Trial Outcomes & Findings for Combined Mirtazapine and SSRI Treatment of PTSD: A Placebo-Controlled Trial (NCT NCT01178671)
NCT ID: NCT01178671
Last Updated: 2016-04-08
Results Overview
PTSD severity will be measured by the Clinician-Administered Posttraumatic Stress Disorder Scale, from 0 (least severe) to 136 (most severe).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
38 participants
Primary outcome timeframe
up to 24 weeks
Results posted on
2016-04-08
Participant Flow
Participant milestones
| Measure |
Sertraline and Mirtazapine
Flexible dose of both medications for up to 24 weeks
Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
|
Sertraline and Sugar Pill
Sertraline and Sugar pill for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
6
|
3
|
|
Overall Study
NOT COMPLETED
|
12
|
15
|
Reasons for withdrawal
| Measure |
Sertraline and Mirtazapine
Flexible dose of both medications for up to 24 weeks
Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
|
Sertraline and Sugar Pill
Sertraline and Sugar pill for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
6
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Physician Decision
|
4
|
6
|
Baseline Characteristics
Combined Mirtazapine and SSRI Treatment of PTSD: A Placebo-Controlled Trial
Baseline characteristics by cohort
| Measure |
Sertraline and Mirtazapine
n=18 Participants
Flexible dose of both medications for up to 24 weeks
Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
|
Sertraline and Sugar Pill
n=18 Participants
Sertraline and Sugar pill for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
37.6 years
STANDARD_DEVIATION 11.7 • n=93 Participants
|
42.4 years
STANDARD_DEVIATION 13.3 • n=4 Participants
|
40.0 years
STANDARD_DEVIATION 12.5 • n=27 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
white
|
4 participants
n=93 Participants
|
5 participants
n=4 Participants
|
9 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
black
|
4 participants
n=93 Participants
|
3 participants
n=4 Participants
|
7 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
other
|
10 participants
n=93 Participants
|
10 participants
n=4 Participants
|
20 participants
n=27 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=93 Participants
|
18 participants
n=4 Participants
|
36 participants
n=27 Participants
|
|
Hamilton Rating Scale for Depression
|
20.8 units on a scale
STANDARD_DEVIATION 6.2 • n=93 Participants
|
20.4 units on a scale
STANDARD_DEVIATION 5.9 • n=4 Participants
|
20.6 units on a scale
STANDARD_DEVIATION 6.0 • n=27 Participants
|
|
Posttraumatic Stress Disorder Checklist
|
58.9 units on a scale
STANDARD_DEVIATION 11.0 • n=93 Participants
|
60.0 units on a scale
STANDARD_DEVIATION 10.5 • n=4 Participants
|
59.5 units on a scale
STANDARD_DEVIATION 10.8 • n=27 Participants
|
|
Quality of Life Enjoyment and Satisfaction Scale
|
39.1 units on a scale
STANDARD_DEVIATION 13.6 • n=93 Participants
|
41.4 units on a scale
STANDARD_DEVIATION 13.5 • n=4 Participants
|
40.2 units on a scale
STANDARD_DEVIATION 13.4 • n=27 Participants
|
|
Medical Outcomes Study Short Form 12 - Physical
|
43.9 units on a scale
STANDARD_DEVIATION 9.8 • n=93 Participants
|
41.4 units on a scale
STANDARD_DEVIATION 10.6 • n=4 Participants
|
42.7 units on a scale
STANDARD_DEVIATION 10.1 • n=27 Participants
|
|
Medical Outcomes Study Short Form 12 - Mental
|
30.3 units on a scale
STANDARD_DEVIATION 13.5 • n=93 Participants
|
30.4 units on a scale
STANDARD_DEVIATION 10.0 • n=4 Participants
|
30.4 units on a scale
STANDARD_DEVIATION 11.7 • n=27 Participants
|
|
Pittsburgh Sleep Quality Index Global
|
11.5 units on a scale
STANDARD_DEVIATION 4.9 • n=93 Participants
|
12.8 units on a scale
STANDARD_DEVIATION 3.1 • n=4 Participants
|
12.1 units on a scale
STANDARD_DEVIATION 4.1 • n=27 Participants
|
|
Pittsburgh Sleep Quality Index Addendum for PTSD
|
10.0 units on a scale
STANDARD_DEVIATION 4.9 • n=93 Participants
|
11.2 units on a scale
STANDARD_DEVIATION 5.6 • n=4 Participants
|
10.6 units on a scale
STANDARD_DEVIATION 5.2 • n=27 Participants
|
|
Clinician Administered PTSD Scale
|
77.9 units on a scale
STANDARD_DEVIATION 19.5 • n=93 Participants
|
81.3 units on a scale
STANDARD_DEVIATION 12.2 • n=4 Participants
|
79.6 units on a scale
STANDARD_DEVIATION 16.2 • n=27 Participants
|
PRIMARY outcome
Timeframe: up to 24 weeksPopulation: intention to treat sample
PTSD severity will be measured by the Clinician-Administered Posttraumatic Stress Disorder Scale, from 0 (least severe) to 136 (most severe).
