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Antidepressant effects and unintended effects of paroxetine (30 mg/day) and clomipramine (150 mg/day) were compared in a double-blind, randomized, inpatient, fixed-dose, plasma-level-controlled study. Patients with a DSM-III diagnosis of major depressive disorder participated. After 1 week of single-blind placebo treatment 120 patients fulfilled the criterion of a Hamilton (17-item) score of ≥18 and were started on active treatment for 6 weeks. Drop-outs on paroxetine (n = 12) were largely due to lack of effect, and on clomipramine (n = 19) due to lack of effect (n = 7), adverse reactions or severe side effects (n = 10) and development of mania (n = 2). According to the protocol, non-responders (Hamilton total ≥ 16) after 4 weeks active treatment were terminated, and this occurred to 23 patients on paroxetine and four patients on clomipramine. Categorical response measures and group averages of rating scores …