Methodology of the Evaluation of Psychotropic Drugs by K. Rickels (auth.), Professor Dr. med. Otto Benkert,

By K. Rickels (auth.), Professor Dr. med. Otto Benkert, Priv.-Doz. Dr.med. Wolfgang Maier, Karl Rickels M.D. (eds.)

The thought of placebo-controlled drug trials and the appearance of try out records throughout the first a part of this century have been the most important milestones within the institution of a resounding method for demonstrating the efficacy of remedies. the 1st tricyclic and neuroleptic medications have been established for his or her efficacy in psychiatric issues alongside the strains of those methodological advancements, yet next trials with psychotropic medicinal drugs didn't adhere to those rules to an analogous volume since it turned tough to justify placebo-controlled trials as soon as potent remedies were demonstrated. as a result, the second one iteration of an­ tidepressants and neuroleptics (since the early Sixties) have been as a rule proven, in Europe at the least, in samples of sufferers utilizing trials managed by means of common remedy purely, and the methodological foundation of those moment iteration trials grew to become fragile, as might be proven by means of a number of papers during this e-book. This improvement didn't galvanize a lot dialogue until eventually lately, while medical and administrative curiosity within the method of the review of psychotropic medicinal drugs elevated considerably. a sequence of things give a contribution to the turning out to be curiosity within the criteria of psychotropic drug trials: 1. the share of psychiatric sufferers immune to therapy is turning out to be; the efficacy of well-established kinds of therapy as a result looks constrained. 2. a chain of psychotropic medicines have been withdrawn from the marketplace, in general simply because they triggered critical unwanted side effects. The efficacy and security ofthese medicinal drugs had formerly been validated in drug trials, which raised the query no matter if the drug trials performed have been well-designed.

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1986; Hirsch et al. 1973). 5 Modified Acute Placebo-Controlled Design We have developed a modification of the placebo-controlled design which we have found overcomes most of the objections to the use of placebos in acute clinical studies but retains most ofthe advantages (Manchanda and Hirsch 1986). We had wanted to establish whether propranolol has any pharmacological effect on the symptoms of acute schizophrenia, using a standard placebo-controlled trial design. However, as stated above we had only recruited two patients in 18 months.

This was the result of a 7-year follow-up study we carried out of an earlier placebo substitution study which first determined the efficacy of fluphenazine decanoate depot medication in the late 1960s (Curson et al. 1986; Hirsch et al. 1973). 5 Modified Acute Placebo-Controlled Design We have developed a modification of the placebo-controlled design which we have found overcomes most of the objections to the use of placebos in acute clinical studies but retains most ofthe advantages (Manchanda and Hirsch 1986).

Dosage equivalents of neuroleptics have been determined by a number of methods, including in vitro studies of their potency in blocking H3 spiroperidol binding (Creese et al. 1976; Seeman et al. 1976), differences in their tendency to cause extrapyramidal side effects, and the dosage of the drug which has proved effective in establishing the drug's treatment superiority over placebo as a ratio to the corresponding dosage of chlorpromazine (Davis 1976). However, these three methods do not correlate so well that one can view them as interchangeable and each leads to slightly different determinations of dosage equivalents.

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