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(3), Pp. 201-203 CLERICAL TRIAL of SINTAMIL and DOXEPIN HCL IN

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(3), Pp. 201-203 CLERICAL TRIAL of SINTAMIL and DOXEPIN HCL IN Indian journal of Pryihiatrj. July 19*6, 2»(3), pp. 201-203 CLERICAL TRIAL OF SINTAMIL AND DOXEPIN HCL IN DEPRESSED PATIENTS • "RK MAHENDRU •" S MAHENDRU Sintamil (2330 GO) a new dibenzoxa- the depth of depression was evaluated on zepin (Nitroxazepine hydrochloride) has Hamilton depressive rating scale. The dura­ been extensively studied during the last tion of trial was 4 weeks. Each patient was decade in animals and human beings for its clinically examined to exclude the presence antidepressant action with fairly good re- of any organic disease. Pregnant women, Milts (Hagadia cf ill 19f>8 and Tcja and Na- patients with prostatic hypertrophy and rang 197D). Some investigators (Desou/a those with history ot epilepsy were not int­ and Chowdhary 1974 and Gupta ct.il 1976) ituled in the study. liave been demonstrated superiority ot sin­ These patients were not given any anti­ tamil over imiprainine and trimipramine in depressant therapy tor atleast one week be­ relciving depressive symptoms. fore the commencement of trial. The cap­ Dexepin being a tricyclic compound, sules containing Sintamil and Doxcpine has its basic action similar to other com­ were identical in size, shape and colour ami pounds ot the group (Groton 1967). It is it was not known to investigator whether a tertiary amine like Amtriptyline and Imi­ particular patient was on Sintamil or Do­ prainine which has mood elevating proper­ xcpine. Both the Sintamil as well as Doxc- ties (Arieti 1975). Some workers have rated pin were administered at bed time. The pa­ it as good or slightly superior to Iniipramine tients were examined every week and fresh and Amitriptylme whereas Swiss psychia­ drug samples issued. The detailed report on trists have not found it so (Frank 1968). symptoms scores, concomitant treatment The present report a single blind con­ and individual side effects were recorded trolled comparative between patient clini­ every week. Routine investigations like cal trial with Sintamil and Doxcpine hyd­ haemoglobin estimation, leukocyte count rochloride aims to evaluate their efficacy and urine analysis were done in every pat­ and tolerability in depressed patients. ient before and at the end of trial. Material and Methods Results The study consisted depressed patients There were 40 patients in the trial, 20 attending Mental Health Clinic at G. S. V. each on Sintamil and Doxepin. Males and M. Medical College and Associated Hospi­ females in the Doxepin as well as Sintamil tals, Kanpur. The diagnosis ot depression groups were more or less equally distribut­ was made according to 1. C. D. - 9 (1978). ed (12 males and 8 females in Sintamil The patients were randomly selected and group and 11 males and 9 females in Doxe- * Pi per presented at 38th Annual Conference of Indian Psychiatric Society, held at Jaipur. ** Reader in psvchiatrv. x " Ex - Demonstrator in pharmacology. G.S.V.M. Medical College. Kanpur - 208 002. 202 R K MAHENDRU & S MAHENDRU epin group). The average age was 46.16 80% patients on Sintamil as compared to years in the Sintainil group and 44.3 years in 35% patients with Doxepin. None of the Doxepine group. Twenty five patients patients on Sintainil complained ot un­ were having manic depressive psychosis wanted effects while one fourth patients on (Depressed phase), 14 had psychotic de­ Doxepon had undesirable effects like dryn­ pressive reaction and one patient was suf­ ess of mouth, drowsiness and giddiness. fering from neurotic depression. Discussion The table reveals a comparatively hig­ her reduction in most of the symptoms There was more than 75% improve­ score on Hamilton rating scale in patients ment in total symptom score in 80'"o pa­ with Sintamil as compared to Doxepin tients treated with Sintamil as compared to group both at the end of first week as well 35% patients receiving Doxepin. There are Table Percentage Reduction in Symptom Score SINTAMIL DOXEPIN Hcl (n - 20) (n - 20) Symptom* Day 0 Day 7 Day 28 Day 0 Day 77 Day 28 Av. score %% reduction Av. score %% reductioredi n Sandneu/DeprcMed mood 2.7 352 68.6 2.7 20.4 . 