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Summary
A double-blind controlled trial was carried out in 80 depressed out-patients to compare the efficacy and tolerance of mianserin with that of a fixed combination preparation of amitriptyline and chlordiazepoxide. After a wash-out period of at least 1 week, the patients were allocated at random to treatment with one or other of the trial drugs for 4 weeks. During the first week, patients received 30 mg mianserin per day or 37.5 mg amitriptyline plus 15 mg chlordiazepoxide per day. Thereafter, they received 50 mg mianserin per day or 62.5 mg amitriptyline plus 25 mg chlordiazepoxide per day. Assessments, using the Hamilton Rating Scale for Depression, the Zung Self-Rating Depression Scale, the Clinical Global Impressions Scale and a questionnaire for somatic findings and side-effects, were carried out before treatment and at the end of Weeks 1, 2 and 4. Psychometric tests, including the Taylor Manifest Anxiety Rating Scale, the von Zerssen Mood Self-Rating Scale, and the 11-item Freiburger Personality Inventory (FPI) were carried out before treatment and at the end of Weeks I and 4. Both treatment groups showed a moderate and statistically significant improvement in their depressive symptomatology by the end of the first week and a marked and highly significant improvement thereafter. While the gross psychopathological evaluations did not yield any significant inter-drug differences, analyses of the FPI showed a significant superiority of mianserin over the amitriptyline preparation in the item ‘agitation’. As the items ‘nervousness’ and ‘emotional lability’ also showed a fast and significant improvement mianserin appears to be a drug of choice for agitated depression. Evaluation of somatic symptoms and side-effects demonstrated that mianserin produced initially more diurnal drowsiness, but generally less dryness of mouth, constipation and weight gain, and alleviated headache to a greater extent than did the amitriptyline I chlordiazepoxide combination.