Trial Outcomes & Findings for Combination Treatment for Posttraumatic Stress Disorder (PTSD) After the World Trade Center (WTC) Attack (NCT NCT01130103)
NCT ID: NCT01130103
Last Updated: 2012-12-04
Results Overview
PTSD severity, minimum = 0 = no symptoms of PTSD maximum = 136 = extremely severe symptoms of PTSD
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
37 participants
Primary outcome timeframe
Weeks 0,5,10
Results posted on
2012-12-04
Participant Flow
Recruitment dates: December, 2004 to February, 2009. Location: Anxiety Disorders research clinic.
Participant milestones
| Measure |
Paroxetine
Paroxetine and Prolonged Exposure Therapy
|
Placebo Pill
Placebo pill plus Prolonged Exposure Therapy
|
|---|---|---|
|
Randomized Treatment
STARTED
|
19
|
18
|
|
Randomized Treatment
COMPLETED
|
13
|
13
|
|
Randomized Treatment
NOT COMPLETED
|
6
|
5
|
|
Maintenance Treatment
STARTED
|
13
|
13
|
|
Maintenance Treatment
COMPLETED
|
11
|
11
|
|
Maintenance Treatment
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Paroxetine
Paroxetine and Prolonged Exposure Therapy
|
Placebo Pill
Placebo pill plus Prolonged Exposure Therapy
|
|---|---|---|
|
Randomized Treatment
Adverse Event
|
1
|
1
|
|
Randomized Treatment
Lost to Follow-up
|
1
|
0
|
|
Randomized Treatment
Protocol Violation
|
3
|
2
|
|
Randomized Treatment
Withdrawal by Subject
|
1
|
2
|
|
Maintenance Treatment
Lack of Efficacy
|
0
|
1
|
|
Maintenance Treatment
Lost to Follow-up
|
1
|
1
|
|
Maintenance Treatment
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Combination Treatment for Posttraumatic Stress Disorder (PTSD) After the World Trade Center (WTC) Attack
Baseline characteristics by cohort
| Measure |
Paroxetine
n=19 Participants
Paroxetine and Prolonged Exposure Therapy
|
Placebo Pill
n=18 Participants
Placebo pill plus Prolonged Exposure Therapy
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
18 participants
n=7 Participants
|
37 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 0,5,10Population: all participants who were randomized
PTSD severity, minimum = 0 = no symptoms of PTSD maximum = 136 = extremely severe symptoms of PTSD
Outcome measures
| Measure |
Paroxetine
n=19 Participants
Paroxetine and Prolonged Exposure Therapy
|
Placebo Pill
n=18 Participants
Placebo pill plus Prolonged Exposure Therapy
|
|---|---|---|
|
Clinician Administered PTSD Scale (CAPS)
week 0
|
72.6 units on a scale
Standard Deviation 12.9
|
65.4 units on a scale
Standard Deviation 12.8
|
|
Clinician Administered PTSD Scale (CAPS)
week 5
|
40.7 units on a scale
Standard Deviation 28.4
|
49.0 units on a scale
Standard Deviation 23.9
|
|
Clinician Administered PTSD Scale (CAPS)
week 10
|
21.5 units on a scale
Standard Deviation 19.9
|
35.6 units on a scale
Standard Deviation 31.3
|
PRIMARY outcome
Timeframe: Weeks 5,10Population: all participants who were randomized, with people who dropped out counted as non-remitters
remission defined as: CAPS less than or equal to 20 and Clinical Global Impression (CGI)-change score=1
Outcome measures
| Measure |
Paroxetine
n=19 Participants
Paroxetine and Prolonged Exposure Therapy
|
Placebo Pill
n=18 Participants
Placebo pill plus Prolonged Exposure Therapy
|
|---|---|---|
|
Number of Participants Who Met Remission Criterion
week 5
|
2 participants
|
0 participants
|
|
Number of Participants Who Met Remission Criterion
week 10
|
8 participants
|
3 participants
|
SECONDARY outcome
Timeframe: weeks 5,10Population: all subjects randomized with dropouts carried forward as nonresponders
responder status: CGI-change score of 1 or 2 1=very much improved, 2= much improved
Outcome measures
| Measure |
Paroxetine
n=19 Participants
Paroxetine and Prolonged Exposure Therapy
|
Placebo Pill
n=18 Participants
Placebo pill plus Prolonged Exposure Therapy
|
|---|---|---|
|
Treatment Response at Weeks 5 and 10
week 5
|
6 participants
|
6 participants
|
|
Treatment Response at Weeks 5 and 10
week 10
|
12 participants
|
7 participants
|
SECONDARY outcome
Timeframe: weeks 0,5,10Population: observed data at each time point
total score at weeks 0, 5, 10
Outcome measures
| Measure |
Paroxetine
n=19 Participants
Paroxetine and Prolonged Exposure Therapy
|
Placebo Pill
n=18 Participants
Placebo pill plus Prolonged Exposure Therapy
|
|---|---|---|
|
Hamilton Depression Scale 0 = no Depression Symptoms 40 = Extreme Depression Symptoms
week 0
|
16.9 units on a scale
Standard Deviation 4.9
|
16.6 units on a scale
Standard Deviation 4.9
|
|
