Clinical Trial of Sintamil and Doxepin Hcl in Depressed Patients*

Sintamil (2330 GO) a new dibenzoxa-zepin (Nitroxazepine hydrochloride) has been extensively studied during the last decade in animals and human beings for its antidepressant action with fairly good re-Milts (Hagadia cf ill 19f>8 and Tcja and Na-rang 197D). Some investigators (Desou/a and Chowdhary 1974 and Gupta ct.il 1976) liave been demonstrated superiority ot sin-tamil over imiprainine and trimipramine in relciving depressive symptoms. Dexepin being a tricyclic compound, has its basic action similar to other compounds ot the group (Groton 1967). It is tertiary amine like Amtriptyline and Imi-prainine which has mood elevating properties (Arieti 1975). Some workers have rated it as good or slightly superior to Iniipramine and Amitriptylme whereas Swiss psychiatrists have not found it so (Frank 1968). The present report a single blind controlled comparative between patient clinical trial with Sintamil and Doxcpine hyd-rochloride aims to evaluate their efficacy and tolerability in depressed patients. The study consisted depressed patients attending Mental Health Clinic at G. S. V. M. Medical College and Associated Hospitals , Kanpur. The diagnosis ot depression was made according to 1. C. D.-9 (1978). The patients were randomly selected and the depth of depression was evaluated on Hamilton depressive rating scale. The duration of trial was 4 weeks. Each patient was clinically examined to exclude the presence of any organic disease. Pregnant women, patients with prostatic hypertrophy and those with history ot epilepsy were not int-ituled in the study. These patients were not given any anti-depressant therapy tor atleast one week before the commencement of trial. The capsules containing Sintamil and Doxcpine were identical in size, shape and colour ami it was not known to investigator whether a particular patient was on Sintamil or Do-xcpine. Both the Sintamil as well as Doxc-pin were administered at bed time. The patients were examined every week and fresh drug samples issued. The detailed report on symptoms scores, concomitant treatment and individual side effects were recorded every week. Routine investigations like haemoglobin estimation, leukocyte count and urine analysis were done in every patient before and at the end of trial. Results There were 40 patients in the trial, 20 each on Sintamil and Doxepin. Males and females in the Doxepin as well as Sintamil groups were more or less equally distributed (12 males and 8 females in Sintamil group and 11 males and 9 females in Doxe