Treatment of bipolar depression with topiramate

Abstract

A 10-week study is reported on the safety and efficacy of fluoxetine (32 patients, 20 mg/day) and amitriptyline (33 patients, 50–100 mg/day). The subjects were aged ≧ 60 years, meeting the criteria of the American Psychiatric Association (DSM-III-R) for major depressive disorders and scoring ≧ 16 on the 17-item Hamilton rating scale for depression. After the administration of single-blind placebo for 1 week, eligible patients were randomized to a 10-week double-blind fluoxetine or amitriptyline treatment. Efficacy and adverse reactions were assessed at weeks 1, 2, 4, 7 and 10. The scores of Hamilton depression rating scale, Montgomery-Asberg depression rating scale, the Covi anxiety scale, the clinical global impressions scales, the patient global impression, the Nottingham health profile and the Leeds sleep evaluation questionnaire significantly (p < 0.001) improved in both treatment groups by the end of treatment compared to the starting values. Significant differences (p < 0.0001) were found between the two groups in the central nervous system adverse effects profile. Amitriptyline was associated more frequently to dizziness, reduced attention and confusion, and fluoxetine to headache, somnolence and asthenia. A significant increase in body weight (p = 0.002) was also observed in the amitriptyline group. A similar linear decreasing trend of adverse reactions was found int the two groups, but patients treated with amitriptyline displayed a higher persistency of the adverse reactions.