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Abstracts of the Invited Speakers<br />

[JS-06]<br />

Czech NeuroPsychopharmacological Society (CNPS)<br />

Symposium title: From models of schizophrenia to clinical outcome: A psychopharmacological perspective<br />

Safety first, efficacy second? Fear and the need for treatment in the absence of controlled data<br />

Pavel Mohr, David Hnidek, Dagmar Seifertova<br />

Prague Psychiatric Center, Czech Republic<br />

E-mail: mohr@pcp.lf3.cuni.cz<br />

In clinical practice, physicians are routinely asked to make decisions about whether to initiate or continue antidepressant treatment in<br />

a situation where no safety data are available. Pregnancy and breast-feeding can serve as an example, where controlled clinical trials<br />

provide little guidance. Females of fertile age are rarely included in the early phases of clinical testing, indeed, Phase IIb and III trials have<br />

a standard provision to use a reliable method of contraception. Pregnancy during a drug trial is considered as a ‘serious adverse event’<br />

with subsequent study discontinuation. The reasons are not just ethical and legal but also marketing, including the drug manufacturers’<br />

fear of having their products associated with potentially grave side effects, such as malformations. Drug treatment in pregnancy and<br />

lactation thus pose a highly relevant clinical problem that cannot be addressed in controlled trials. Excessive concerns of negative<br />

consequences could erroneously result in a generalized recommendation to not get pregnant or to abort an existing pregnancy. However,<br />

the fetus may already have been exposed to drugs early in the first trimester during frequently unplanned pregnancies; in addition, recent<br />

epidemiological data indicate increasing consumption of psychotropics, including antidepressants, by pregnant women. Psychiatrists<br />

have to weigh the known risks of treatment discontinuation versus the potential risks for the fetus and infant. They should also consider<br />

whether alternative non-pharmacological interventions (psychotherapy, ECT, rTMS) are accessible or effective. The only available safety<br />

data on antidepressants come from animal studies, epidemiological trials, drug registries, case series, anecdotal case vignettes and clinical<br />

observations.<br />

Moreover, published findings have to be viewed with caution and interpreted correctly. For example, recent data suggested an increased<br />

teratogenic risk for the antidepressant paroxetine. While it is true that a meta-analysis confirmed an increased relative incidence of<br />

malformations, the absolute risk was raised from 3% to 4% for all congenital malformations and from 1% to 2% for cardiac malformations.<br />

In 2005 the Prague Psychiatric Center established a specialized consultation outpatient center for pharmacotherapy in pregnancy and<br />

breastfeeding. The center provides services and information on safety and treatment recommendations directly to patients, their treating<br />

psychiatrists and other physicians as well. The database consists of patients records, data on their illness, treatment and pregnancy<br />

outcome. Currently, a prospective study for the longitudinal follow-up of offspring exposed in utero to psychotropics has been designed.<br />

The focus is on their developmental milestones, physical health, neuropsychological performance and general well-being.<br />

Key words: Psychotropic drugs, pregnancy, lactation, drug safety, psychiatric disorders<br />

Bulletin of Clinical Psychopharmacology 2011;21(Suppl. 2):S48<br />

Basic concepts of schizophrenia: Experimental approaches<br />

Cyril Höschl 1<br />

1Prague psychiatric centre, Centre of neuropsychiatric studies,<br />

3rd Medical faculty, Charles University, Prague, Czech Rep.<br />

E-mail: hoschl@pcp.lf3.cuni.cz<br />

One of the crucial questions in the study of schizophrenia is, whether the diagnosis of the disease represents one entity or a group of<br />

disorders (“Gruppe der Schizophrenien”). Nancy Andreasen suggests the term “lathomenology” for a bottleneck on the pathogenetic way<br />

from various possible etiological factors to diverse phenomenological expressions (symptoms) (Arch Gen Psych 1999;56:781-787). In the<br />

background of this common denominator, there is an anatomical and functional disruption in neuronal connectivity and communication,<br />

which can be a consequence of incomplete or erroneous neuron formation, migration, synaptogenesis or pruning during ontogenesis.<br />

Also apoptosis and activity dependent changes might play a role in this development. This all can happen from conception to early<br />

adulthood and can lead to the impairment in fundamental cognitive functions. This leads to the development of clinical symptoms,<br />

either positive or negative. Schizophrenia can be regarded as a “disconnection” or “information processing disorder”. There are many<br />

S48 Bulletin of Clinical Psychopharmacology, Vol: 21, Supplement: 2, 2011 - www.psikofarmakoloji.org

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