Double-blind, multicenter comparative study of sertraline versus amitriptyline in outpatients with major depression

被引:28
作者
Möller, HJ
Glaser, K
Leverkus, F
Göbel, C
机构
[1] Univ Munich, Dept Psychiat, D-80336 Munich, Germany
[2] Inst Psychodiagnost Psychosomat & Behav Med, Grevenbroich Gustorf, Germany
[3] Dept Clin Res, Pfizer Karlsruhe, Germany
关键词
D O I
10.1055/s-2000-8357
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Objective: To compare the efficacy and safety of sertraline and amitriptyline in a German outpatient population. Methods: Patients with Major Depression (DSM-III-R) and HAM-D (21 items) greater than or equal to 21 in 19 German centers received double-blind treatment with sertraline (initial dose 50 mg, titration up to 700 mg) or amitriptyline (75 mg, up to 150 mg) over 6 weeks. HAM-D (21 items), HAM-D Bech, CGI, DSI and SDS were evaluated for the efficacy analysis. FSUCL (Fischer Somatic and Undesired Effects Check List) and spontaneously reported adverse events were used for safety analysis. Results: Of the 240 patients enrolled in the study, 205 (100 sertraline; 105 amitriptyline) were evaluable for efficacy. No statistically significant differences were detected between the two groups in the ITT and ATP efficacy analyses. Response, defined as score 1 (very much improved) or 2 (much improved) of the CGI improvement score, was 76% in the sertraline and 81 % in the amitriptyline group (efficacy evaluable patients = ATP population). In the structured FSUCL, the side-effect burden (FSUCL score >2 for drug related symptoms) was significantly higher in the amitriptyline group at all follow up visits (p < 0.05). Conclusion: Both sertraline and amitriptyline are suitable for the treatment of Major Depression; sertraline is comparable to amitriptyline with regard to efficacy, and offers the additional benefit of a more favorable safety profile.
引用
收藏
页码:206 / 212
页数:7
相关论文
共 31 条
[1]   LIFE SATISFACTION AND PSYCHOSOCIAL FUNCTIONING IN CHRONIC DEPRESSION - EFFECT OF ACUTE TREATMENT WITH ANTIDEPRESSANTS [J].
AGOSTI, V ;
STEWART, JW ;
QUITKIN, FM .
JOURNAL OF AFFECTIVE DISORDERS, 1991, 23 (01) :35-41
[2]   DOUBLE-BLIND-STUDY OF THE EFFICACY AND SAFETY OF SERTRALINE VERSUS FLUOXETINE IN MAJOR DEPRESSION [J].
AGUGLIA, E ;
CASACCHIA, M ;
CASSANO, GB ;
FARAVELLI, C ;
FERRARI, G ;
GIORDANO, P ;
PANCHERI, P ;
RAVIZZA, L ;
TRABUCCHI, M ;
BOLINO, F ;
SCARPATO, A ;
BERARDI, D ;
PROVENZANO, G ;
BRUGNOLI, R ;
ROZZINI, R .
INTERNATIONAL CLINICAL PSYCHOPHARMACOLOGY, 1993, 8 (03) :197-202
[3]   THE EFFICACY OF SELECTIVE SEROTONIN REUPTAKE INHIBITORS IN DEPRESSION - A METAANALYSIS OF STUDIES AGAINST TRICYCLIC ANTIDEPRESSANTS [J].
ANDERSON, IM ;
TOMENSON, BM .
JOURNAL OF PSYCHOPHARMACOLOGY, 1994, 8 (04) :238-249
[4]   QUANTITATIVE RATING OF DEPRESSIVE STATES [J].
BECH, P ;
GRAM, LF ;
DEIN, E ;
JACOBSEN, O ;
VITGER, J ;
BOLWIG, TG .
ACTA PSYCHIATRICA SCANDINAVICA, 1975, 51 (03) :161-170
[5]  
BENNIE EH, 1995, J CLIN PSYCHIAT, V56, P229
[6]   BLOCKADE BY NEWLY-DEVELOPED ANTIDEPRESSANTS OF BIOGENIC-AMINE UPTAKE INTO RAT-BRAIN SYNAPTOSOMES [J].
BOLDENWATSON, C ;
RICHELSON, E .
LIFE SCIENCES, 1993, 52 (12) :1023-1029
[7]   THE APPLICATION OF REML IN CLINICAL-TRIALS [J].
BROWN, HK ;
KEMPTON, RA .
STATISTICS IN MEDICINE, 1994, 13 (16) :1601-1617
[8]  
COHN CK, 1990, J CLIN PSYCHIAT, V51, P28
[9]   A DOUBLE-BLIND, PLACEBO-CONTROLLED COMPARISON OF SERTRALINE AND DOTHIEPIN IN THE TREATMENT OF MAJOR DEPRESSION IN GENERAL-PRACTICE [J].
DOOGAN, DP ;
LANGDON, CJ .
INTERNATIONAL CLINICAL PSYCHOPHARMACOLOGY, 1994, 9 (02) :95-100
[10]   SERTRALINE SAFETY AND EFFICACY IN MAJOR DEPRESSION - A DOUBLE-BLIND FIXED-DOSE COMPARISON WITH PLACEBO [J].
FABRE, LF ;
ABUZZAHAB, FS ;
AMIN, M ;
CLAGHORN, JL ;
MENDELS, J ;
PETRIE, WM ;
DUBE, S ;
SMALL, JG .
BIOLOGICAL PSYCHIATRY, 1995, 38 (09) :592-602