Injectable Paliperidone In Adults with Schizophrenia R092670SCH3005

• Research type

  Research Study

• Full title

  A 24-month, Prospective, Randomized, Active-Controlled, Open-Label,Rater-Blinded, Multicenter, International Study of the Prevention of Relapse Comparing Long-Acting Injectable Paliperidone Palmitate to Treatment as Usual with Oral Antipsychotics Monotherapy in Adults With Schizophrenia

• IRAS ID

  32055

• Contact name

  D S Gonzalez Naranjo

• Sponsor organisation

  Janssen-Cilag International N.V.

• Eudract number

  2008-002247-16

• ISRCTN Number

  n/a

• Research summary

  Approximately 766 subjects with recently diagnosed schizophrenia (1 to 5 years since diagnosis) and suffering from a relapse will be enrolled in this study. The study will compare Paliperidone Palmitate given by injection to "treatment as usual" with antipsychotic medicines which taken by mouth, in the prevention of relapse. The choice of the oral treatment is at the investigators' discretion. Subjects will be randomly assigned to receive Paliperidone Palmitate injection (once-monthly) or oral antipsychotic medication until relapse or up to a maximum of 24 months, whichever comes first. The oral treatment arm consists of 6 oral antipsychotics, i.e. oral haloperidol and the 5 atypical antipsychotics Paliperidone ER, Risperidone, olanzapine, Quetiapine and Aripiprazole. Three groups of oral treatments will be created, each containing haloperidol plus 4 atypical antipsychotics: 1 Olanzapine, Risperidone, Quetiapine, Aripiprazole and haloperidol 2 Olanzapine, Paliperidone ER, Quetiapine, Aripiprazole and haloperidol 3 Risperidone, Paliperidone ER, Quetiapine, Aripiprazole and haloperidol Countries will be allocated to one of these 3 groups based on the commercial availability of the comparator drugs in the respective country. The UK has been allocated to group 1. The primary endpoint will be the time to relapse. Safety will be monitored by evaluating adverse events, symptom scores, and physical signs/symptoms.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  10/H0605/4

• Date of REC Opinion

  25 Feb 2010

• REC opinion

  Further Information Favourable Opinion