FLUVOXAMINE VERSUS IMIPRAMINE AND PLACEBO - A DOUBLE-BLIND COMPARISONIN DEPRESSED-PATIENTS

Approximately 20 million patients suffer from major depressive disorde r each pear, indicating a need for antidepressant agents that are syno nymous with effectiveness, tolerability and patient compliance. The au thors examined the effects of fluvoxamine, a selective serotonin reupt ake inhibitor, in the treatment of out-patients meeting DSM-III-R crit eria for major depressive disorder. A randomized, double-blind, parall el group, placebo- and imipramine-controlled single center study was c onducted in 150 outpatients. Patients were randomized to receive up to 150 mg/day of fluvoxamine as a single bedtime dose, 240 mg/day of imi pramine on a twice-daily (BID) schedule, or placebo for six weeks. Eff icacy measurements included HAM-D, MADRS, CGI, Raskin-Covi and SCL-56 scales. The HAM-D total score indicated that both active treatment gro ups showed significantly (p less than or equal to 0.05) greater therap eutic benefit than did placebo. Severely depressed patients(HAM-D grea ter than or equal to 30) responded better to fluvoxamine in five of si x measures. Side-effects from fluvoxamine were similar to those report ed for other selective serotonin reuptake inhibitors (nausea, somnolen ce) and were well tolerated. Imipramine was associated with anticholin ergic effects such as dry mouth and dizziness. The pharmacokinetic pro perties of fluvoxamine which allow the drug to be administered as a si ngle daily dose should aid in the maintenance of patient compliance, w hile offering significant clinical benefit in the improvement of depre ssive symptoms.