Outcome measures
| Measure |
Sertraline and Sugar Pill
n=18 Participants
Sertraline and Sugar pill for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks
|
Sertraline and Mirtazapine
n=18 Participants
Flexible dose of both medications for up to 24 weeks
Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
|
|---|---|---|
|
PTSD Severity
|
34.6 units on a scale
Standard Deviation 17.7
|
23.8 units on a scale
Standard Deviation 17.4
|
PRIMARY outcome
Timeframe: up to 24 weeksOutcome measures
| Measure |
Sertraline and Sugar Pill
n=18 Participants
Sertraline and Sugar pill for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks
|
Sertraline and Mirtazapine
n=18 Participants
Flexible dose of both medications for up to 24 weeks
Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
|
|---|---|---|
|
Time to Discontinuation of Study Treatment
|
90.0 days
Standard Deviation 14.8
|
95.2 days
Standard Deviation 73.1
|
SECONDARY outcome
Timeframe: up to 24 weeksPopulation: completers
as measured by the Short Posttraumatic Stress Disorder Rating Interview, which rates severity of PTSD from 0 (least severe) to 32 (most severe)
Outcome measures
| Measure |
Sertraline and Sugar Pill
n=6 Participants
Sertraline and Sugar pill for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks
|
Sertraline and Mirtazapine
n=9 Participants
Flexible dose of both medications for up to 24 weeks
Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
|
|---|---|---|
|
Alternative Measure of PTSD Severity
|
6.7 units on a scale
Standard Deviation 5.0
|
3.4 units on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: up to 24 weeksPopulation: completers
as measured by the PTSD Checklist which rates severity of PTSD from 17 (least severe) to 85 (most severe).
Outcome measures
| Measure |
Sertraline and Sugar Pill
n=9 Participants
Sertraline and Sugar pill for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks
|
Sertraline and Mirtazapine
n=9 Participants
Flexible dose of both medications for up to 24 weeks
Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
|
|---|---|---|
|
PTSD Self-rated Severity
|
39.2 units on a scale
Standard Deviation 18.2
|
33.2 units on a scale
Standard Deviation 18.4
|
SECONDARY outcome
Timeframe: up to 24 weeksPopulation: intent to treat
as measured by the 17-item Hamilton Rating Scale for Depression, which rates severity of depression on a scale from 0 (least depression) to 50 (greatest depression).
Outcome measures
| Measure |
Sertraline and Sugar Pill
n=18 Participants
Sertraline and Sugar pill for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks
|
Sertraline and Mirtazapine
n=18 Participants
Flexible dose of both medications for up to 24 weeks
Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
|
|---|---|---|
|
Depression Severity
|
11.6 units on a scale
Standard Deviation 6.4
|
6.4 units on a scale
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: up to 24 weeksPopulation: intent to treat
Responders defined by Clinician Administered Posttraumatic Stress Disorder Scale total score decreased by at least 30% compared with baseline and Clinical Global Impression improvement score of =1 or 2 at endpoint
Outcome measures
| Measure |
Sertraline and Sugar Pill
n=18 Participants
Sertraline and Sugar pill for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks
|
Sertraline and Mirtazapine
n=18 Participants
Flexible dose of both medications for up to 24 weeks
Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
|
|---|---|---|
|
Response Status
|
22 percentage of subjects
|
56 percentage of subjects
|
SECONDARY outcome
Timeframe: up to 24 weeksPopulation: intent to treat
Remitter as defined by Clinician Administered Posttraumatic Stress Disorders Scale total score \<20 at endpoint
Outcome measures
| Measure |
Sertraline and Sugar Pill
n=18 Participants
Sertraline and Sugar pill for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks
|
Sertraline and Mirtazapine
n=18 Participants
Flexible dose of both medications for up to 24 weeks
Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
|
|---|---|---|
|
Remission Status
|
11 percentage of subjects
|
39 percentage of subjects
|
SECONDARY outcome
Timeframe: up to 24 weeksPopulation: intent to treat
as assessed by Side Effect Checklist
Outcome measures
| Measure |
Sertraline and Sugar Pill
n=18 Participants
Sertraline and Sugar pill for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks
|
Sertraline and Mirtazapine
n=18 Participants
Flexible dose of both medications for up to 24 weeks
Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
|
|---|---|---|
|
Adverse Effects
|
33.3 percentage of subject dropped due to AEs
|
22.2 percentage of subject dropped due to AEs
|
SECONDARY outcome
Timeframe: up to 24 weeksPopulation: intent to treat
as measured by Pittsburgh Sleep Quality Index, which rates severity of impairment in sleep quality from 0 (least impaired) to 21 (most impaired).
Outcome measures
| Measure |
Sertraline and Sugar Pill
n=18 Participants
Sertraline and Sugar pill for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks
|
Sertraline and Mirtazapine
n=18 Participants
Flexible dose of both medications for up to 24 weeks
Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
|
|---|---|---|
|
Sleep Quality
|
9.1 units on a scale
Standard Deviation 4.9
|
4.4 units on a scale
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: up to 24 weeksPopulation: intent to treat
as measured by Arizona Sexual Experiences Scale, which rates impairment in sexual functioning from 5 (least impaired) to 30 (most impaired).
