XI Congresso della Società Italiana di Psicopatologia Psichiatria ...

POSTER
was necessary in order to test the efficacy of a new drug,
but, more surprisingly, only 20% of them knew the existence
of a French law passed in order to protect the rights of
the subjects involved in a clinical trial! From an ethical
point of view, coming from the Hippocratic writings, three
principles are fundamental in the patient-physician relationship:
1. the principle of Good Will (“I will come for the benefit
of the sick”) and of Not Ill Will (“First, do not harm”);
2. the principle of Justice (“insuring that the patients bearing
the greatest burden for research also benefit from it” 1 ; 3.
the principle of the Respect of the Person (“People have the
right to health and health care” (art. 32 of the Italian Constitution
and arts. II-63 e II-95 of the European Constitution).
Because the decisional capacity or competence could
be impaired by a severe acute episode of a given disorder, a
so called Psychiatric Will of anticipated directive expressed
by the patient, could be a way to overcome a temporary state
of non-competence. A Consent Auditor, to testify and control
the process of consent could be of some help and lastly
the Local Ethics Committee should guarantee a deep and
careful examination of the tests of the informed consent and
the monitoring of the ongoing clinical trial. Some methodological
suggestions have been published in order to ameliorate
the comprehension and the effectiveness of a consent:
1. use of “open ended questions” and avoidance of
“close ended questions”; 2. give time to the patient to think
about the proposal of taking part in the trial; 3. pay attention
to the language used: it has to be clear and not too “medical”;
4. invite the patient to discuss the form of the consent
and the study information sheet with his relatives, his general
practitioner or “other relevant people” to obtain opinion,
clarification and support about his decision to participate
in the study.
The informed consent should explain to the patient the plan
of the study (visits, laboratory tests), how many patients
have been treated before him, that the confidentiality of sensitive
personal data is respected, the known risks and adverse
effects of the study drugs, the possibility of unknown
risks, the possible alternative treatments available and the
complete liberty of his participation. Vulnerable subjects
should not be involved in trials (even if methodologically
well designed) where the benefit for the patients is not guaranteed
(for example in dose finding studies or in studies
where the placebo is used). In vulnerable categories of subjects
(children, elderly, psychiatric and oncologic patients) it
is extremely difficult to make them accept the concept of
collective benefit of the “experimental” studies over the individual
and personal benefit due to the “therapeutic” studies.
It is not right because it could be a therapeutic misconception.
For them the individual benefit must always prevail
over collective benefit.
Furthermore, because of the large choice of active medications
in psychiatric disorders and the well documented protective
role of the pharmacotherapy in the evolution of the
disorders, the use of the placebo must be limited or, even
better, avoided. In accordance to the last version of the Declaration
of Helsinki 3 the use of the placebo is justified in a
very narrow range of situations, first of all when a standard
treatment of proven efficacy for a given pathological condition
does not exist. The use of the placebo could be tolerated
when a double dummy design is requested but all the patients
are guaranteed to be treated with an active medication
and when the duration of the placebo treatment is very short
(wash out or run-in periods).
References
1 Wiess Roberts L, Dyer AR. Ethics in Mental Health Care. Washington,
DC: Am Psych Pub 2004.
2 Gerard-Coue MG, Rouillon F, Dreyfus JD. Survey for participation
in therapeutic trial in psychiatry. Encephale 1994;20:421-6.
3 Declaration of Helsinki, 52 nd General Assembly of the WMA
(Edimburgh, 2000).
160. Quetiapina: tollerabilità e sicurezza
ad alti dosaggi
P. Mainini, B. Ragni
Dipartimento di Salute Mentale Nord, ASL 13, Novara
Introduzione: l’efficacia e la tollerabilità della quetiapina
in campo psichiatrico è confermata da tempo a livello internazionale.
L’uso presso la nostra struttura e l’osservazione
dei pazienti in terapia con quetiapina in questi ultimi tre anni
hanno permesso di evidenziare la scarsità di effetti collaterali
anche a dosaggi elevati. Partendo da questi presupposti
si è attuato uno studio allo scopo di evidenziare la tollerabilità
di quetiapina anche a dosaggi superiori al range di
scheda tecnica, dosaggi motivati dal quadro clinico presentato
dal paziente.
Metodologia: lo studio di tipo osservazionale prospettico è
stato condotto da gennaio a settembre 2005; sono stati inclusi
un totale di 14 pazienti, 12 con diagnosi di schizofrenia, 2 con
diagnosi di psicosi isterica. I dosaggi utilizzati erano compresi
in un range di 900-1200 mg die; la titolazione è stata rapida,
con monitoraggio della pressione arteriosa, della frequenza
cardiaca, del QT, del peso e dei parametri ematici.
Risultati: i risultati hanno confermato l’estrema tollerabilità
della molecola, non sono state infatti evidenziate differenze
significative sugli effetti collaterali rispetto ai dosaggi più
bassi. La tollerabilità stessa ha permesso una totale aderenza
al programma terapeutico con una totale compliance alla
terapia stessa.
Bibliografia
Pancheri P, a cura di. Farmacoterapia psichiatrica. 2003.
Tasman A, Key J, Lieberman JA. Psychiatry. 2005.
161. Duloxetina nel trattamento a lungo
termine della depressione maggiore
M. Mancini, A. Barraco, A. Rossi
Ely Lilly Italia S.p.A.
Obiettivi: la depressione maggiore (DM) è una patologia
cronica ricorrente e le linee guida raccomandano la terapia
a lungo termine. Questo studio ha valutato, in pazienti con
depressione maggiore (DSM-IV), la sicurezza e l’efficacia
della terapia a lungo termine (1 anno) con duloxetina, inibitore
della ricaptazione di serotonina e di noradrenalina.
Metodi: studio multinazionale, in aperto, in pazienti ambulatoriali
(età minima 18 anni) che ricevevano duloxetina da
80 mg/die a 120 mg/die per 1 anno.
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