A randomized, double-blind, placebo-controlled, parallel-group study was co
nducted to evaluate the efficacy and safety of gabapentin in relieving the
symptoms of social phobia. Sixty-nine patients were randomly assigned to re
ceive double-blind treatment with either gabapentin (dosed flexibly between
900 and 3,600 mg daily in three divided doses) or placebo for 14 weeks. A
significant reduction (p < 0.05) in the symptoms of social phobia was obser
ved among patients on gabapentin compared with those on placebo as evaluate
d by clinician- and patient-rated scales. Results were similar for the inte
nt-to-treat and week-a completer populations. Adverse events were consisten
t with the known side effect profile of gabapentin. Dizziness (p = 0.05), d
ry mouth (p = 0.05), somnolence, nausea, flatulence, and decreased libido o
ccurred at a higher frequency among patients receiving gabapentin than amon
g those receiving placebo. No serious adverse events or deaths were reporte
d. On the basis of these limited data, it seems that gabapentin offers a fa
vorable risk-benefit ratio for the treatment of patients with social phobia
. Further studies are required to confirm this effect and to determine whet
her a dose-response relationship exists.