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) ≥ 21 in 19 German centers received double-blind treatment with sertraline (initial dose 50 mg, titration up to 100 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.
References
-
1
Agosti V, Stewart J, Quitkin F.
Life satisfaction and psychosocial functioning in chronic depression: effect of acute treatment with antidepressant.
J. Affect. Disord..
1991;
23
35-41
-
2
Aguglia E, Casacchia M, Cassano G B, Faravelli C, Ferrari G, Giordano P, Pancheri P, Ravizza L, Trabucchi M, Bolino F, Scarpato A, Berardi D, Provenzano G, Brugnoli R, Rozzini R.
Double-blind study of the efficacy and safety of sertraline versus fluoxetine in major depression.
Int. Clin. Psychopharmacol..
1993;
8
197-202
-
3
Anderson I M, Tomenson B M.
The efficacy of selective serotonin re-uptake inhibitors in depression: a meta-analysis of studies against tricyclic anitdepressants.
J. Psychopharmacol..
1994;
8
238-249
-
4
Bech P, Gram L F, Dein E, Jacobsen O, Vitger J, Bolwig T G.
Quantitative rating of depressive states.
Acta psychiat. scand..
1975;
51
161-170
-
5
Bennie E, Mullin J M, Martindale J J.
A double-blind multicenter trial comparing sertraline and fluoxetine in outpatients with major depression.
J. Clin. Psychiatry.
1995;
56
229-237
-
6
Bolden-Watson C, Richelson E.
Blockade by newly-developed anti-depressants of biogenic amine uptake into rat brain synaptosomes.
Life Sciences.
1993;
52
1023-1029
-
7
Brown H K, Kempton R A.
The application of REML in clinical trials.
Statistics in Medicine.
1994;
13
1601-1617
-
8
Cohn C K, Shrivastava R, Mendels J, Cohn J B, Fabre L F, Claghorn J L, Dessain E C, Itil T M, Lautin A.
Double-blind, multicenter comparison of sertraline and amitriptyline in elderly depressed patients.
J. Clin. Psychiatry.
1990;
51 (suppl 12B)
28-33
-
9
Davis C S, Koch G G.
Some general methods for the analysis of categorical data in longitudinal studies.
Statistics in Medicine.
1988;
7
109-137
-
10
Doogan D P, Langdon C J.
A double-blind placebo-controlled comparison of sertraline and dothiepin in the treatment of major depression in general practice.
Int. Clin. Psychopharmacol..
1994;
9
95-100
-
11
Londborg P D, Wolkow R, Smith W T, DuBoff E, England D, Ferguson J, Rosenthal M, Weise C.
Sertraline in the treatment of panic disorder: a multi-site, double-blind, placebo-controlled fixed-dose investigation.
Brit. J. Psychiatry.
1998;
173
54-60
-
12
Fabre L F, Abuzzahab F S, Amin M, Claghorn J L, Mendels J, Petrie W M, Dube S, Small J G.
Sertraline safety and efficacy in major depression: a double-blind fixed-dose comparison with placebo.
Biol. Psychiatry.
1995;
38
592-602
-
13
Fawcett J.
Morbidity of clinical depression.
Int. Clin. Psychopharmacol..
1993;
8
217-220
-
14
Fischer-Cornelssen K A.
Multifokale Psychopharmakaprüfung (Multihospital Trial).
Drug Res..
1974;
24
1706-1724
-
15
Fournier J-P, Lane R M, Chouinard G, Watson D B, Amin M, Remick R A, Thorpe L U.
A double-blind comparison of sertraline and imipramine in outpatients with major depression. Acute (8 weeks) and continuation (16 weeks) treatment.
Hum. Psychopharm..
1997;
12
203-215
-
16
Greist J, Chouniard G, DuBoff E, Halaris A, Kim S W, Koran L, Liebowitz M, Lydiard R B, Rasmussen S, White K.
