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
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Study Type | Interventional |
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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) |
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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 | |
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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 | |
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[Not Specified]
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Age, Customized
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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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 |
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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 |
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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. |
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Clinical Global Impression-Severity (CGI-S)
[1] Mean (Standard Deviation) Unit of measure: CGI-S Score |
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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. |
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Clinical Global Impression-Improvement (CGI-I)
[1] Mean (Standard Deviation) Unit of measure: CGI-I Score |
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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. |
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Montgomery Asberg Depression Rating Scale (MADRS)
[1] Mean (Standard Deviation) Unit of measure: MADRS Score |
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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. |
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Sheehan Disability Scale (SDS)
[1] Mean (Standard Deviation) Unit of measure: SDS Score |
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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. |
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Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
[1] Mean (Standard Deviation) Unit of measure: Q-LES-Q Score |
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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. |
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Liebowitz Self-Rated Disability Scale (LSDSR)
[1] Mean (Standard Deviation) Unit of measure: LSDSR Score |
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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 |
Name/Title: | Dr. Naomi Simon |
Organization: | Massachusetts General Hospital |
Phone: | 617-726-7913 |
EMail: | nsimon@partners.org |
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 |