Trial Outcomes & Findings for Duloxetine for Social Anxiety Disorder: Prediction of Long Term Outcome (NCT NCT00114127)
NCT ID: NCT00114127
Last Updated: 2014-06-10
Results Overview
The Liebowitz Social Anxiety Scale (LSAS; Liebowitz, 1987) is a 24-item scale that provides separate scores for fear and avoidance in social and performance situations with higher scores representing increased social anxiety. The LSAS contains three total scores: 1) total fear score (0-72), 2) total avoidance score(0-72), 3) and total overall score (0-144). Suggested interpretations: 55-65 Moderate social phobia, 65-80 Marked social phobia, 80-95 Severe social phobia, Greater than 95 - Very severe social phobia.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
28 participants
Primary outcome timeframe
6 months
Results posted on
2014-06-10
Participant Flow
Treatment seeking outpatients aged 18 years and older with a primary diagnosis of Generalized Social Anxiety Disorder (GSAD) were recruited by media advertisement.
Of the 39 participants who completed Phase I of this study, 28 moved on to Phase II. 1 subject was lost to follow up between baseline and week 1.
Participant milestones
| Measure |
Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2)
Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 13 received 60mg duloxetine plus placebo for 18 additional weeks.
|
Duloxetine 120mg/Day for 18 Weeks (Phase 2)
Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 15 received 120mg duloxetine for 18 additional weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
15
|
|
Overall Study
COMPLETED
|
9
|
11
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2)
Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 13 received 60mg duloxetine plus placebo for 18 additional weeks.
|
Duloxetine 120mg/Day for 18 Weeks (Phase 2)
Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 15 received 120mg duloxetine for 18 additional weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
Baseline Characteristics
Duloxetine for Social Anxiety Disorder: Prediction of Long Term Outcome
Baseline characteristics by cohort
| Measure |
Duloxetine 60mg/Day + Placebo for 18 Weeks(Phase 2)
n=13 Participants
Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 13 received 60mg duloxetine plus placebo for 18 additional weeks.
|
Duloxetine 120mg/Day for 18 Weeks (Phase 2)
n=15 Participants
Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 15 received 120mg duloxetine for 18 additional weeks.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age Baseline
|
36.6 Years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
35.5 Years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
36 Years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Alaskan Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Educational status, college graduate
College Graduate
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Educational status, college graduate
Not College Graduate
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Duration of illness, mean years (SD)
|
27.6 Years
STANDARD_DEVIATION 17.0 • n=5 Participants
|
20.1 Years
STANDARD_DEVIATION 12.3 • n=7 Participants
|
23.7 Years
STANDARD_DEVIATION 14.9 • n=5 Participants
|
|
Age of onset, mean age
|
9.9 Years
STANDARD_DEVIATION 3.3 • n=5 Participants
|
13.9 Years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
12.0 Years
STANDARD_DEVIATION 6.46 • n=5 Participants
|
|
Current comorbidity, Major depressive disorder (MDD)
Comorbid MDD
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Current comorbidity, Major depressive disorder (MDD)
No Comorbid MDD
|
8 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Current comorbidity, Dysthymia
Comorbid Dysthymia
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Current comorbidity, Dysthymia
No Comorbid Dysthymia
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Current comorbidity, Panic Disorder (PD)
Comorbid PD
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Current comorbidity, Panic Disorder (PD)
No Comorbid PD
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Current comorbidity, Generalized anxiety disorder (GAD)
Comorbid GAD
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Current comorbidity, Generalized anxiety disorder (GAD)
No Comorbid GAD
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
At least one concurrent mood or anxiety disorder
Concurrent mood or anxiety disorder
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
At least one concurrent mood or anxiety disorder
No concurrent mood or anxiety disorders
|
6 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Lifetime depression
Lifetime depression
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Lifetime depression
No Lifetime depression
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Lifetime alcohol or substance abuse or dependence
Lifetime Alcohol/substance abuse/dependence
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Lifetime alcohol or substance abuse or dependence
