Trial Outcomes & Findings for 12-Week Study of Pristiq (Desvenlafaxine) Social Anxiety Disorder (NCT NCT01316302)
NCT ID: NCT01316302
Last Updated: 2016-10-17
Results Overview
Liebowitz Social Anxiety Scale, measuring social anxiety symptoms; possible total scores ranging from 0-144, with higher scores indicating greater severity of symptoms.
COMPLETED
PHASE4
63 participants
Baseline to study endpoint (Week 12)
2016-10-17
Participant Flow
Participant milestones
| Measure |
Pristiq
Flexible dose, 50-100mg QD
Pristiq: Flexible dose, 50-100mg QD, for 12 weeks.
|
Placebo
Matching placebo
Placebo: Matching placebo, taken QD for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
33
|
|
Overall Study
COMPLETED
|
20
|
22
|
|
Overall Study
NOT COMPLETED
|
10
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
12-Week Study of Pristiq (Desvenlafaxine) Social Anxiety Disorder
Baseline characteristics by cohort
| Measure |
Pristiq
n=30 Participants
Flexible dose, 50-100mg QD
Pristiq: Flexible dose, 50-100mg QD, for 12 weeks.
|
Placebo
n=33 Participants
Matching placebo
Placebo: Matching placebo, taken QD for 12 weeks.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.9 years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
41.9 years
STANDARD_DEVIATION 13.7 • n=7 Participants
|
40.0 years
STANDARD_DEVIATION 19.9 • n=5 Participants
|
|
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
|
30 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
63 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
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
33 participants
n=7 Participants
|
63 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to study endpoint (Week 12)Population: The number of participants for analysis was 29 subjects per arm; data analyzed at Week 12 or Last Observation Carried Forward for the 16 subjects who dropped out before completion. Five other randomized subjects (1 on drug, 4 on placebo) were excluded from the ITT sample because of insufficient data (n = 4) or poor compliance (n = 1).
Liebowitz Social Anxiety Scale, measuring social anxiety symptoms; possible total scores ranging from 0-144, with higher scores indicating greater severity of symptoms.
Outcome measures
| Measure |
Pristiq
n=29 Participants
Flexible dose, 50-100mg QD
Pristiq: Flexible dose, 50-100mg QD, for 12 weeks.
|
Placebo
n=29 Participants
Matching placebo
Placebo: Matching placebo, taken QD for 12 weeks.
|
|---|---|---|
|
Change in the Liebowitz Social Anxiety Scale (LSAS) Total Score
Mean baseline LSAS total
|
93.4 Scores on a scale
Standard Deviation 17.1
|
92.1 Scores on a scale
Standard Deviation 16.8
|
|
Change in the Liebowitz Social Anxiety Scale (LSAS) Total Score
Endpoint LSAS total
|
55.0 Scores on a scale
Standard Deviation 27.4
|
63.4 Scores on a scale
Standard Deviation 22.1
|
|
Change in the Liebowitz Social Anxiety Scale (LSAS) Total Score
Mean LSAS change from baseline
|
38.4 Scores on a scale
Standard Deviation 28.8
|
28.7 Scores on a scale
Standard Deviation 24.2
|
SECONDARY outcome
Timeframe: Baseline to Week 12CGI-I: one item, measuring overall improvement of illness; possible scores range from 1-7, with lower scores representing greater improvement. CGI-I responders: defined as having a CGI-I scores of 1 or 2 at Week 12/study endpoint.
Outcome measures
| Measure |
Pristiq
n=29 Participants
Flexible dose, 50-100mg QD
Pristiq: Flexible dose, 50-100mg QD, for 12 weeks.
|
Placebo
n=29 Participants
Matching placebo
Placebo: Matching placebo, taken QD for 12 weeks.
|
|---|---|---|
|
Clinical Global Impression of Improvement Scale (CGI-I)
|
69 % of subjects who were CGI-I responders
|
48.3 % of subjects who were CGI-I responders
|
SECONDARY outcome
Timeframe: Baseline to study endpoint (Week 12)Subject-rated global outcome scale. Subjects who rated themselves as 1 (Very Much Improved) or 2 (Much Improved) on the PGIC were considered self-rated responders.
Outcome measures
| Measure |
Pristiq
n=29 Participants
Flexible dose, 50-100mg QD
Pristiq: Flexible dose, 50-100mg QD, for 12 weeks.
|
Placebo
n=29 Participants
Matching placebo
Placebo: Matching placebo, taken QD for 12 weeks.
|
|---|---|---|
|
Patient Global Impression of Change
|
44.8 percentage of self-rated responders
|
40.7 percentage of self-rated responders
|
Adverse Events
Pristiq
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pristiq
n=30 participants at risk
Flexible dose, 50-100mg QD
Pristiq: Flexible dose, 50-100mg QD, for 12 weeks.
|
Placebo
n=33 participants at risk
Matching placebo
Placebo: Matching placebo, taken QD for 12 weeks.
|
|---|---|---|
|
General disorders
dizziness/lightheadedness/feeling faint
|
36.7%
11/30 • Number of events 12 • 14 weeks
|
12.1%
4/33 • Number of events 6 • 14 weeks
|
|
General disorders
nausea/queasiness
|
36.7%
11/30 • Number of events 16 • 14 weeks
|
9.1%
3/33 • Number of events 3 • 14 weeks
|
|
General disorders
drowsiness
|
23.3%
7/30 • Number of events 9 • 14 weeks
|
6.1%
2/33 • Number of events 2 • 14 weeks
|
|
Nervous system disorders
insomnia
|
16.7%
5/30 • Number of events 8 • 14 weeks
|
12.1%
4/33 • Number of events 4 • 14 weeks
|
|
General disorders
headache
|
13.3%
4/30 • Number of events 6 • 14 weeks
|
15.2%
5/33 • Number of events 6 • 14 weeks
|
|
General disorders
fatigue
|
13.3%
4/30 • Number of events 4 • 14 weeks
|
12.1%
4/33 • Number of events 5 • 14 weeks
|
|
General disorders
decreased appetite
|
20.0%
6/30 • Number of events 7 • 14 weeks
|
3.0%
1/33 • Number of events 1 • 14 weeks
|
|
Gastrointestinal disorders
indigestion
|
13.3%
4/30 • Number of events 4 • 14 weeks
|
3.0%
1/33 • Number of events 2 • 14 weeks
|
|
General disorders
flu/flu symptoms
|
6.7%
2/30 • Number of events 2 • 14 weeks
|
9.1%
3/33 • Number of events 3 • 14 weeks
|
|
General disorders
soft stools/diarrhea
|
16.7%
5/30 • Number of events 5 • 14 weeks
|
0.00%
0/33 • 14 weeks
|
|
General disorders
dry mouth
|
10.0%
3/30 • Number of events 3 • 14 weeks
|
3.0%
1/33 • Number of events 1 • 14 weeks
|
Additional Information
Michael R. Liebowitz, M.D.
The Medical Research Network, LLC
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place