zimeldine and Sleep-Wake-Disorders

The similarities and differences in the clinical response and incidence of adverse symptoms between zimeldine and amitriptyline have been evaluated by use of a combined analysis of four double-blind clinical trials in depression. In total, 197 patients were included in this series of studies. The efficacy of the drugs was assessed using the Hamilton Rating Scale for Depression (HAM-D). Reports of adverse symptoms were actively elicited by use of a check-list of symptoms and rated for severity. The overall clinical efficacy of the two drugs was shown to be equivalent with a high degree of statistical confidence. However, there exist differences in the profile of action. Amitriptyline has a significant advantage in insomnia problems. In spite of this zimeldine was shown to be at least as effective as amitriptyline in reducing anxiety. Amitriptyline is associated with significantly more anticholinergic side-effects, whereas headache is more disturbing during zimeldine treatment. The combination of several independent trials based on similar protocols can be a useful tool to increase the statistical reliability of conclusions relative to that which can be achieved in standard sized, individual studies in depression.

Topics: Adult; Amitriptyline; Anxiety; Clinical Trials as Topic; Depressive Disorder; Double-Blind Method; Female; Headache; Humans; Male; Middle Aged; Psychiatric Status Rating Scales; Sleep Wake Disorders; Zimeldine

Topics: Antidepressive Agents; Brompheniramine; Clinical Trials as Topic; Depression; Double-Blind Method; Drug Synergism; Humans; Pyridines; Sleep Wake Disorders; Tryptophan; Zimeldine

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.

Topics: Adolescent; Adult; Aged; Alanine Transaminase; Alkaline Phosphatase; Aspartate Aminotransferases; Body Weight; Child; Creatinine; Depressive Disorder; Electrocardiography; Female; Humans; Male; Middle Aged; Nausea; Sleep Wake Disorders; Time Factors; Zimeldine