[New exigencies for new antidepressive agents].
Preclinical trials are mainly concerned with toxicologic and behavioral studies in animals. Clinical trials, in man, require answers to several key-questions: confirmation of the superiority of the compound versus placebo, short, middle, and long-term studies for evaluation of efficacy and safety, international clinical criteria defining the experimental population, research of drug interactions, studies within specific types of population, especially ageing subjects. Heterogeneity of information, for the new antidepressive compounds, is explained by several factors: prescription to out- or in-patients, by general practitioners or specialists. The Marketing Authorization Committee and another committee called "Commission de transparence" assess the risk-benefit ratio, the indications of the drug (acute depressive reaction, prophylaxis of recurrences...), the medical benefit. But these advances in methodological procedures are questionable. Will they allow new discoveries, or, conversely, counteract an inventive clinical practice?
Hôpital Paul Brousse, Villejuif.
D
D
Ginestet
J P
JP
Olié
D000818:Animals; D000928:Antidepressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D003866:Depressive Disorder / Q000188:drug therapy* / Q000523:psychology; D017277:Drug Approval; D006801:Humans; D008134:Long-Term Care; D016896:Treatment Outcome
D000928:Antidepressive Agents
Nouvelles exigences pour les nouveaux antidépresseurs.