title: A prospective, multicentre, open-label study of aripiprazole in the management of patients with schizophrenia in psychiatric practice in Europe: Broad Effectiveness Trial with Aripiprazole in Europe (EU-BETA).
abstract: OBJECTIVE
  To examine the effectiveness of aripiprazole in schizophrenia in a naturalistic setting in 14 European countries.
  
  
  METHODS
  This multicentre, open-label study of aripiprazole evaluated outpatients with schizophrenia for whom a medication switch was clinically reasonable or antipsychotic initiation was required. Patients (n = 833) were randomized in a 4:1 ratio to aripiprazole (recommended starting dose 15 mg/day, permitted adjustment 10-30 mg/day) (n = 680) or another antipsychotic (safety control [SC] group) (n = 153) for 8 weeks. The control group received an antipsychotic different to their recent pre-study medication. The primary effectiveness measure was the Clinical Global Impression - Improvement (CGI - I) score of aripiprazole-treated patients at Week 8 (last observation carried forward [LOCF]). Patients' and caregivers' medication preference was assessed using the Preference of Medication (POM) questionnaire. The Investigator Assessment Questionnaire (IAQ) was used to record investigators' assessments of their patients' responses to the study antipsychotic. Adverse events (AEs) were recorded.
  
  
  RESULTS
  At endpoint (Week 8, LOCF), the mean CGI - I score of 3.16 (95% confidence interval, [CI]: 3.04, 3.28) demonstrated the effectiveness of aripiprazole. At endpoint, 43% of aripiprazole-treated patients showed a response (CGI - I score = 1/2). Aripiprazole was rated as slightly or much better than previous antipsychotic at endpoint by 68% of patients and 65% of caregivers. The mean CGI - I score (Week 8, LOCF) for the SC group was 3.37 (95% CI: 3.14, 3.60). No major differences in the occurrence of AEs were noted between aripiprazole- and SC-treated patients.
  
  
  CONCLUSIONS
  As this is an open-label design, there may have been a bias. Secondly, the study was not powered to show differences between treatment groups and no statistical comparisons were planned. Thirdly, 8 weeks is too short to evaluate long-term effectiveness.
  
  
  CONCLUSIONS
  Aripiprazole was effective, well tolerated and well accepted by patients and caregivers in this naturalistic study.
authors: Department of Psychiatry, Charité - University Medicine Berlin, Campus Benjamin Franklin, Berlin, Germany. Juergen.wolf@abw-zh.ch
authors: Jürgen
authors: J
authors: Wolf
authors: Firmin
authors: F
authors: Janssen
authors: Henrik
authors: H
authors: Lublin
authors: Raimo K R
authors: RK
authors: Salokangas
authors: Hervé
authors: H
authors: Allain
authors: Enrico
authors: E
authors: Smeraldi
authors: Miguel
authors: M
authors: Bernardo
authors: Helen
authors: H
authors: Millar
authors: Miranda
authors: M
authors: Pans
authors: Christine
authors: C
authors: Adelbrecht
authors: Jim
authors: J
authors: Laughton
authors: Christian
authors: C
authors: Werner
authors: Wolfgang
authors: W
authors: Maier
mesh_terms: D014150:Antipsychotic Agents / Q000627:therapeutic use*; D000068180:Aripiprazole; D005060:Europe; D006801:Humans; D010879:Piperazines / Q000627:therapeutic use*; D011446:Prospective Studies; D015363:Quinolones / Q000627:therapeutic use*; D012559:Schizophrenia / Q000188:drug therapy*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D010879:Piperazines; D015363:Quinolones; D000068180:Aripiprazole