Hamilton Depression Scale 0 = no Depression Symptoms 40 = Extreme Depression Symptoms
week 5
|
11.7 units on a scale
Standard Deviation 5.9
|
11.8 units on a scale
Standard Deviation 5.6
|
|
Hamilton Depression Scale 0 = no Depression Symptoms 40 = Extreme Depression Symptoms
week 10
|
7.7 units on a scale
Standard Deviation 3.7
|
11.4 units on a scale
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: weeks 0,5,10Population: observed data at weeks 0, 5, and 10
Measures life enjoyment and satisfaction across 16 domains 16 = very poor quality of life to 80 =very good quality of life
Outcome measures
| Measure |
Paroxetine
n=16 Participants
Paroxetine and Prolonged Exposure Therapy
|
Placebo Pill
n=16 Participants
Placebo pill plus Prolonged Exposure Therapy
|
|---|---|---|
|
Quality of Life Enjoyment and Satisfaction Scale Total Score at Week 0,5,10
week 0
|
47.1 units on a scale
Standard Deviation 11.0
|
45.4 units on a scale
Standard Deviation 18.5
|
|
Quality of Life Enjoyment and Satisfaction Scale Total Score at Week 0,5,10
week 5
|
55.5 units on a scale
Standard Deviation 13.4
|
59.4 units on a scale
Standard Deviation 17.6
|
|
Quality of Life Enjoyment and Satisfaction Scale Total Score at Week 0,5,10
week 10
|
67.9 units on a scale
Standard Deviation 12.7
|
54.8 units on a scale
Standard Deviation 22.3
|
Adverse Events
Paroxetine
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo Pill
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Paroxetine
n=19 participants at risk
Paroxetine and Prolonged Exposure Therapy
|
Placebo Pill
n=18 participants at risk
Placebo pill plus Prolonged Exposure Therapy
|
|---|---|---|
|
Nervous system disorders
headache
|
10.5%
2/19 • Number of events 2
|
11.1%
2/18 • Number of events 2
|
|
Cardiac disorders
palpitations
|
10.5%
2/19 • Number of events 2
|
11.1%
2/18 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
31.6%
6/19 • Number of events 6
|
27.8%
5/18 • Number of events 5
|
|
Gastrointestinal disorders
nausea
|
26.3%
5/19 • Number of events 5
|
16.7%
3/18 • Number of events 3
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/19
|
16.7%
3/18 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
sweating
|
15.8%
3/19 • Number of events 3
|
16.7%
3/18 • Number of events 3
|
|
Eye disorders
photophobia
|
10.5%
2/19 • Number of events 2
|
5.6%
1/18 • Number of events 1
|
|
Cardiac disorders
tachycardia
|
5.3%
1/19 • Number of events 1
|
11.1%
2/18 • Number of events 2
|
|
Gastrointestinal disorders
constipation
|
21.1%
4/19 • Number of events 4
|
11.1%
2/18 • Number of events 2
|
|
Gastrointestinal disorders
diarrhea
|
26.3%
5/19 • Number of events 5
|
11.1%
2/18 • Number of events 2
|
|
Nervous system disorders
lightheadedness
|
5.3%
1/19 • Number of events 1
|
16.7%
3/18 • Number of events 3
|
|
Gastrointestinal disorders
dry mouth
|
15.8%
3/19 • Number of events 3
|
11.1%
2/18 • Number of events 2
|
|
Eye disorders
blurry vision
|
15.8%
3/19 • Number of events 3
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
parasthesias
|
5.3%
1/19 • Number of events 1
|
16.7%
3/18 • Number of events 3
|
|
Reproductive system and breast disorders
decrease libido
|
21.1%
4/19 • Number of events 4
|
0.00%
0/18
|
|
Reproductive system and breast disorders
anorgasmia
|
15.8%
3/19 • Number of events 3
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
impaired coordination
|
15.8%
3/19 • Number of events 3
|
11.1%
2/18 • Number of events 2
|
|
Nervous system disorders
nervousness
|
15.8%
3/19 • Number of events 3
|
5.6%
1/18 • Number of events 1
|
|
General disorders
fatigue
|
15.8%
3/19 • Number of events 3
|
16.7%
3/18 • Number of events 3
|
|
Nervous system disorders
insomnia
|
5.3%
1/19 • Number of events 1
|
11.1%
2/18 • Number of events 2
|
|
General disorders
weight gain
|
10.5%
2/19 • Number of events 2
|
5.6%
1/18 • Number of events 1
|
|
General disorders
weight loss
|
10.5%
2/19 • Number of events 2
|
16.7%
3/18 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
skin problems
|
10.5%
2/19 • Number of events 2
|
5.6%
1/18 • Number of events 1
|
|
Renal and urinary disorders
difficulty urinating
|
10.5%
2/19 • Number of events 2
|
22.2%
4/18 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
rigidity
|
10.5%
2/19 • Number of events 2
|
5.6%
1/18 • Number of events 1
|
|
General disorders
somnolence
|
10.5%
2/19 • Number of events 2
|
16.7%
3/18 • Number of events 3
|
Additional Information
Franklin Schneier MD
Research Foundation for Mental Hygiene
Phone: 212-543-5368
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place