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Duloxetine for Social Anxiety Disorder: Prediction of Long Term Outcome

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ClinicalTrials.gov Identifier: NCT00114127
Recruitment Status : Completed
First Posted : June 14, 2005
Results First Posted : June 7, 2012
Last Update Posted : June 10, 2014
Sponsor:
Information provided by (Responsible Party):
Naomi M. Simon, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition Anxiety Disorder
Interventions Drug: Duloxetine
Drug: Placebo
Enrollment 28
Recruitment Details Treatment seeking outpatients aged 18 years and older with a primary diagnosis of Generalized Social Anxiety Disorder (GSAD) were recruited by media advertisement.
Pre-assignment Details

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.

Arm/Group Title Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2) Duloxetine 120mg/Day for 18 Weeks (Phase 2)
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 13 15
Completed 9 11
Not Completed 4 4
Reason Not Completed
Adverse Event             2             1
Lost to Follow-up             1             0
Withdrawal by Subject             1             3
Arm/Group Title Duloxetine 60mg/Day + Placebo for 18 Weeks(Phase 2) Duloxetine 120mg/Day for 18 Weeks (Phase 2) Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 13 15 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Age Baseline Number Analyzed 13 participants 15 participants 28 participants
36.6  (14.2) 35.5  (11.6) 36  (12.6)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants 15 participants 28 participants
Female 7 4 11
Male 6 11 17
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants 15 participants 28 participants
Caucasian 9 13 22
Asian 1 1 2
Black 1 1 2
Alaskan Native 1 0 1
Native Hawaiian or Pacific Islander 1 0 1
Educational status, college graduate  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants 15 participants 28 participants
College Graduate 10 7 17
Not College Graduate 3 8 11
Duration of illness, mean years (SD)  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 15 participants 28 participants
27.6  (17.0) 20.1  (12.3) 23.7  (14.9)
Age of onset, mean age  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 15 participants 28 participants
9.9  (3.3) 13.9  (8.1) 12.0  (6.46)
Current comorbidity, Major depressive disorder (MDD)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants 15 participants 28 participants
Comorbid MDD 5 0 5
No Comorbid MDD 8 15 23
Current comorbidity, Dysthymia  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants 15 participants 28 participants
Comorbid Dysthymia 2 0 2
No Comorbid Dysthymia 11 15 26
Current comorbidity, Panic Disorder (PD)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants 15 participants 28 participants
Comorbid PD 1 0 1
No Comorbid PD 12 15 27
Current comorbidity, Generalized anxiety disorder (GAD)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants 15 participants 28 participants
Comorbid GAD 2 0 2
No Comorbid GAD 11 15 26
At least one concurrent mood or anxiety disorder  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants 15 participants 28 participants
Concurrent mood or anxiety disorder 7 1 8
No concurrent mood or anxiety disorders 6 14 20
Lifetime depression  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants 15 participants 28 participants
Lifetime depression 6 4 10
No Lifetime depression 7 11 18
Lifetime alcohol or substance abuse or dependence  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants 15 participants 28 participants
Lifetime Alcohol/substance abuse/dependence 3 3 6
No Lifetime Alcohol/substance abuse/dependence 10 12 22
Liebowitz Social Anxiety Scale (LSAS)   [1] 
Mean (Standard Deviation)
Unit of measure:  LSAS Score
Number Analyzed 13 participants 15 participants 28 participants
75.2  (6.90) 74.1  (6.20) 74.6  (4.52)
[1]
Measure Description:

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 (55-65 Moderate social phobia, 65-80 Marked social phobia, 80-95 Severe social phobia, Greater than 95 - Very severe social phobia). It is widely used in treatment studies of SAD. The instrument shows very good psychometric properties (Heimberg et al., 1999; Safren et al., 1999).

Baseline collected for Phase 1 at week 0 and for Phase 2 at week 6.

Clinical Global Impression-Severity (CGI-S)   [1] 
Mean (Standard Deviation)
Unit of measure:  CGI-S Score
Number Analyzed 13 participants 15 participants 28 participants
5.10  (0.43) 4.93  (0.36) 5.00  (0.27)
[1]
Measure Description:

The 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.

Clinical Global Impression-Improvement (CGI-I)   [1] 
Mean (Standard Deviation)
Unit of measure:  CGI-I Score
Number Analyzed 13 participants 15 participants 28 participants
3.25  (0.97) 3.36  (1.22) 3.31  (1.09)
[1]
Measure Description:

The Clinician Global Impression-Improvement Scale (CGI-I) is a clinician-rated instrument used to assess global improvement of symptoms (Guy, 1976). The CGI ranges from 1 (very much improved) to 7 (very much worse).

Baseline CGI-I was not collected in Phase 1 as it is a measure of improvement. Baseline CGI-I was collected in Phase 2 because patients were transitioning from week 6 to 7.

