Trial Outcomes & Findings for Vortioxetine for Posttraumatic Stress Disorder (NCT NCT02637895)
NCT ID: NCT02637895
Last Updated: 2021-02-08
Results Overview
Clinician-Administered PTSD Scale (CAPS-5) has a total score ranging from 0-80 with the higher score indicating greater degree of PTSD symptom severity.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
41 participants
Primary outcome timeframe
Baseline, Up to Week 12
Results posted on
2021-02-08
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo pill once daily for 12 weeks of active treatment.
Placebo: Placebo pill matching Vortioxetine.
|
Vortioxetine
Vortioxetine pill 10mg once daily up to 4 weeks followed by 20mg once daily if tolerated for the rest of the study. Patients unable to tolerate the 20 mg/day dose may be reduced to 10 mg/day between weeks 4 and 8. The dose of study medication should remain stable for weeks 8-12.
Vortioxetine: Vortioxetine pill 10mg once daily up to 4 weeks followed by 20mg once daily if tolerated for the rest of the study. Patients unable to tolerate the 20 mg/day dose may be reduced to 10 mg/day between weeks 4 and 8. The dose of study medication should remain stable for weeks 8-12.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
|
Overall Study
COMPLETED
|
15
|
17
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
Placebo
Placebo pill once daily for 12 weeks of active treatment.
Placebo: Placebo pill matching Vortioxetine.
|
Vortioxetine
Vortioxetine pill 10mg once daily up to 4 weeks followed by 20mg once daily if tolerated for the rest of the study. Patients unable to tolerate the 20 mg/day dose may be reduced to 10 mg/day between weeks 4 and 8. The dose of study medication should remain stable for weeks 8-12.
Vortioxetine: Vortioxetine pill 10mg once daily up to 4 weeks followed by 20mg once daily if tolerated for the rest of the study. Patients unable to tolerate the 20 mg/day dose may be reduced to 10 mg/day between weeks 4 and 8. The dose of study medication should remain stable for weeks 8-12.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Abnormal baseline lab
|
0
|
1
|
Baseline Characteristics
Vortioxetine for Posttraumatic Stress Disorder
Baseline characteristics by cohort
| Measure |
Placebo
n=21 Participants
Placebo pill once daily for 12 weeks of active treatment.
Placebo: Placebo pill matching Vortioxetine.
|
Vortioxetine
n=20 Participants
Vortioxetine pill 10mg once daily up to 4 weeks followed by 20mg once daily if tolerated for the rest of the study. Patients unable to tolerate the 20 mg/day dose may be reduced to 10 mg/day between weeks 4 and 8. The dose of study medication should remain stable for weeks 8-12.
Vortioxetine: Vortioxetine pill 10mg once daily up to 4 weeks followed by 20mg once daily if tolerated for the rest of the study. Patients unable to tolerate the 20 mg/day dose may be reduced to 10 mg/day between weeks 4 and 8. The dose of study medication should remain stable for weeks 8-12.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.1 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
44.3 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
42.2 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Up to Week 12Population: Mixed Model Repeated Measures (MMRM) Analysis of all Intent To Treat (ITT) cases
Clinician-Administered PTSD Scale (CAPS-5) has a total score ranging from 0-80 with the higher score indicating greater degree of PTSD symptom severity.
Outcome measures
| Measure |
Placebo
n=21 Participants
Placebo pill once daily for 12 weeks of active treatment.
Placebo: Placebo pill matching Vortioxetine.
|
Vortioxetine
n=20 Participants
Vortioxetine pill 10mg once daily up to 4 weeks followed by 20mg once daily if tolerated for the rest of the study. Patients unable to tolerate the 20 mg/day dose may be reduced to 10 mg/day between weeks 4 and 8. The dose of study medication should remain stable for weeks 8-12.
Vortioxetine: Vortioxetine pill 10mg once daily up to 4 weeks followed by 20mg once daily if tolerated for the rest of the study. Patients unable to tolerate the 20 mg/day dose may be reduced to 10 mg/day between weeks 4 and 8. The dose of study medication should remain stable for weeks 8-12.
|
|---|---|---|
|
Change Clinician Administered PTSD Scale Score
|
16 score on a scale
Standard Error 3.00
|
17 score on a scale
Standard Error 2.70
|
SECONDARY outcome
Timeframe: Week 12Number of participants that achieve treatment response will be reported as those that has achieved a 30% improvement in their CAPS-5 total score from baseline. CAPS-5 has a total score ranging from 0-80 with the higher score indicating greater degree of PTSD symptom severity. Observed cases only.
Outcome measures
| Measure |
Placebo
n=15 Participants
Placebo pill once daily for 12 weeks of active treatment.
Placebo: Placebo pill matching Vortioxetine.
|
Vortioxetine
n=17 Participants
Vortioxetine pill 10mg once daily up to 4 weeks followed by 20mg once daily if tolerated for the rest of the study. Patients unable to tolerate the 20 mg/day dose may be reduced to 10 mg/day between weeks 4 and 8. The dose of study medication should remain stable for weeks 8-12.
