Methods and Findings in Experimental and Clinical Pharmacology
Vol. 25, Suppl. A, 2003
ISSN 0379-0355
Copyright 2003 Prous Science, S.A.
CCC: 0379-0355/2003
http://www.prous.com

Phase III Clinical Trials in Psychiatry

A. González-Pinto

Department of Psychiatry, Hospital Santiago, Vitoria, Spain

Randomized controlled clinical trials have been the gold standard for obtaining information on how psychiatric treatments affect health. Clinical trials evaluate efficacy, but achieving this goal often requires testing treatments under ideal or best-practice conditions. This represents an important step toward determining the desirability of implementing a treatment in practice. However, due to features of design and implementation, Phase III clinical trials have important limitations regarding clinical practice and policy decisions about treatments. The EMEA is a regulatory body that provides the institutions of the European Community with the best possible advice on the quality, safety and efficacy of medicinal products. The EMEA recommends clinical trials to detect a difference between the compound under investigation and placebo, and to assess at least non-inferiority against an active comparator. The EMEA supports the use of placebo only when there is no serious risk for the patient. In psychiatry, and specifically in schizophrenia, depression and bipolar disorder, the Agency suggests that a three arm study is the design of choice, to demonstrate superiority against placebo and a similar balance against the active comparator (1). As major psychiatric disorders are severe diseases, patients recruited in clinical trials do not represent the patients seen in clinical practice. Yastrubetskaya et al. (2) found that only 4.2% of the elderly patients with major depression seen in their clinical practice met the rigorous inclusion/exclusion criteria of a Phase III study. Indeed, it is more difficult to include patients in clinical trials of bipolar disorder. Phase III clinical trials often require drug-free, moderately symptomatic, acutely non-suicidal patients (3). Therefore, this potentially limits the generalization of the results of these trials.

ACKNOWLEDGMENTS

The Research Psychiatric Unit in Santiago Apóstol Hospital has received a Stanley Research Center grant (03-RC-003) and another grant from F.I.S (Fondo de Investigación Sanitaria. Ministerio de Sanidad y Consumo: PI021297)

REFERENCES

1. Guaiana, G., Barbui, C. A systematic review of the European Agency for the evaluation of medicinal products (EMEA) recommendations on the conduct of clinical trials in psychiatry. Epidemiol Psychiatr Soc 2002, 11: 28-34.

2. Yastrubetskaya, O., Chiu, E., O'Connell, S. Is good clinical research practice for clinical trials good for clinical practice? Int J Geriatr Psychiatry 1997, 12: 227-31.

3. Rush, A.J., Post, M.R., Nolen, W.A. et al. Methodological Issues in developing New acute treatments for patients with bipolar disorder. Biol Psychiatry 2000, 48: 615-24.

Methods and Findings in Experimental and Clinical Pharmacology Vol. 25, Suppl. A, 2003
ISSN 0379-0355 Copyright 2003 Prous Science, S.A. CCC: 0379-0355/2003 http://www.prous.com