Double-blind parallel comparison of three dosages of sertraline and placebo in outpatients with obsessive-compulsive disorder.
Arch. Gen. Psychiatry.
1995;
52
289-295
-
17
Hamilton M.
A rating scale for depression.
J. Neurol. Neurosurg. Psychiatry.
1960;
23
56-62
-
18
Hyttel J.
Comparative pharmacology of selective serotonin reuptake inhibitors (SSRIs).
Nord. J. Psychiatry.
1993;
47 (suppl 30)
5-12
-
19
Kiloh L, Andrews G, Neilson M.
Long-term outcome of depressive illness.
Br. J. Psychiatry.
1988;
153
752-757
-
20
Lydiard R B, Stahl M S, Hertzman M, Harrison W M.
A double-blind, placebo-controlled study comparing the effects of sertraline versus amitriptyline in the treatment of Major Depression.
J. Clin. Psychiatry.
1997;
58
484-491
-
21
Möller H J, Gallinat J, Hegerl U, Arató M, Janka Z, Pflug B, Bauer H.
Double-blind, multicenter comparative study of sertraline and amitriptyline in hospitalized patients with Major Depression.
Pharmacopsychiatry.
1998;
31
170-177
-
22
Montgomery S A, Baldwin D, Green M.
Why do amitriptyline and dothiepin appear to be so dangerous in overdose?.
Acta Psychiatr. Scand..
1989;
Suppl. 80 (suppl 354)
47-53
-
23 National Institute of Mental Health .12-CGI: Clinical Global Impressions. Guy W (ed) EDCEU Assessment in Psychopharmacology, Rev Ed,. Rockville, Maryland; 1970: 217-222
-
24 Olie J P, Gunn K P, Katz E. Sertraline: efficacy and toleration in major depression. Presented at XIXth Collegium Internationale Neuropsycho-pharmacologicum, Washington DC, USA, 27 June - 1 July 1994
-
25
Preskorn S H, Lane R M.
Sertraline 50 mg daily: the optimal dose in the treatment of depression.
Int. Clin. Psychopharmacol..
1995;
10
129-141
-
26
Reimherr F W, Chouinard G, Cohn C K, Cole J O, LaPierre Y D, Masco H L, Mendels J.
Antidepressant efficacy of sertraline: a double-blind, placebo and amitriptyline-controlled, multicenter comparison study in outpatients with major depression.
J. Clin. Psychiatry.
1990;
51 (suppl 12B)
18-27
-
27 Salsburg D S. The use of restricted significance test in clinical trials. Springer Series in Statistics/Statistics in the Health Sciences 1992
-
28
Schatzberg A F.
Dosing strategies for antidepressant agents.
J. Clin. Psychiatry.
1991;
52 Suppl
14-20
-
29
Steinmeyer E M, Möller H J.
Facet theroretic analysis of the Hamilton-D scale.
J. Affect. Disord..
1992;
25
53-61
-
30
Walczak D D, Apter J T, Halikas J A, Borison R L, Carman J S, Post G L, Patrick R, Cohn J B, Cunningham L A, Rittberg B, Preskorn S H, Kang J S, Wilcox Ch.
The oral dose-effect relationship for fluvoxamine: a fixed-dose comparison against placebo in depressed outpatients.
Ann. Clin. Psychiatry.
1996;
8
139-151
-
31 Zung W WK. 072 DSI. Depression status inventory. In: W. Guy (ed.) ECDEU Assessment Manual for Psychopharmacology. Rockville, Maryland; 1976: 333-336
-
32 Zung W WK. 073 SDS. Self-rating depression scale. In: W. Guy (ed.) ECDEU Assessment Manual for Psychopharmacology. Rockville, Maryland; 1976: 333-336
Prof. Dr. med. H.-J. Möller
Direktor der Psychiatrischen Klinik und Poliklinik der Universität München Klinikum Innenstadt
Nußbaumstraße 7
80336 München
Germany
