[Double-blind study of mianserin and fluoxetine in ambulatory therapy of depressed patients]

Abstract

A double blind controlled trial was carried out in 65 depressed out-patients to compare the efficacy and tolerance of mianserin with fluoxetine. The two compounds present very different pharmacological activities. Mianserin is an antagonist of the alpha 2-adrenergic receptors, while fluoxetine is an inhibitor of recapture specific to serotonin. Requirements for inclusion were: depressive episode of less than 2 months duration, meeting the criteria for one of the sub-types of depression described in DSM III, with a minimum score of 25 on the Montgomery Asberg Depressive Rating Scale (MADRS). The patient's ages ranged from 18 to 65. The only psychotropic medication allowed in association to the treatment was prazepam (up to 40 mg/day). Patients gave their written consent to the study. Assessment, using the Montgomery Asberg Depression Rating Scale (MADRS), the HARD diagram, the check list for somatic symptoms and side-effects was carried out before treatment and at the end of weeks 2, 4, 8. Assessment of anxiety using the Hamilton Anxiety Rating Scale (HARS) and of sleep disturbances using a sleep questionnaire was carried out before treatment and at week 4. The 8 items of the sleep questionnaire covers the complaints listed in criteria for insomnia disorders (307.42 DSM III-R). Clinical Global Impression (CGI), Therapeutic Index (TI), Tolerance Global Impression were assessed at end-point. The 2 groups were strictly comparable in respect to the clinical status at base line (diagnosis, history and duration of the depressive illness, MADRS and HARD diagram scores).(ABSTRACT TRUNCATED AT 250 WORDS)