Duloxetine for Social Anxiety Disorder: Prediction of Long Term Outcome

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.

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.

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.

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.

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.

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.

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