ELECTROCARDIOGRAPHIC FINDINGS DURING EXTENDED CLINICAL-TRIALS OF FLUVOXAMINE IN DEPRESSION - ONE YEARS EXPERIENCE

Introduction: Fluvoxamine, a selective serotonin reuptake inhibitor (S SRI), is used to treat depression, No significant effect on the electr ocardiogram (ECG) has been reported during short-term controlled studi es of SSRI's. We report a long-term (1 year) multi-center, double-blin d controlled study of the ECG during treatment of depression with fluv oxamine (FX), active control medication (TCA), and placebo(PLA), Metho d: Initially ECGs were obtained from 1840 physically healthy, depresse d outpatients who were treated with FX, TCA, or PLA for 6 weeks. A sub set of these patients continued treatment for up to one year, Complete sets of ECGs were obtained from 462 of these patients. Patients whose depression was substantially improved in the initial 6-week study ('' responder'') received the same medication. Non-responders received a b linded active medication. Pre-treatment, intra-study, and post-treatme nt ECGs were recorded according to protocol. One blinded electrocardio grapher measured and analyzed all ECG data. The effects of each medica tion upon the ECG were measured and compared. Results: Of the 462 pati ents, 311 used FX, 100 used TCA and 51 used PLA, Analyses of ECG data for each treatment focused on changes in ECG measurements; % of normal ECGs, and % of individual ECG findings. The ECG changes during FX tre atment were less than or not significantly different from the ECG chan ges with PLA treatment. The changes with TCA were as expected. Conclus ions: Fluvoxamine treatment of depression for one year was not associa ted with any significant effect on the ECG.