The safety of zimeldine in long-term use in depressive illness.
The aim of this study was to evaluate the safety of zimeldine, a 5-HT reuptake inhibitor, in the long-term treatment of depressive disorders. The study was an open label, multicentre investigation involving 147 patients who were suffering from depressive illness and who needed long-term anti-depressant treatment. Sixty-five patients completed the intended treatment period of 1 year, 75 terminated prematurely, and 7 are still in the programme. The reasons for termination were mainly ineffectiveness of the drug and adverse reactions. During the long-term treatment the most common emergent symptoms were, in order of decreasing frequency, dizziness, dry mouth, sleep disorders, sweating, tremor, nausea and headache. The side-effects were, however, mild and they generally decreased during the treatment period. No new adverse symptoms were reported. In the long-term treatment group, body weight showed a slight mean decrease. Clinical chemistry and cardiovascular investigations were judged to show no changes of clinical importance. It is concluded that zimeldine was shown to be a safe drug in this 1-year treatment programme of depression.
D000293:Adolescent; D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D000469:Alkaline Phosphatase / Q000097:blood; D001219:Aspartate Aminotransferases / Q000097:blood; D001835:Body Weight / Q000187:drug effects; D002648:Child; D003404:Creatinine / Q000097:blood; D003866:Depressive Disorder / Q000188:drug therapy*; D004562:Electrocardiography; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D012893:Sleep Wake Disorders / Q000139:chemically induced; D013997:Time Factors; D015031:Zimeldine / Q000009:adverse effects*
D015031:Zimeldine; D003404:Creatinine; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; D000469:Alkaline Phosphatase