André W. Broekmans
Utrecht University
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European Neuropsychopharmacology | 2001
Jitschak G. Storosum; Andre J. A. Elferink; Barbara J. van Zwieten; Wim van den Brink; Berthold P. R. Gersons; Roel van Strik; André W. Broekmans
The original data from the placebo-arms and the tricyclic-arms of all parallel randomized controlled three-arm studies, which had been conducted in the period 1979-1991 for a drug under development in order to obtain marketing authorization for the indication major depression, were included in a meta-analysis. Thirty-two placebo-controlled studies including 4314 patients were analyzed. The intention to treat analysis resulted in 46% responders (at least 50% improvement on the Hamilton Depression Rating Scale) in the tricyclic antidepressant group and 31% in the placebo-group (CI(95%-difference) 11.5-17.1%). The number needed to treat for responders was 7 (CI(95%) 5-8). In 10 out of 32 studies, a statistically significant difference in favor of tricyclic antidepressant compared to placebo was found for responders. The responder rate in the placebo-group varied from 6 to 52%. We conclude that tricyclic antidepressants are efficacious in the short-term treatment of major depression. However, the magnitude of the effect is rather modest. Because 69% of the placebo-controlled studies with a tricyclic antidepressant did not show a statistically significant difference in favor of tricyclic antidepressant and the placebo rate varied considerably from study to study, equivalence studies with tricyclic antidepressant as comparator without a placebo-control are not sufficient for demonstrating efficacy. Therefore in major depression, placebo-controlled studies are still necessary to demonstrate efficacy.
European Neuropsychopharmacology | 2001
Jitschak G. Storosum; Andre J. A. Elferink; Barbara J. van Zwieten; Wim van den Brink; Berthold P. R. Gersons; Roel van Strik; André W. Broekmans
Kirsch, I., Sapirstein, G., 1998. Listening to prozac but hearing placebo: a clinically useful measures of the consequences of treatment. N. Engl. J. meta-analysis of antidepressant medication. Prev. Treat. (http. / / jourMed. 318, 1728–1733. nals.apa.org /prevention /volume1/pre001002a.html). Montgomery, S.A., 1995. Clinical relevance of response and improveKlein, D.F., Gittelman, R., Quitkin, F., Rifkin, A., 1980. In: 2nd Edition. ment in psychopharmacology. A statement from the European College Diagnosis and Drug Treatment of Psychiatric Disorders: Adults and of Neuropsychopharmacology, from an ECNP workshop, Jerusalem, Children. Williams and Wilkins, Baltimore. October 1995. Eur. Neuropsychopharmacol. 5, 511–533. Kuhn, R., 1958. The treatment of depressive states with G-22355 Rothman, K.J., Michels, K.B., 1994. The continuing unethical use of (imipramine hydrochloride). Am. J. Psychiatry 115, 459–464. placebo controls. N. Engl. J. Med. 331, 394–398. Laupacis, A., Sackett, D.L., Roberts, R.S., 1988. An assessment of
American Journal of Psychiatry | 2001
Jitschak G. Storosum; Barbara J. van Zwieten; Wim van den Brink; Berthold P. R. Gersons; André W. Broekmans
Schizophrenia Bulletin | 2002
Jitschak G. Storosum; Andre J. A. Elferink; Barbara J. van Zwieten; Roel van Strik; Witte J.G. Hoogendijk; André W. Broekmans
Nederlands Tijdschrift voor Geneeskunde | 2000
P.P. Koopmans ; A. de Graeff; B.J. van Zwieten-Boot; J.F.F. Lekkerkerker; André W. Broekmans
American Journal of Psychiatry | 2002
Jitschak G. Storosum; B. J. van Zwieten; W. van den Brink; Berthold P. R. Gersons; André W. Broekmans
American Journal of Psychiatry | 2002
Robert D. Goldney; Jitschak G. Storosum; Barbara J. van Zwieten; Wim van den Brink; Berthold P. R. Gersons; André W. Broekmans
American Journal of Psychiatry | 2002
Jitschak G. Storosum; Barbara J. van Zwieten; Wim van den Brink; Berthold P. R. Gersons; André W. Broekmans
Archive | 2001
Roel van Strik; André W. Broekmans
European Neuropsychopharmacology | 2001
Jitschak G. Storosum; Andre J. A. Elferink; B. J. van Zwieten; W. van den Brink; Berthold P. R. Gersons; R. van Strik; André W. Broekmans