schizophrenia
Conditions
Interventions
Product Name: Paliperidone Palmitate 25 mg
Pharmaceutical Form: Solution for injection
INN or Proposed INN: paliperidone palmitate
Current Sponsor code: R092670
Concentration unit: mg milligram(s)
Con
Sponsors
Janssen-Cilag International N.V
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female, age at least 18 or the minimum age to provide informed consent in the jurisdiction in which the study is taking place, whichever is greater, Met diagnostic criteria for schizophrenia according to DSM-IV(disorganized type [295.10], catatonic type [295.20], paranoid type [295.30], residual type [295.60], or undifferentiated type [295.90]) for at least 1 year before screening. A total PANSS score between 60 and 120, inclusive, at screening and baseline. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A primary, active DSM-IV diagnosis other than schizophrenia,A decrease of 25% in the PANSS score between screening and baseline as calculated using the table provided by the sponsor,A DSM-IV diagnosis of active substance dependence within 3 months before screening (nicotine and caffeine are not exclusionary.),
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate that paliperidone palmitate and RISPERDALCONSTA have comparable efficacy. The safety and tolerability of paliperidone palmitate inmaintenance therapy of schizophrenia will also be assessed.;Secondary Objective: Assessment of the global improvement in severity of illness associated with the use of paliperidonepalmitate compared with RISPERDAL CONSTAAssessment of the benefits to personal and social functioning associated with the use ofpaliperidone palmitate compared with RISPERDAL CONSTAEvaluation of symptomatic remission associated with the use of paliperidone palmitate comparedExploration of the pharmacokinetics of i.m. paliperidone palmitate and the relationship between itspharmacokinetics and the results of the efficacy parameters (e.g., Positive and Negative SyndromeScale [PANSS] and safety parameters (e.g., extrapyramidal symptoms [EPS] and adverse events of interest;Primary end point(s): Have received at least 3 injections of the double-blind medication (including the loading dose) and for whom the time between any 2 injections during the double-blind treatment period does not exceed 21 days, | — |
Countries
Czech Republic, Denmark, Estonia, Hungary, Lithuania, Spain, Sweden
Outcome results
None listed