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Retrospective, observational, post-authorization study to obtain a second profile of schizophrenic patients treated with aripiprazole in Spain. Study REA II

Published online by Cambridge University Press:  16 April 2020

F. Cañas
Affiliation:
Hospital Dr. Rodríguez Lafora, Madrid, Spain
M. Camacho
Affiliation:
Hospital Virgen de la Macarena, Sevilla, Spain
S. Ros
Affiliation:
Hospital del Mar, Barcelona, Spain
M. Serrano
Affiliation:
Hospital Juan Canalejo, La Coruña, Spain
Y. Riesgo
Affiliation:
Medical Department BMS, Madrid, Spain
P. Hernanz
Affiliation:
Medical Department BMS, Madrid, Spain
P. Vieitez
Affiliation:
Medical Department BMS, Madrid, Spain

Abstract

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Introduction:

The conditions for the use of study medications are different in a clinical trial than when the same drugs are marketed and administered to larger population groups. This study was proposed after the recent change in the range of doses marketing of Aripiprazole in our country and following a change in the range of doses used.

Objectives:

To identify the type of patients treated with aAripiprazole during 4 months (May 06) after the change in the SmPC (10-30 mg dose) and to establish the doses used. To identify the proportion of patients switching to aAripiprazole from previous antipsychotic treatments due to reduced efficacy or low tolerance to the previous drugs.

Patients and Methods:

This is a retrospective, observational, multicenter study. Data will be collected from the medical records of 1000 patients treated with aAripiprazole during the four months prior to the study initiation, with a minimum of 1 month treatment. The information will be gathered by 200 psychiatrists each one providing 5 cases. Data collection was initiated in October 2006 and is expected to last two months. The sample size based on the primary objective obtained will enable a 95% confidence interval with a maximum acceptable error of 3% to estimate the proportion based on the primary objective.

Conclusions:

The collection of data will enable us to know how psychiatrists prescribe aAripiprazole, considering the type of patient, dosage regime, switching strategy of antipsychotic treatment (by identifying the ratios of treatment switches) under standard conditions of use.

Type
Poster Session 1: Schizophrenia and Other Psychosis
Copyright
Copyright © European Psychiatric Association 2007
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