A multicenter (phase IV) trial conducted in psychiatry departments of
nine Portuguese hospitals evaluated the efficacy, safety, and tolerabi
lity of mexazolam. Four hundred nine patients diagnosed with anxiety d
isorder according to DSM-III-R classification were enrolled. The study
lasted 28 days, with clinical observations on days 0, 7, and 28. Acco
rding to baseline score on the Hamilton Anxiety Rating Scale, patients
received 2 or 3 mg/d of mexazolam. At each observation, a list of 27
symptoms was used to assess the evolution (frequency and severity) of
somatic anxiety components. The Hamilton Anxiety scale and the Negativ
e Symptom Rating Scale: B-Cognition III (x-Memory) were used as object
ive tests. A 57% reduction in the Hamilton Anxiety Rating Scale score
was observed between days 0 and 28. The incidence and severity of psyc
hological and somatic anxiety symptoms were also reduced. Side effects
were reported by 17.7% of patients and interfered with normal daily a
ctivity in only 4%. Mexazolam proved to be a potent anxiolytic devoid
of major sedative side effects.