title: Efficacy and safety of two dosing regimens of buspirone in the treatment of outpatients with persistent anxiety.
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 > or = 18 on the Hamilton Rating Scale for Anxiety (HAM-A). After a 7-day placebo lead-in phase, patients who continued to qualify 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 mean HAM-A total scores and improvement on Clinical Global Impression measures, with no significant differences detected between the two treatment 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.
authors.affiliation: California Clinical Trials, Beverly Hills, USA.
authors.forename: J J
authors.initials: JJ
authors.lastname: Sramek
authors.forename: E J
authors.initials: EJ
authors.lastname: Frackiewicz
authors.forename: N R
authors.initials: NR
authors.lastname: Cutler
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D014151:Anti-Anxiety Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D001007:Anxiety / Q000188:drug therapy* / Q000523:psychology; D002065:Buspirone / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D002908:Chronic Disease; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales
chemical_list: D014151:Anti-Anxiety Agents; D002065:Buspirone