Abstract

Tatjana Tianmei and Grace Liang

Results of randomized, placebo- controlled trials with the selective serotonin reuptake inhibitor citalopram suggest that this agent is safe and effective for the treatment of depressive disorders. We investigated the safety and efficacy of citalopram in the treatment of Chinese patients with depressive disorders. An 8-week, open-label, multicenter study evaluated the safety and efficacy of citalopram in the treatment of patients with an ICD-10 diagnosis of depressive disorder or depressive episode of bipolar disorder. Efficacy measures included the Hamilton Rating Scale for Depression (HAMD) and the Clinical Global Impression (CGI). A total of 6080 patients (2553 men, 3527 women) (mean age 40.9 ± 15.6 years, range 18 – 92) participated in the study. Mean HAMD scores decreased significantly (p<0.001) after 2 weeks of treatment and at all subsequent study visits. Endpoint analyses showed that 89.9% of the patients demonstrated a clinical response, defined as a 50% reduction in HAMD scores. The mean daily dose of citalopram at endpoint was 23.65 mg. Nausea (7.6%), headache (3.7%) and dry mouth (2.9%) were the most frequently reported adverse events. Patients with bipolar depression and comorbid obsessive compulsive disorder (OCD) received a higher mean daily dose (26.4 and 27.7 mg, respectively), while patients with comorbid physical disorders received a lower dose (21.9 mg) than patients with simple depressive disorder. The results of this 8-week open-label study suggest that citalopram is safe and effective in the treatment of depression in Chinese patients. Limitations is an open-label and uncontrolled.