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Abstract
This randomized, double-masked, comparative study evaluated the efficacy and safety
of buspirone 30 mg/d, administered twice a day (BID) or three times a day (TID), in
patients with generalized anxiety disorder (GAD), commonly called persistent anxiety.
Patients who participated had GAD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Third Edition, Revised, modified to include patients for whom the symptom duration was at least 4 weeks
and scored ≥ 18 on the Hamilton Rating Scale for Anxiety (HAM-A). After a 7-day placebo
lead-in phase, patients who continued to quality were randomized to receive buspirone,
titrated from 15 mg/d (5 mg TID) to 30 mg/d, as either a BID or TID regimen, for 8
weeks. Of the 137 patients who began the study, 120 patients were included in the
data evaluation. Both buspirone BID and TID treatment groups demonstrated significant
reductions in men HAM-A total scores and improvement on Clinical Global Impression
measures, with no significant differences detected between the two tretment groups
for either measure at any time point. The overall incidence of adverse events was
similar for both treatment groups, except for a significantly greater incidence of
amblyopia in patients receiving buspirone 15 mg BID. In summary, there was no appreciable
difference in efficacy or safety between buspirone 15 mg BID or 10 mg TID in patients
with persistent anxiety.
Keywords
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© 1997 Published by Elsevier Inc.
