Target concentration intervention (TCI) represents a method for optimizing pharmacological
therapy that differs from therapeutic drug monitoring (TDM) by the determination of
target plasma levels. The therapeutic range (TDM) is replaced by individually ascertained
plasma concentrations (TCI) reflecting both optimal clinical effectiveness and maximum
tolerability (Holford 2003).
In a naturalistic study 34 in-patients suffering from depressive disorders (according
to ICD-10 diagnostic criteria) were investigated. The patients received the antidepressant
mirtazapine (NaSSa) which selectively acts on noradrenergic-serotonergic system and
for which a rapid onset of the desired effects is described. The hypothesis whether
a better therapeutic effect was achived by utilizing a modified TCI was examined.
By means of the HPLC method mirtazapine plasma levels were determined at different
times. In the laboratory patients were randomly distributed to a group with and one
without TCI, whereby the patients with TCI were assigned a plasma level range of 40
ng/ml. Mirtazapine was dispensed according to laboratory recommendations (with TCI)
or by clinical assessment (without TCI). The severity of the depressive symptoms was
recorded at the beginning and during the course of the observation with the Hamilton
Depression scale (HAMD-21) and the final assessment was concluded with clinical global
impression (CGI).
The results are presented in the workshop.