An Open Label Multicentre Study to Determine the Dose Distribution of Paliperidone ER in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to evaluate the dose distribution, effectiveness and safety in
      patients with schizophrenia who are switched from an oral atypical antipsychotic to
      Paliperidone ER. In this study patients and physicians know the name and the dose of the
      study drug. Newly diagnosed patients will also be included in the study. In general, the
      recommended Paliperidone ER dose will be 6 mg once daily, however some patients may require a
      higher or lower initial dose in the recommended range of 3 to 12 mg once daily. The dose can
      be adjusted any point during the study, to a maximum dose of 12mg/day. Flexible dosing was
      chosen to best mimic actual clinical practice.The safety assessments to be conducted
      throughout this study including the regular monitoring and recording of all Adverse Events
      and Serious Adverse Events.
    

Detailed description: 
      This trial is a non-randomised (both patient and physician know the study drug), single arm,
      open label multicentre study which is aimed to evaluate the dose distribution, efficacy and
      safety in patients with schizophrenia who are switched from an oral atypical antipsychotic to
      Paliperidone ER. Newly diagnosed patients will also be included in the study. In general, the
      recommended Paliperidone ER dose will be 6 mg once daily, however some patients may require a
      higher or lower initial dose in the recommended range of 3 to 12 mg once daily. The dose can
      be adjusted any point during the study, to a maximum dose of 12mg/day. Flexible dosing was
      chosen to best mimic actual clinical practice.The study duration will be split into two
      phases. Phase A will be 12 weeks and Phase B which will be an optional follow up phase will
      be 40 weeks. Assessment of efficacy and safety will be performed in Phase A at baseline, 2,
      4, 6, 9 and 12 weeks and in Phase B at 20, 28, 36, 44 and 52 weeks. At the first visit, a
      full psychiatric history, demographic data and physical examination will be undertaken.
      Throughout the study, the following procedures, documentations and evaluations will be
      performed: descriptions of concomitant medications; hospitalisations for psychiatric reasons;
      clinical deterioration; Clinical Global Impression - Severity (CGI-S) and Global Assessment
      of Functioning (GAF) assessments; Community Treatment Order (CTO) status; weight; adherence
      and adverse event reporting. Physical examinations will be performed periodically.
      Paliperidone ER OROS will be supplied in 3 mg, 6 mg, and 9 mg tablets for oral
      administration. In general, the recommended Paliperidone ER dose will be 6 mg once daily,
      however some patients may require a higher or lower initial dose in the recommended range of
      3 to 12 mg once daily. The dose can be adjusted any point during the study, to a maximum dose
      of 12mg/day. The study duration will be split into two phases. Phase A will be 12 weeks and
      Phase B which will be an optional follow up phase
    

Intervention name(s): Paliperidone
Intervention type(s): Drug
Intervention description(s): 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
Intervention MeSH terms: Paliperidone Palmitate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Drug Therapy; Treatment Outcome