A Double Blind Out Patient Comparative Trial of Indalpine Versus Mianserin
Indalpine, inhibits the re-uptake of 5HT but it is obvious that there is no single agreed hypothesis to explain depression. Whatever the proposed mechanism of action of an antidepressant, the main question for the clinician is “is the drug an effective and safe antidepressant in clinical practice,” and the following trial was carried out to determine Indalpine’s efficacy by comparing it to an established antidepressant. This design was chosen because of the ethical difficulties of placebo controlled out-patient trials but it is scientifically the weaker design because the null hypothesis is then that the two drugs are equally effective and failure to reject this hypothesis may be the result of a poorly designed trial, too small numbers, etc. Thus one does not prove the two drugs to be similar, one simply fails to prove that they differ. Despite such difficulties, however, double blind control trials are essential tools for the assessment of a new antidepressant and many such trials are necessary before the effectiveness of a drug can be said to be established. With placebo effect and observer bias, open trials are unsuitable for assessing such drugs.
KeywordsWhite Cell Count Global Rating Scale Double Blind Control Trial Abnormal Liver Enzyme Weak Design
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