Schizophrenia
Conditions
Keywords
paliperidone, Schizophrenia
Brief summary
The purpose of the study was an Open Label Extension to the recurrence prevention study to evaluate long-term safety and tolerability of paliperidone ER in subjects with schizophrenia.
Detailed description
The primary objective of the open-label extension was the long-term assessment of safety and tolerability of ER OROS paliperidone 3 to 15 mg/day in subjects diagnosed with schizophrenia. In addition, the long-term efficacy and effect of ER OROS paliperidone on overall functioning and personal and social functioning, as well as quality of life, health economics, and subjective sleep measures, was explored. This open-label extension study followed a recurrence prevention study (R076477-SCH-301) that had both an open-label run-in/stabilization phase and a double-blind, placebo-controlled phase. Open-label study drug (ER OROS paliperidone 3 mg to 15 mg/day) was administered for 52 weeks.
Interventions
Sponsors
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects who had experienced a recurrence event during the double blind phase of Study R076477-SCH-301 * Remained recurrence free until the end of the double-blind phase, or were in the run-in or stabilization phases when the study was terminated * Who signed the informed consent for the open-label extension * And who the investigator agreed that open-label treatment was in the best interest of the subject were eligible to participate in the open-label extension
Exclusion criteria
* Not eligible to enter the open-label phase if believed to be at significant risk for suicidal or violent behavior during the open-label extension trial * Were pregnant or had received an injection of a depot antipsychotic since entry into the preceding double-blind phase
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Long-term assessment of safety and tolerability of ER OROS paliperidone 3 to 15 mg/day in subjects diagnosed with schizophrenia | — |
Secondary
| Measure | Time frame |
|---|---|
| Long-term efficacy and effect of ER OROS paliperidone on overall functioning and personal and social functioning, quality of life, health economics, and subjective sleep measures | — |
Outcome results
None listed