42.426i Self depreciation 2.1 35.7 72.5 2.1 122 48.X8 Self reproach St guilt feelings 2.2 34.1" 81.0* 2.0 7.7' 48.48.77 * Anxiety 22 36.4 80.5 22 22.7 59.1 Agitation 2.2 372 87.5' 22 20.5 59.59.11 " Katardatioii 1.8 25.0 71.4 22 17.1 41.41.55 * Social withdrawal 1.9 29.7 80.6' 2.2 14.0 515122 ' Simidal idra> 1.8 50.0 85.7 1.8 27.8 66.7 1 cm of intight 1.4 52.2 86.4 1.4 26.1 652 Somatic preoccupation 2.8 37.5 69.8 29 22.8 42.1 Inuininia 2.8 44.6 86.8 2.9 27.6 63.8 Lost of appetite 2.4 38.3 71.1 2.6 15.7 43.1 Sexual weaknesi 2.0 50.0 KX1.1(X).0 _- _- _- Total 24.9 372 77.6 25.7 19 J 51.3 • (p < 0.05) fourth week. However, some of the symp­ other reports in the literature which have toms such as self reproach and guilt fee­ not found Doxepine to be an effective anti­ lings, agitation and social withdrawl have depressant (Frank 1969). However Shanr.J shown significant reduction in patients on and Hegde (1980) have reported good re­ Sintamil as compared to Doxepin. At the sults with Doxepin in patients with mode­ last available follow up, more than 75% re­ rately severe depression. duction in total global score was seen in CLINICAL TRIAL OF SINTAMIL AND DOXEHN HCL IN DEPRESSED I'ATIENTS 2<>\ Though most of the depressive symp­ BAGADIA, V. N„ SI IAH, L. P., SH ARAF. V. R„ toms responded favourably to sintamil the­ DOSHI, S. V., SETH, V. K. (1968), Phase I rapy hut it was found more effective in con­ Clinical study of (Jo 2.130 in Depression, Indian Journal oj Psyihiatry 10, 64-72. trolling self reproach and guilt feelings, agi­ tation and social withdraw). Desuza and DE SOU/A. A. & CHOUDIIARY, P. C. (1974), Double blind lri.il of Siiilarml in Chowdlury (1974) have also found similar Depression, Indian Journal of Psyihiatry, 16, results with Sintamil in controlling most of 159-164. the depressive symptoms than imipraminc FRANK, J. Jr. (1969), A clinical evaluation of while Varma (1972) reported superiority of Doxepine, Journal oj Nervous Diseases 30, Sintamil in treating sadness, anxiety retar­ 396-397. dation, insomnia and loss or appetite than (JROTON, A. CONN (1967), Clinical research tnmipr.imine. Sintamil also appears to offer department Chas, Pfi/.cr Company Inc. mo­ an additional advantage of early onset of ac­ nograph on 3693. tion as even at the end of first week there was GUPTA, A. K. & MANKODI, N. A. (1976), A significant reduction in the scores of some of review of double blind trials with Sintamil and Imipraminc in depression, Antiseptic, the complaints in patients treated with Sinta­ 4:193-200. mil than those receiving Doxepine. International Classification of Diseases, ninth revi­ sion 1978. The drug seems to be completely free SHARMA, S. D. & HEGDE R. (1980), Thera­ from side effects as none of the patient on peutic efficacy of Doxepine in divided and Sintamil reported any unwanted or undesir­ single dose regime, Indian Journal of Psychia­ able effects, while one fourth patients treated try, 28. 283 287. with Doxepine had side effects like dryness TEJA, J. S. & NARANG, R. L. (1970), A double of mouth, giddiness and drowsiness. blind trial of three antidepressant ((Jo 2998, Go 2330 ami Imipraniiiic hydroi liloride), In­ dian Journal of Psyihiatry, 12:253-259. References VARMA, H. (1972), A double blind (rial with AR1ETI S1LVANO (1975). American hand Sintamil and Trumpraminc in depression. book <.•>( INyi hiatty. Now York. Basic book Proceedings ol the CI HA Symposium held in Inc. Publishers. Vol. 5, 482. Bombay page 109. .
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