |
Sertraline + Enhanced Medication Management (SERT/EMM)
n=71 Participants
24 weeks of sertraline + enhanced medication management
Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.
|
Prolonged Exposure + Sertraline (PE/SERT)
n=69 Participants
Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline
Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.
Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure
|
Prolonged Exposure + Placebo (PE/PLB)
n=67 Participants
Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo
Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure
|
Total
n=207 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
33.7 years
STANDARD_DEVIATION 8.2 • n=93 Participants
|
35.1 years
STANDARD_DEVIATION 8.5 • n=4 Participants
|
34.7 years
STANDARD_DEVIATION 8.3 • n=27 Participants
|
34.5 years
STANDARD_DEVIATION 8.3 • n=483 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
27 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=93 Participants
|
55 Participants
n=4 Participants
|
59 Participants
n=27 Participants
|
180 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
31 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=93 Participants
|
59 Participants
n=4 Participants
|
60 Participants
n=27 Participants
|
176 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
43 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
119 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Race · African American
|
20 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
62 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
8 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
26 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
71 Participants
n=93 Participants
|
69 Participants
n=4 Participants
|
67 Participants
n=27 Participants
|
207 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: All randomized patients who received treatment
Total Score; Range 0-136 with increasing PTSD severity as scores increase
Outcome measures
| Measure |
Sertraline + Enhanced Medication Management (SERT/EMM)
n=71 Participants
24 weeks of sertraline + enhanced medication management
Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.
|
Prolonged Exposure + Sertraline (PE/SERT)
n=69 Participants
Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline
Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.
Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure
|
Prolonged Exposure + Placebo (PE/PLB)
n=67 Participants
Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo
Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure
|
|---|---|---|---|
|
Posttraumatic Stress Disorder (PTSD) Symptoms as Measured by the Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)
|
41.7 Scores on a scale
Standard Deviation 25.7
|
43.3 Scores on a scale
Standard Deviation 27.2
|
51.5 Scores on a scale
Standard Deviation 25.3
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: All Randomized patients who received treatment and had the measure
PHQ-15; measures somatization and ranges from 0 to 30 and 0-9 is considered minimal/low, 10-14 is moderate, and 15-30 is severe
Outcome measures
| Measure |
Sertraline + Enhanced Medication Management (SERT/EMM)
n=71 Participants
24 weeks of sertraline + enhanced medication management
Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.
|
Prolonged Exposure + Sertraline (PE/SERT)
n=69 Participants
Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline
Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.
Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure
|
Prolonged Exposure + Placebo (PE/PLB)
n=67 Participants
Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo
Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure
|
|---|---|---|---|
|
Patient Health Questionnaire-15
|
8.6 Scores on a scale
Standard Deviation 5.7
|
9.8 Scores on a scale
Standard Deviation 5.7
|
10.5 Scores on a scale
Standard Deviation 5.1
|
Adverse Events
Sertraline + Enhanced Medication Management (SERT/EMM)
Serious events: 0 serious events
Other events: 69 other events
Deaths: 0 deaths
Prolonged Exposure + Sertraline (PE/SERT)
Serious events: 5 serious events
Other events: 61 other events
Deaths: 0 deaths
Prolonged Exposure + Placebo (PE/PLB)
Serious events: 3 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sertraline + Enhanced Medication Management (SERT/EMM)
n=71 participants at risk
24 weeks of sertraline + enhanced medication management
Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.
|
Prolonged Exposure + Sertraline (PE/SERT)
n=69 participants at risk
Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline
Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.
Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure
|
Prolonged Exposure + Placebo (PE/PLB)
n=67 participants at risk
Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo
Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure
|
|---|---|---|---|
|
Psychiatric disorders
Increased Suicidal Ideation
|
0.00%
0/71 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
4.3%
3/69 • Number of events 3 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
3.0%
2/67 • Number of events 2 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
|
Psychiatric disorders
Increased Depression
|
0.00%
0/71 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
0.00%
0/69 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
1.5%
1/67 • Number of events 1 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
|
Psychiatric disorders
Increased Irritability
|
0.00%
0/71 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
1.4%
1/69 • Number of events 1 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
0.00%
0/67 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
|
Gastrointestinal disorders
dyspepsia
|
0.00%
0/71 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
1.4%
1/69 • Number of events 1 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
0.00%
0/67 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
Other adverse events
| Measure |
Sertraline + Enhanced Medication Management (SERT/EMM)
n=71 participants at risk
24 weeks of sertraline + enhanced medication management
Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.
|
Prolonged Exposure + Sertraline (PE/SERT)
n=69 participants at risk
Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline
Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.
Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure
|
Prolonged Exposure + Placebo (PE/PLB)
n=67 participants at risk
Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo
Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure
|
|---|---|---|---|
|
Cardiac disorders
Cardiovascular
|
2.8%
2/71 • Number of events 2 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
2.9%
2/69 • Number of events 2 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
6.0%
4/67 • Number of events 6 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
|
Skin and subcutaneous tissue disorders
Dermatological
|
2.8%
2/71 • Number of events 2 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
1.4%
1/69 • Number of events 1 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
4.5%
3/67 • Number of events 3 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
|
Endocrine disorders
Endocrine
|
8.5%
6/71 • Number of events 7 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
1.4%
1/69 • Number of events 1 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
0.00%
0/67 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
|
Gastrointestinal disorders
Gastrointestinal
|
69.0%
49/71 • Number of events 94 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
49.3%
34/69 • Number of events 68 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
29.9%
20/67 • Number of events 39 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
|
Renal and urinary disorders
Genitourinary
|
35.2%
25/71 • Number of events 36 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
24.6%
17/69 • Number of events 25 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
10.4%
7/67 • Number of events 7 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
|
Blood and lymphatic system disorders
Hematological
|
1.4%
1/71 • Number of events 1 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
0.00%
0/69 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
1.5%
1/67 • Number of events 1 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
|
Musculoskeletal and connective tissue disorders
Muskuloskeletal
|
8.5%
6/71 • Number of events 6 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
13.0%
9/69 • Number of events 9 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
4.5%
3/67 • Number of events 4 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
|
Nervous system disorders
Neurological
|
38.0%
27/71 • Number of events 38 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
31.9%
22/69 • Number of events 29 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
20.9%
14/67 • Number of events 17 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
|
Psychiatric disorders
Psychological
|
35.2%
25/71 • Number of events 40 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
34.8%
24/69 • Number of events 36 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
22.4%
15/67 • Number of events 25 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
14.1%
10/71 • Number of events 12 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
14.5%
10/69 • Number of events 18 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
11.9%
8/67 • Number of events 10 • 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place