Phase 3
N=452
A Comparative Study of Paliperidone Palmitate and Risperidone Long Acting Injection (LAI) in Participants With Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT00604279 ↗Enrolled (actual)
452
Serious AEs
2.4%
Results posted
Jul 2013
Primary outcome: Primary: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 92 or Early Withdrawal — 82.1; 84.4; -23.6; -26.9 Units on scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Paliperidone palmitate (R092670) (Drug); Risperidone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Xian-Janssen Pharmaceutical Ltd.
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 92 or Early Withdrawal |
82.1; 84.4; -23.6; -26.9 | — |
| SECONDARY Change From Baseline in Personal and Social Performance (PSP) Score at Day 92 or Early Withdrawal |
47.8; 45.3; 16.8; 18.6 | — |
| SECONDARY Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Day 92 or Early Withdrawal |
4.9; 5.0; -1.5; -1.7 | — |
| SECONDARY Change From Baseline in the Sleep Visual Analog Scale (VAS) Score at Day 92 or Early Withdrawal |
64.1; 66.6; 8.2; 10.0; 29.9; 29.6 | — |
| SECONDARY Percentage of Participants Who Responded to PANSS Total Score at Day 92 or Early Withdrawal |
70.7; 78.4 | — |
Summary
The purpose of this study is to compare the efficacy of paliperidone palmitate and risperidone long acting injection (LAI) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) along with safety and tolerability.
Eligibility Criteria
Inclusion Criteria
- Participants who meet diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (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 and prior medical records, written documentation, or verbal information obtained from previous psychiatric providers obtained by the investigator must be consistent with the diagnosis of schizophrenia
- A total Positive and Negative Syndrome Scale (PANSS) score between 60 and 120, inclusive, at screening and baseline
- Body mass index (BMI) of equal to or greater than 17.0 kilogram per meter square (kg/m^2)
- Female participants must be postmenopausal for at least 2 years, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before study entry and throughout the study
- Be capable of self-administering study medication (applies to oral supplementation) or have assistance with study medication administration consistently available throughout the first 4 weeks of the study Exclusion Criteria:
- A primary, active DSM-IV diagnosis on Axis I other than schizophrenia
- A decrease of at least 25 percent in the total PANSS score between screening and baseline
- Participants who have previously participated in this study
- A DSM-IV diagnosis of active substance dependence within 3 months before screening (nicotine and caffeine are not exclusionary)
- History of treatment resistance as defined by failure to respond to 2 adequate treatments with different antipsychotic medications (an adequate treatment is defined as a minimum of 6 weeks at maximum tolerated dosage)
Data sourced from ClinicalTrials.gov (NCT00604279). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.