Montgomery Asberg Depression Rating Scale (MADRS)   [1] 
Mean (Standard Deviation)
Unit of measure:  MADRS Score
Number Analyzed 13 participants 15 participants 28 participants
8.08  (5.00) 10.3  (7.79) 9.17  (6.60)
[1]
Measure Description:

MADRS; Montgomery & Asberg, 1979. The MADRS is designed to measure the overall severity of depressive symptoms and has demonstrated good reliability and sensitivity to change with treatment. It includes 10 items and uses a 0-6 severity scale with higher scores indicating increasing depressive symptoms. Ratings can be added to form an overall score (range 0 to 60); no weights are used. Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression.

Baseline MADRS only collected in Phase 2 at week 6.

Sheehan Disability Scale (SDS)   [1] 
Mean (Standard Deviation)
Unit of measure:  SDS Score
Number Analyzed 13 participants 15 participants 28 participants
11.2  (6.06) 14.1  (5.52) 12.9  (5.71)
[1]
Measure Description:

The SDS is a brief self-report questionnaire that was developed to assess functional impairment in three inter-related domains; work/school, social and family life. The patient rates the extent to which work/school, social and family responsibilities are impaired by his/her symptoms on a 10 point visual analog scale. The three items are summed into a single dimension measure of global function impairment that ranges from 0 (unimpaired) to 30 (highly impaired).

Baseline SDS only collected in Phase 2 at week 6.

Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)   [1] 
Mean (Standard Deviation)
Unit of measure:  Q-LES-Q Score
Number Analyzed 13 participants 15 participants 28 participants
49.1  (8.83) 46.2  (9.47) 47.5  (9.12)
[1]
Measure Description:

Q-LES-Q; Endicott et al., 1993. This questionnaire rates 16 aspects of quality of life, including physical health, mood, activities of daily living, and overall life satisfaction. The scoring of the Q-LES-Q-SF involves summing only the first 14 items to yield a raw total score. The last two items are not included in the total score but are standalone items. The raw total score ranges from 14 to 70, with higher scores indicating higher satisfaction with quality of life.

Baseline QLESQ only collected in Phase 2 at week 6.

Liebowitz Self-Rated Disability Scale (LSDSR)   [1] 
Mean (Standard Deviation)
Unit of measure:  LSDSR Score
Number Analyzed 13 participants 15 participants 28 participants
7.58  (6.43) 10.0  (5.41) 8.79  (5.83)
[1]
Measure Description:

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.

Baseline was only collected for Phase 2 at week 6

1.Primary Outcome
Title Anxiety Symptoms as Assessed by Liebowitz Social Anxiety Scale
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2) Duloxetine 120mg/Day for 18 Weeks (Phase 2)
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 13 15
Mean (Standard Error)
Unit of Measure: Scores on a scale
67.9  (7.60) 53.7  (7.90)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2), Duloxetine 120mg/Day for 18 Weeks (Phase 2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.132
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title CGI-S
Hide Description

The 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.

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2) Duloxetine 120mg/Day for 18 Weeks (Phase 2)
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 13 15
Mean (Standard Error)
Unit of Measure: Scores on a scale
4.42  (0.48) 3.60  (0.57)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2), Duloxetine 120mg/Day for 18 Weeks (Phase 2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.292
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2) Duloxetine 120mg/Day for 18 Weeks (Phase 2)
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2) Duloxetine 120mg/Day for 18 Weeks (Phase 2)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2) Duloxetine 120mg/Day for 18 Weeks (Phase 2)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/13 (15.38%)      0/15 (0.00%)    
General disorders     
Elevated Liver Function Tests [1]  1/13 (7.69%)  1 0/15 (0.00%)  0
Study medication overdose [2]  1/13 (7.69%)  1 0/15 (0.00%)  0
[1]
The elevated LFTs were later diagnosed by primary care physician on evaluation as unrelated to study medication and a result of rhabdomyolysis from a week of intensive weight lifting and exercises.
[2]
The study medication overdose was in the context of alcohol use and suicidal ideation and had no medical consequences: this was deemed possibly related to duloxetine and the participant was transferred to clinical care.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2) Duloxetine 120mg/Day for 18 Weeks (Phase 2)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      2/15 (13.33%)    
General disorders     
Sedation and other side effects  0/13 (0.00%)  0 1/15 (6.67%)  1
Increased drinking  0/13 (0.00%)  0 1/15 (6.67%)  1
Open-label in phase Phase 1; Limited power due to small sample size.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Naomi Simon
Organization: Massachusetts General Hospital
Phone: 617-726-7913
EMail: nsimon@partners.org
Layout table for additonal information
Responsible Party: Naomi M. Simon, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00114127    
Other Study ID Numbers: 2004-P-001384
First Submitted: June 13, 2005
First Posted: June 14, 2005
Results First Submitted: January 27, 2012
Results First Posted: June 7, 2012
Last Update Posted: June 10, 2014