No Lifetime Alcohol/substance abuse/dependence
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Liebowitz Social Anxiety Scale (LSAS)
|
75.2 LSAS Score
STANDARD_DEVIATION 6.90 • n=5 Participants
|
74.1 LSAS Score
STANDARD_DEVIATION 6.20 • n=7 Participants
|
74.6 LSAS Score
STANDARD_DEVIATION 4.52 • n=5 Participants
|
|
Clinical Global Impression-Severity (CGI-S)
|
5.10 CGI-S Score
STANDARD_DEVIATION 0.43 • n=5 Participants
|
4.93 CGI-S Score
STANDARD_DEVIATION 0.36 • n=7 Participants
|
5.00 CGI-S Score
STANDARD_DEVIATION 0.27 • n=5 Participants
|
|
Clinical Global Impression-Improvement (CGI-I)
|
3.25 CGI-I Score
STANDARD_DEVIATION 0.97 • n=5 Participants
|
3.36 CGI-I Score
STANDARD_DEVIATION 1.22 • n=7 Participants
|
3.31 CGI-I Score
STANDARD_DEVIATION 1.09 • n=5 Participants
|
|
Montgomery Asberg Depression Rating Scale (MADRS)
|
8.08 MADRS Score
STANDARD_DEVIATION 5.00 • n=5 Participants
|
10.3 MADRS Score
STANDARD_DEVIATION 7.79 • n=7 Participants
|
9.17 MADRS Score
STANDARD_DEVIATION 6.60 • n=5 Participants
|
|
Sheehan Disability Scale (SDS)
|
11.2 SDS Score
STANDARD_DEVIATION 6.06 • n=5 Participants
|
14.1 SDS Score
STANDARD_DEVIATION 5.52 • n=7 Participants
|
12.9 SDS Score
STANDARD_DEVIATION 5.71 • n=5 Participants
|
|
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
|
49.1 Q-LES-Q Score
STANDARD_DEVIATION 8.83 • n=5 Participants
|
46.2 Q-LES-Q Score
STANDARD_DEVIATION 9.47 • n=7 Participants
|
47.5 Q-LES-Q Score
STANDARD_DEVIATION 9.12 • n=5 Participants
|
|
Liebowitz Self-Rated Disability Scale (LSDSR)
|
7.58 LSDSR Score
STANDARD_DEVIATION 6.43 • n=5 Participants
|
10.0 LSDSR Score
STANDARD_DEVIATION 5.41 • n=7 Participants
|
8.79 LSDSR Score
STANDARD_DEVIATION 5.83 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe Liebowitz Social Anxiety Scale (LSAS; Liebowitz, 1987) is a 24-item scale that provides separate scores for fear and avoidance in social and performance situations with higher scores representing increased social anxiety. The LSAS contains three total scores: 1) total fear score (0-72), 2) total avoidance score(0-72), 3) and total overall score (0-144). Suggested interpretations: 55-65 Moderate social phobia, 65-80 Marked social phobia, 80-95 Severe social phobia, Greater than 95 - Very severe social phobia.
Outcome measures
| Measure |
Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2)
n=13 Participants
Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 13 received 60mg duloxetine plus placebo for 18 additional weeks.
|
Duloxetine 120mg/Day for 18 Weeks (Phase 2)
n=15 Participants
Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 15 received 120mg duloxetine for 18 additional weeks.
|
|---|---|---|
|
Anxiety Symptoms as Assessed by Liebowitz Social Anxiety Scale
|
67.9 Scores on a scale
Standard Error 7.60
|
53.7 Scores on a scale
Standard Error 7.90
|
SECONDARY outcome
Timeframe: 6 monthsThe Clinician Global Impression-Severity Scale (CGI-S) is a clinician-rated instrument used to assess global severity of symptoms (Guy, 1976). The CGI ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Baseline collected for Phase 1 at week 0 and for Phase 2 at week 6.
Outcome measures
| Measure |
Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2)
n=13 Participants
Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 13 received 60mg duloxetine plus placebo for 18 additional weeks.
|
Duloxetine 120mg/Day for 18 Weeks (Phase 2)
n=15 Participants
Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 15 received 120mg duloxetine for 18 additional weeks.
|
|---|---|---|
|
CGI-S
|
4.42 Scores on a scale
Standard Error 0.48
|
3.60 Scores on a scale
Standard Error 0.57
|
Adverse Events
Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Duloxetine 120mg/Day for 18 Weeks (Phase 2)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2)
n=13 participants at risk
Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 13 received 60mg duloxetine plus placebo for 18 additional weeks.
|
Duloxetine 120mg/Day for 18 Weeks (Phase 2)
n=15 participants at risk
Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 15 received 120mg duloxetine for 18 additional weeks.
|
|---|---|---|
|
General disorders
Elevated Liver Function Tests
|
7.7%
1/13 • Number of events 1
|
0.00%
0/15
|
|
General disorders
Study medication overdose
|
7.7%
1/13 • Number of events 1
|
0.00%
0/15
|
Other adverse events
| Measure |
Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2)
n=13 participants at risk
Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 13 received 60mg duloxetine plus placebo for 18 additional weeks.
|
Duloxetine 120mg/Day for 18 Weeks (Phase 2)
n=15 participants at risk
Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 15 received 120mg duloxetine for 18 additional weeks.
|
|---|---|---|
|
General disorders
Sedation and other side effects
|
0.00%
0/13
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Increased drinking
|
0.00%
0/13
|
6.7%
1/15 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place