A RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY OF TROPISETRON IN THE TREATMENT OF OUTPATIENTS WITH GENERALIZED ANXIETY DISORDER

The selective 5HT3 antagonist tropisetron was studied in 91 outpatient s meeting DSM-III criteria for Generalized Anxiety Disorder. Following a placebo wash-out period of up to 1 week, one of three active treatm ents (tropisetron 0.5 mg, 5 mg, or 25 mg daily) or placebo was given f or a further 3 weeks. After 7 days treatment termination rates due to inefficacy showed a statistically significant dose-related therapeutic effect of tropisetron. Similar effects were seen on the Hopkins Sympt om Check List total score and the Global Impression Scale. The Hamilto n Anxiety Scale showed a similar trend which, however, failed to reach statistical significance. At day 21 tropisetron showed significant do se-dependent effects on all anxiety-related outcome measures. The inci dence of adverse events was low and the severity generally mild. Most frequent complaints were headache, nausea, constipation and nervousnes s. Laboratory tests and physical examination performed at baseline and study end showed no significant treatment effects.