Paroxetine in the treatment of Chinese patients with depressive episode: a double-blind randomized comparison with imipramine.

BACKGROUND: Paroxetine is a potent inhibitor of serotonin re-uptake. Although it has been widely used as an antidepressant in western countries, its efficacy and side effects in the Chinese are unknown. METHODS: Patients with major depressive episode were recruited from the outpatient clinic and the acute wards of the Department of Psychiatry, Veterans General Hospital-Taipei in 1994. Severity of depression was evaluated with Hamilton Rating Scale for Depression (HAM-D), Clinical Global Impression (CGI) and the adverse effects were evaluated with Treatment Emergent Symptom Scale (TESS). Forty Chinese patients with HAM-D scores > or = 18 at the beginning of the first dose were randomized to receive paroxetine (20 to 30 mg/day) or imipramine (100 to 125 mg/day). The dosage was designed as a fixed-adjustable regimen for an active treatment period of six weeks. The patients and the clinical investigators were both blind to the medication until the end of the trial. RESULTS: Five patients violating the trial protocol were excluded from this study, leaving 35 patients for efficacy and adverse effect analyses. Sixty-seven percent (12/18) of paroxetine-treated patients and 65% (11/17) of imipramine-treated patients showed a 50% or more reduction in HAM-D scores. The rate of patients whose mood recovered to normal or near-normal (borderline) was higher in the paroxetine group (66.7%) than in the imipramine group (35.3%), but the difference was not statistically significant (p = 0.13). At the end of this trial, the mean reduction of HAM-D scores was similar between groups (20.2 +/- 9.1 vs 15.3 +/- 8.4, p > 0.1). Three patients in the paroxetine group and two patients in the imipramine group withdrew prematurely due to adverse effects of impatience. Adverse effects of anticholinergic effects were reported more frequently in the imipramine group than in the paroxetine group (p = 0.01). CONCLUSIONS: In comparison with imipramine, paroxetine affords fewer anticholinergic adverse effects without the sacrifice of efficacy in the treatment of depressed Chinese patients.