Phase 3
N=201
A Double-blind, Placebo-controlled Study of the Safety and Efficacy of Paliperidone Extended Release (ER) in the Treatment of Schizophrenia in Adolescent Patients
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT00518323 ↗Enrolled (actual)
201
Serious AEs
2.5%
Results posted
Jun 2010
Primary outcome: Primary: Change in the PANSS Total Score From Baseline to the Last Postrandomization Assessment in the Double-blind Period of the Study. — -9.8; -17.3; -13.8; -7.9 units on a scale — p=0.508
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Paliperidone ER (Drug); Placebo (Drug)
- Age
- Pediatric · 12+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the PANSS Total Score From Baseline to the Last Postrandomization Assessment in the Double-blind Period of the Study. |
-9.8; -17.3; -13.8; -7.9 | 0.508 |
| SECONDARY Change From Baseline to End Point in Clinical Global Impression-Severity (CGI-S) Scale |
0.0; -1.0; -1.0; 0.0 | 0.968 |
| SECONDARY Change From Baseline to End Point in Children's Global Assessment (CGAS) Score |
4.4; 13.1; 8.6; 5.0 | 0.846 |
| SECONDARY Change From Baseline to End Point in Sleep Visual Analog Scale (VAS) for Quality of Sleep. |
6.6; 16.0; 14.4; -0.3 | 0.058 |
| SECONDARY Change From Baseline to End Point in Sleep VAS for Daytime Drowsiness |
-6.2; -7.2; 1.0; -2.8 | 0.237 |
Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of 3 weight-based, fixed-dose groups of paliperidone extended release (ER) compared with placebo in adolescent patients between 12 to 17 years of age, who are diagnosed with schizophrenia. Paliperidone ER is an atypical antipsychotic agent approved by the U.S. Food and Drug Administration for the treatment of schizophrenia in adults. Patients may be voluntary inpatients or outpatients at the time of the screening visit, but should have returned to their usual living situation by Day 21 of the double-blind treatment phase. The study duration is approximately 10 weeks. Patients who have completed this study or who were discontinued from this study due to lack of efficacy but have completed at least 21 days of double-blind treatment and are expected to benefit from paliperidone treatment, may enter an optional open-label safety study.
Eligibility Criteria
Inclusion Criteria
- Must meet the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV) criteria for schizophrenia (295.10, 295.20, 295.30, 295.60, 295.90) for 1 year (the diagnosis will be established using the K-SADS-PL, including all supplements)
- Must not be a danger to themselves or others, and must have family support available to be maintained as an outpatient
- Should have had at least 1 adequate treatment with an antipsychotic before participation in this study
- Must have a PANSS score between 60 and 120, inclusive, at screening and baseline
- Weight >=29 kg
Exclusion Criteria
- Meet the DSM-IV criteria at screening for dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, or primary substance induced psychotic disorder. Other comorbid disorders e.g., attention-deficit hyperactivity disorder (ADHD) are allowed as long as the diagnosis of schizophrenia is the primary diagnosis and the comorbid disorders in the investigator's judgment do not require medication
- Mild, moderate, or severe mental retardation (i.e., documented intelligence quotient [IQ] <70) established by previous IQ testing or history
- Women who are pregnant (as confirmed by urine pregnancy test performed at screening or baseline), planning to become pregnant or are nursing
- Have a known or suspected history of seizure disorder, or neuroleptic malignant syndrome, encephalopathic syndrome, tardive dyskinesia, or insulin dependent diabetes mellitus
- Presence of any significant or unstable cardiovascular, respiratory, renal, hepatic, hematologic, endocrine, immunologic, or other systemic disease
Data sourced from ClinicalTrials.gov (NCT00518323). 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.