The purpose of this study is to examine the effectiveness and tolerability of augmentation treatment of ziprasidone to achieve remission among patients with social anxiety disorder (SAD) who did not remit on sertraline treatment alone
This is a two-phase study consisting of 8 weeks of open label treatment with sertraline (50-200 mg/day) in patients with SAD and in those who fail to demonstrate symptom remission on sertraline alone, 8 weeks of randomized, double-blind, placebo-controlled augmentation with ziprasidone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
51
Sertraline augmentation with ziprasidone
Treatment by sertraline in open label phase, followed by ziprasidone/placebo randomized augmentation in the randomized phase
Duke University Medical Center
Durham, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Brief Social Phobia Scale(BSPS)
An observer measure of social phobic symptoms, referred to as the Brief Social Phobia Scale, consists of 11 items, 7 evaluating commonly feared or avoided situations and 4 additional items measuring autonomic distress. A total numerical range of 0-88 is scored on this measure, with higher scores representing greater severity of social anxiety disorder symptoms.The total score is computed as a simple sum of the 11 items.
Time frame: Baseline, 8 and 16 weeks
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