Outcome measures
| Measure |
Sertraline and Sugar Pill
n=18 Participants
Sertraline and Sugar pill for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks
|
Sertraline and Mirtazapine
n=18 Participants
Flexible dose of both medications for up to 24 weeks
Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
|
|---|---|---|
|
Sexual Functioning
|
17.4 units on a scale
Standard Deviation 8.1
|
16.3 units on a scale
Standard Deviation 4.3
|
Adverse Events
Sertraline and Mirtazapine
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Sertraline and Sugar Pill
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sertraline and Mirtazapine
n=18 participants at risk
Flexible dose of both medications for up to 24 weeks
Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
|
Sertraline and Sugar Pill
n=18 participants at risk
Sertraline and Sugar pill for up to 24 weeks
Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks
|
|---|---|---|
|
Nervous system disorders
headache
|
22.2%
4/18 • 24 weeks
|
16.7%
3/18 • 24 weeks
|
|
Gastrointestinal disorders
heartburn
|
27.8%
5/18 • 24 weeks
|
16.7%
3/18 • 24 weeks
|
|
Gastrointestinal disorders
nausea
|
11.1%
2/18 • 24 weeks
|
44.4%
8/18 • 24 weeks
|
|
Gastrointestinal disorders
emesis
|
11.1%
2/18 • 24 weeks
|
16.7%
3/18 • 24 weeks
|
|
Gastrointestinal disorders
decreased appetite
|
16.7%
3/18 • 24 weeks
|
27.8%
5/18 • 24 weeks
|
|
Gastrointestinal disorders
increased appetite
|
50.0%
9/18 • 24 weeks
|
11.1%
2/18 • 24 weeks
|
|
Gastrointestinal disorders
dry mouth
|
16.7%
3/18 • 24 weeks
|
27.8%
5/18 • 24 weeks
|
|
Gastrointestinal disorders
constipation
|
16.7%
3/18 • 24 weeks
|
27.8%
5/18 • 24 weeks
|
|
Gastrointestinal disorders
diarrhea
|
33.3%
6/18 • 24 weeks
|
27.8%
5/18 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
sweating
|
22.2%
4/18 • 24 weeks
|
27.8%
5/18 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
skin problems
|
22.2%
4/18 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
|
Blood and lymphatic system disorders
bruising
|
0.00%
0/18 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
|
Nervous system disorders
restlessness
|
11.1%
2/18 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
|
Nervous system disorders
tremor
|
27.8%
5/18 • 24 weeks
|
27.8%
5/18 • 24 weeks
|
|
Nervous system disorders
nervousness
|
5.6%
1/18 • 24 weeks
|
5.6%
1/18 • 24 weeks
|
|
Nervous system disorders
incoordination
|
16.7%
3/18 • 24 weeks
|
11.1%
2/18 • 24 weeks
|
|
Nervous system disorders
insomnia
|
11.1%
2/18 • 24 weeks
|
11.1%
2/18 • 24 weeks
|
|
General disorders
fatigue
|
5.6%
1/18 • 24 weeks
|
33.3%
6/18 • 24 weeks
|
|
Nervous system disorders
somnolence
|
33.3%
6/18 • 24 weeks
|
27.8%
5/18 • 24 weeks
|
|
Reproductive system and breast disorders
decreased libido (men)
|
0.00%
0/6 • 24 weeks
|
42.9%
3/7 • 24 weeks
|
|
Reproductive system and breast disorders
decreased libido (women)
|
41.7%
5/12 • 24 weeks
|
27.3%
3/11 • 24 weeks
|
|
Reproductive system and breast disorders
sexual dysfunction (men)
|
0.00%
0/6 • 24 weeks
|
42.9%
3/7 • 24 weeks
|
|
Reproductive system and breast disorders
sexual dysfunction (women)
|
8.3%
1/12 • 24 weeks
|
18.2%
2/11 • 24 weeks
|
|
Renal and urinary disorders
urinary dysfunction
|
27.8%
5/18 • 24 weeks
|
27.8%
5/18 • 24 weeks
|
|
Eye disorders
blurry vision
|
22.2%
4/18 • 24 weeks
|
11.1%
2/18 • 24 weeks
|
|
Nervous system disorders
lightheadedness
|
50.0%
9/18 • 24 weeks
|
22.2%
4/18 • 24 weeks
|
|
Nervous system disorders
forgetfulness
|
22.2%
4/18 • 24 weeks
|
22.2%
4/18 • 24 weeks
|
|
Nervous system disorders
impaired concentration
|
11.1%
2/18 • 24 weeks
|
22.2%
4/18 • 24 weeks
|
|
Nervous system disorders
apathy
|
11.1%
2/18 • 24 weeks
|
16.7%
3/18 • 24 weeks
|
Additional Information
Franklin Schneier MD
Research Foundation for Mental Hygiene
Phone: 6467748041
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place