Vortioxetine: Vortioxetine pill 10mg once daily up to 4 weeks followed by 20mg once daily if tolerated for the rest of the study. Patients unable to tolerate the 20 mg/day dose may be reduced to 10 mg/day between weeks 4 and 8. The dose of study medication should remain stable for weeks 8-12.
|
|---|---|---|
|
Number of Participants That Achieve Treatment Response Via Clinician Administered PTSD Scale (CAPS)-5
|
9 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Baseline, Up to Week 12Population: Mixed Model Repeated Measures (MMRM) Analysis of all Intent To Treat (ITT) cases
Montgomery-Asberg Depression Rating Scale (MADRS) has a total score ranging from 0-60, with 0 meaning no depressive symptoms and 60 meaning severe depressive symptoms.(MADRS). From the total score 0-60, with 0 meaning no depressive symptoms and 60 meaning severe depressive symptoms.
Outcome measures
| Measure |
Placebo
n=21 Participants
Placebo pill once daily for 12 weeks of active treatment.
Placebo: Placebo pill matching Vortioxetine.
|
Vortioxetine
n=20 Participants
Vortioxetine pill 10mg once daily up to 4 weeks followed by 20mg once daily if tolerated for the rest of the study. Patients unable to tolerate the 20 mg/day dose may be reduced to 10 mg/day between weeks 4 and 8. The dose of study medication should remain stable for weeks 8-12.
Vortioxetine: Vortioxetine pill 10mg once daily up to 4 weeks followed by 20mg once daily if tolerated for the rest of the study. Patients unable to tolerate the 20 mg/day dose may be reduced to 10 mg/day between weeks 4 and 8. The dose of study medication should remain stable for weeks 8-12.
|
|---|---|---|
|
Change in Depressive Symptoms in PTSD
|
9.73 score on a scale
Standard Error 1.95
|
12.06 score on a scale
Standard Error 2.27
|
SECONDARY outcome
Timeframe: Week 12Clinical Global Impression of Improvement (CGI-I) is a 7 point Likert-scale questionnaire assessing PTSD symptoms improvement. A score of 1 indicates very much improved, 4 indicates no change and 7 indicates much worse. Treatment response will be reported as the number of participants with an improvement of 1-2 points on their CGI-I score from baseline. Analysis includes observed cases only.
Outcome measures
| Measure |
Placebo
n=15 Participants
Placebo pill once daily for 12 weeks of active treatment.
Placebo: Placebo pill matching Vortioxetine.
|
Vortioxetine
n=17 Participants
Vortioxetine pill 10mg once daily up to 4 weeks followed by 20mg once daily if tolerated for the rest of the study. Patients unable to tolerate the 20 mg/day dose may be reduced to 10 mg/day between weeks 4 and 8. The dose of study medication should remain stable for weeks 8-12.
Vortioxetine: Vortioxetine pill 10mg once daily up to 4 weeks followed by 20mg once daily if tolerated for the rest of the study. Patients unable to tolerate the 20 mg/day dose may be reduced to 10 mg/day between weeks 4 and 8. The dose of study medication should remain stable for weeks 8-12.
|
|---|---|---|
|
Number of Participants That Achieve Treatment Response Via CGI-I
|
10 Participants
|
11 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Vortioxetine
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=21 participants at risk
Placebo pill once daily for 12 weeks of active treatment.
Placebo: Placebo pill matching Vortioxetine.
|
Vortioxetine
n=20 participants at risk
Vortioxetine pill 10mg once daily up to 4 weeks followed by 20mg once daily if tolerated for the rest of the study. Patients unable to tolerate the 20 mg/day dose may be reduced to 10 mg/day between weeks 4 and 8. The dose of study medication should remain stable for weeks 8-12.
Vortioxetine: Vortioxetine pill 10mg once daily up to 4 weeks followed by 20mg once daily if tolerated for the rest of the study. Patients unable to tolerate the 20 mg/day dose may be reduced to 10 mg/day between weeks 4 and 8. The dose of study medication should remain stable for weeks 8-12.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
19.0%
4/21 • Number of events 10 • 16 weeks
Only treatment-related adverse events, as evaluated by treating physician, will be reported at the 5% reporting threshold.
|
15.0%
3/20 • Number of events 4 • 16 weeks
Only treatment-related adverse events, as evaluated by treating physician, will be reported at the 5% reporting threshold.
|
|
Gastrointestinal disorders
Constipation
|
9.5%
2/21 • Number of events 3 • 16 weeks
Only treatment-related adverse events, as evaluated by treating physician, will be reported at the 5% reporting threshold.
|
20.0%
4/20 • Number of events 5 • 16 weeks
Only treatment-related adverse events, as evaluated by treating physician, will be reported at the 5% reporting threshold.
|
|
Gastrointestinal disorders
Nausea
|
19.0%
4/21 • Number of events 6 • 16 weeks
Only treatment-related adverse events, as evaluated by treating physician, will be reported at the 5% reporting threshold.
|
50.0%
10/20 • Number of events 16 • 16 weeks
Only treatment-related adverse events, as evaluated by treating physician, will be reported at the 5% reporting threshold.
|
|
General disorders
Headache
|
19.0%
4/21 • Number of events 11 • 16 weeks
Only treatment-related adverse events, as evaluated by treating physician, will be reported at the 5% reporting threshold.
|
30.0%
6/20 • Number of events 10 • 16 weeks
Only treatment-related adverse events, as evaluated by treating physician, will be reported at the 5% reporting threshold.
|
Additional Information
Dr. Philip Harvey
University of Miami Miller School of Medicine
Phone: 305 243 4094
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place