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European Neuropsychopharmacology | 2001

Short-term efficacy of tricyclic antidepressants revisited: A meta-analytic study

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

Erratum to “Short-term efficacy of tricyclic antidepressants revisited: a meta-analytic study”

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

Suicide Risk in Placebo-Controlled Studies of Major Depression

Jitschak G. Storosum; Barbara J. van Zwieten; Wim van den Brink; Berthold P. R. Gersons; André W. Broekmans


Schizophrenia Bulletin | 2002

Amisulpride: Is There a Treatment for Negative Symptoms in Schizophrenia Patients?

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

De klinische beoordeling van werkzaamheid en schadelijkheid bij de (Europese) registratie van geneesmiddelen: wat betekent dit voor de dokter en de patiënt?

P.P. Koopmans ; A. de Graeff; B.J. van Zwieten-Boot; J.F.F. Lekkerkerker; André W. Broekmans


American Journal of Psychiatry | 2002

Suicide risk in placebo-controlled studies - Dr. Storosum and colleagues reply

Jitschak G. Storosum; B. J. van Zwieten; W. van den Brink; Berthold P. R. Gersons; André W. Broekmans


American Journal of Psychiatry | 2002

Suicide risk in placebo-controlled studies. Authors' reply

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

Dr. Storosum and Colleagues Reply

Jitschak G. Storosum; Barbara J. van Zwieten; Wim van den Brink; Berthold P. R. Gersons; André W. Broekmans


Archive | 2001

Erratum to ''Short-term efficacy of tricyclic antidepressants revisited: a

Roel van Strik; André W. Broekmans


European Neuropsychopharmacology | 2001

Short-term efficacy of tricyclic antidepressants revisited: a meta-analytic study (vol 11, pg 173, 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

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