Safety and efficacy of citalopram in the treatment of depressive disorders

Background: The objective of this post-marketing surveillance study was to document the efficacy and tolerability of the selective serotonin reuptake inhibitor citalopram in patients with depression under routine clinical conditions. Post-marketing surveillance studies permit to assess a substance in a much larger patient population and under real-life conditions than is possible in clinical trials and are therefore a useful tool to detect drug interactions and rare adverse drug reactions (ADRs). Patients and methods: 610 patients with an ICD-10 diagnosis of depression were treated with the generic citalopram for up to 12 weeks by 206 psychiatrists or neurologists. Outcome measures included the 17-item Hamilton Depression Scale (HAMD); the Clinical Global Impression Scale (CGI) and efficacy and safety/adverse drug reaction assessments. Results: Overall, HAMD and CGI severity score decreased significantly. About 75 % of the patients showed therapeutic response (HAMD reduction > 50 %) and 65 % showed remission (HAMD at end of study <= 7). 7.7 % of the patients had ADRs; only 0.5 % had serious ADRs. Gender did not influence the efficacy of the citalopram treatment, but younger persons, patients with a first episode of depression, patients without co-morbidities as well as patients with psychotropic co-medication had a significantly greater benefit of the citalopram treatment. The efficacy judgements of specialists and patients were highly correlated. Conclusion: Even under real-life conditions, the generic citalopram showed a comparable efficacy and a comparable safety as the original product citalopram investigated in previous clinical and placebo-controlled studies.