Post-Marketing Study for the Safety and Effectiveness of Moclobemide Among Patients with Depression in Family Practice Outpatient Clinic

가정의학과 외래 우울증환자에서 moclobemide의 안전성 및 유효성 평가를 위한 시판후조사

Background : Depression is quite a common disease in primary care however, studies for the safety and effectiveness of antidepressants in primary care setting are rare in Korea. Objectives : This multi-centered post-marketing study was performed to evaluate the safety and effectiveness of Moclobemide and to find out the factors related to the adherence among patients with depression in family practice. Methods : A total of 386 patients were enrolled from July 1999 to January 2000 by twenty family doctors from fifteen family practice centers. They were prescribed Moclobemide and were reevaluated at the 4th, 8th, and l2th week. Evaluation of compliance, safety and effectiveness were performed with pre-made, structured self-reported questionnaires. Evaluation of effectiveness was also performed utilizing self-rating depression scale (SDS). Results : Among 386 patients, safety was evaluated in 310 patients and effectiveness was evaluated in 239 patients. During the first 12 weeks, the number of subjects continuing with Mocclobemide was 136(37.1%). 141 subjects (38.4%) discontinued taking the drug and 90 subjects (24.5%) dropped out at the 12th week. Considering drop-out patients as ineffective cases, overall effectiveness was estimated to be 84.5%. Symptoms improved with time in patients whose follow-up were completed (P<0.01). The SDS score decreased by an average of ${6.8{\pm}9.1(12.2{\pm}19.1%)}$ after 12 weeks(p<0.01). During the study, 33(10.6%) subjects reported adverse events. The most commonly reported adverse events, in descending order, were dizziness(2.3%), headache(1.6%), insomnia(1.3%), facial edema(1.3%), constipation(1.0%), nausea(1.0%) and tremor(1.0%). The main reasons for discontinuing antidepressants were attributed to improvement of symptoms and manifestation of adverse events. Conclusion : The percentage of adherence at 12th week of Moclobemire among patients suffering from depression in the family practice outpatient clinic was shown to be 49%. The antidepressant effect and safety of Moclobemide was relatively superior.