Zimelidine vs. amitriptyline vs. placebo in a double‐blind study

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Abstract
Zimelidine, a new antidepressant compound structurally different from the tricyclics, is a potent and selective 5‐HT reuptake inhibitor which has been found an effective antidepressant in previous clinical trials. In this study, zimelidine was administered to one out of three subjects in a 60‐patient double‐blind controlled trial. This was part of a large multicenter study, performed in the United States of America. Patients were selected mainly from the Midtown Manhattan area in New York City. Following at least one week of placebo, patients were randomly assigned to zimelidine, amitriptyline or placebo for four weeks. Initial dosage of zimelidine was 25 mg t.i.d., later increased over the period of four weeks to 100 mg t.i.d.The rating instruments were the Hamilton Depression Scale (21 item version), the Beck Self‐Rating Scale and the Clinical Global Impression Scale. The side effects were recorded by active questionning according to a side effect inventory. Vital signs, laboratory work including ECG and plasma levels, were performed weekly.At the time of the report, two‐thirds of our study is completed and data regarding comparative efficacy of zimelidine vs. amitriptyline vs. placebo, as well as relative incidence of side effects is reported.*

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