Duloxetine For The Treatment Of Generalized Social Anxiety - MBL ...

over time in GSAD. Secondary efficacy measures
included the MADRS as a measure of depressive
symptoms, and three patient rated measures
of quality of life and disability: the three-item
Sheehan Disability Scale, 16 the 16-item Quality of
Life Enjoyment and Satisfaction Questionnaire
(Q-LES-Q), 17,18 and the GSAD specific 11-item
Liebowitz Self-Rated Disability Scale. 19
Safety monitoring included psychiatric
assessments, side-effect query, and vital signs at
each visit, as well as liver function tests at weeks
0, 6, 12, and 24. Study drop points for safety
were clinical worsening defined as an increase
in Clinical Global Impression of Severity ratings
(CGI-S) over baseline of >2 points, any liver function
test >3 times the upper limit of normal at
any assessment, or lack of compliance defined
as missing >4 consecutive days of study drug.
At the end of their study participation, subjects
received $30/visit for completing the assessments,
and were offered 3 months of follow up
clinical visits with a psychopharmacologist at
the end of the trial at no charge.
Data Analyses
All analyses were performed for a modified
ITT sample, as defined a priori, consisting of
subjects who had at least one assessment on
medication in Phase 1 or 2, respectively. After
confirmation that the primary outcome measure
was normally distributed, analyses examining
overall treatment effect consisted of paired ttests
for within subject change in Phase 1, Phase
2, and overall for the full 24 weeks. Primary analyses
comparing randomized dosing in Phase 2
consisted of between-subjects two-sided t-tests.
Binary indicators of clinical response (CGI-I=1
or 2) and remission (LSAS