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The idea of placebo-controlled drug trials and the advent of test
statistics during the first part of this century were the major
milestones in the establishment of a convincing methodology for
demonstrating the efficacy of treatments. The first tricyclic and
neuroleptic drugs were tested for their efficacy in psychiatric
disorders along the lines of these methodological developments, but
subsequent trials with psychotropic drugs did not adhere to these
principles to the same extent because it became difficult to
justify placebo-controlled trials once effective treatments had
been established. Consequently, the second generation of an
tidepressants and neuroleptics (since the early 1960s) were mainly
tested, in Europe at least, in samples of patients using trials
controlled by standard treatment only, and the methodological basis
of these second generation trials became fragile, as will be
demonstrated by several papers in this book. This development did
not provoke much discussion until recently, when scientific and
administrative interest in the methodology of the evaluation of
psychotropic drugs increased substantially. A series of factors
contribute to the growing interest in the standards of psychotropic
drug trials: 1. The proportion of psychiatric patients resistant to
treatment is growing; the efficacy of well-established forms of
treatment therefore seems to be limited. 2. A series of
psychotropic drugs were withdrawn from the market, mainly because
they caused serious side effects. The efficacy and safety ofthese
drugs had previously been demonstrated in drug trials, which raised
the question whether the drug trials carried out were
well-designed."
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