Schizophrenia according to DSM-IV-TM [disorganized type (295.10), catatonic type (295.20), paranoid type (295.30), residual type (295.60) or undifferentiated type (295.90)]
Conditions
Sponsors
Janssen-Cilag International N.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 18 or older; consented;stable schizophrenia (PANSS =17kg/m2;able to perform study requirements 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: psychiatric hospitalization in last 90 days;change in antipsychotic dose in last 45 days;active substance dependence;treatment resistance history;relevant history or currren significant or unstable systemic disease;severe allergy or hypersensitivity to study drug,treatment with disallowed meds
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this study are to evaluate the safety and tolerability of: a). the deltoid muscle injection site for initiating treatment with any of 3 doses of paliperidone palmitate (50, 75, and 100 mg eq.) in subjects with schizophrenia. · b). switching from the gluteal to the deltoid injection site and from the deltoid to the gluteal injection site at therapeutic plasma concentrations with 3 doses of paliperidone palmitate (50, 75, and 100 mg eq.) in subjects with schizophrenia. ;Secondary Objective: The exploration of the pharmacokinetics of paliperidone after intramuscular (i.m.) administration of paliperidone palmitate using the injection site as a covariate and the relationship between its pharmacokinetics and the results of safety parameters of interest. · An evaluation of the incidence of systemic adverse events that occur or worsen during the last 2 injection cycles (8 weeks) of the study. · Assessment of the overall safety and tolerability of paliperidone palmitate ;Primary end point(s): Tolerance of initiation evaluation based on a between group comparison of the incidence of systemic adverse events occurring between the first injection and Week 13 in subjects receiving deltoid injections versus subjects receiving gluteal injections. Tolerance of switching evaluation ased on a within-subject comparison of incidence of systemic adverse events occurring during the last 2 injection intervals (8 weeks) of each treatment period | — |
Countries
Czech Republic, Germany
Outcome results
None listed