ARRIVE - Aripiprazole or Antipsychotics as treatment in Schizophrenia

• Research type

  Research Study

• Full title

  A Multicenter, Open-label Study to Assess Hospitalization Rates in Adult Subjects with Schizophrenia Treated Prospectively for 6 Months with Aripiprazole IM Depot Compared with 6-month Retrospective Treatment with Oral Antipsychotics in a Naturalistic Community Setting in Europe, Canada, and Asia.

• IRAS ID

  87984

• Contact name

  Eleni Palazidou

• Sponsor organisation

  Otsuka Pharmaceutical Development & Commercialization, Inc.

• Eudract number

  2011-003850-26

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  Schizophrenia is a chronic condition that requires continual treatment to maintain adequate cognitive and social functioning. This study is a Phase 3b, multicenter, open-label, 6-month retrospective followed by 6-month prospective trial to assess the inpatient psychiatric hospitalization rates of patients receiving oral standard of care (6-month retrospective hospitalisation[s]) and that of subjects receiving once monthly aripiprazole IM depot injections prospectively for 6 months (6 months prospective hospitalisation[s]). This trial will include male and female subjects aged 18 to 65 years of age, inclusive, with a diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria. The primary endpoint of this trial is the comparison of inpatient psychiatric hospitalization rates (proportion of subjects with >1 inpatient psychiatric hospitalisation[s]) between the retrospective period Months 4-6 (Weeks -12 to -24) while on oral standard of care antipsychotic treatment and the prospective period Phase B Months 4-6 (Weeks 12 to 24) after switch to aripiprazole IM depot.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  11/EE/0471

• Date of REC Opinion

  30 Jan 2012

• REC opinion

  Further Information Favourable Opinion