P01-100 - Serenity: Evaluating the Effectiveness of GP-based Management of Atypical Antipsychotics in the Community

Objectives This SERENITY study was designed to investigate the effectiveness of atypical antipsychotics (AAPs) as defined by the three areas of patient functioning, efficacy and tolerability in general practice. Methods Between January 2007 and June 2008, 252 patients were enrolled, as planned, in this non-interventional study in Belgium. Inclusion criteria were patients 18-65 years old, willing and able to participate, diagnosed with Schizophrenia or Bipolar Disorder and currently in a manic episode and for whom the general practitioner (GP) decided to prescribe an AAP. Patient demographics, selection criteria, psychiatric and medical history and condition were assessed at Visit 1. Additional psychotropic drugs, name and dose of AAP, the QoL questionnaire Q-LES-Q-16, the Sheehan Disability Scale (SDS) for patient wellbeing, the Clinical Global Impression (CGI) and Patient Global Impression of Change (PGIC) scores for clinical efficacy and tolerability were assessed at Visit 1 (day 0), Visit 2 (week 4) and at Visit 3 (week 8). Results A mean change of 24.62 was observed in the Q-LES-Q results. The SDS total score decreased substantially with a mean change of -9.26. Number of days lost, and the number of unproductive days, at work or school decreased with a mean change of -1.88 and -2.31, respectively. CGI-S scores decreased by a mean -1.92 and the CGI-I and PGIC scores also decreased. A weak but positive correlation was seen between the medication satisfaction and the efficacy, tolerability and patients’ well-being. Conclusions This study indicates that GP-based management of antipsychotic treatment is effective in the community.