A randomized, double-blind controlled comparison of nefazodone and paroxetine in the treatment of depression: safety, tolerability and efficacy in continuation phase treatment.

Author(s): Baldwin DS, Hawley CJ, Mellors K, CN104-070 Study Group

Affiliation(s): Community Clinical Sciences Research Division, Faculty of Medicine, Health and Biological Sciences, University of Southampton, UK. dsb1@soton.ac.uk

Publication date & source: 2001-09, J Psychopharmacol., 15(3):161-5.

Publication type: Clinical Trial; Randomized Controlled Trial

We investigated the safety, tolerability and efficacy of nefazodone and paroxetine in the continuation phase of treatment of depression. The study comprised a double-blind, parallel-group comparison over 4 months, of patients who had previously improved following random allocation to nefazodone or paroxetine during an 8-week acute treatment study. Assessments included Clinical Global Impression Scales, Hamilton Rating Scales for Depression and Anxiety, Montgomery-Asberg Depression Rating Scale and the Patient Global Assessment Scale, in addition to a review of reported adverse events, vital sign measurements, electrocardiograms and clinical laboratory tests. One hundred and eight patients participated in the continuation study (53 received paroxetine, 55 nefazodone) and 73 completed treatment. No clinically relevant differences in antidepressant efficacy were seen. Headache and somnolence were the most common reported adverse events in both treatment groups. Both nefazodone and paroxetine maintain their efficacy in continuation treatment, and both are generally well tolerated.