Phase 4
Completed N=200
An Efficacy and Safety Study of One Dosage of Paliperidone Extended Release (ER) in Treating Patients With Schizophrenia
Source: ClinicalTrials.gov NCT00524043 ↗Enrolled (actual)
200
Serious AEs
9.5%
Results posted
Feb 2010
Primary outcomePrimary: Change From Baseline in PANSS Total Score at the End of the Double-blind Treatment Phase (Week 6 or the Last Assessment Obtained After the Baseline Assessment). — -11.7; -15.0; -8.9 units on a scale — p=0.504
Summary
The purpose of this study is to assess the efficacy and safety of 1.5 mg/day dose of paliperidone Extended Release (ER) as compared with placebo when used to treat patients with schizophrenia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in PANSS Total Score at the End of the Double-blind Treatment Phase (Week 6 or the Last Assessment Obtained After the Baseline Assessment). |
-11.7; -15.0; -8.9 | 0.504 |
| SECONDARY Change From Baseline to the End of the Double-blind Treatment Phase (Week 6 or the Last Assessment Obtained After the Baseline Assessment) in CGI-S |
-1.0; -0.5; 0.0 | 0.626 |
| SECONDARY Change From Baseline to End Point (Week 6 or the Last Assessment After the Baseline Assessment) in PSP Score |
1.6; 5.7; 2.9 | 0.870 |
| SECONDARY Change From Baseline to End Point (Week 6 or the Last Assessment After the Baseline Assessment) in MOS SF-36 Physical Component Summary Scale Score |
0.4; 0.6; -0.2 | 0.126 |
| SECONDARY Change From Baseline to End Point (Week 6 or the Last Assessment After the Baseline Assessment) in MOS SF-36 Mental Component Summary Scale Score |
3.5; 6.1; 2.1 | 0.691 |
Eligibility Criteria
Inclusion Criteria
- Diagnosed with schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) (295.10, 295.20, 295.30, 295.60, 295.90) at least 1 year before screening
- Experiencing an acute episode with a total PANSS score at screening of between 70 and 120
- Are otherwise physically healthy
- Agree to at least 8 days of voluntary hospitalization.
Exclusion Criteria
- Active comorbid DSM-IV axis I diagnosis other than schizophrenia (nicotine and caffeine dependence are not exclusionary)
- Treatment with antidepressants (unless a subject has been on a stable dosage for at least 3 months before baseline) other than monoamine oxidase inhibitors
- DSM-IV diagnosis of substance dependence within 6 months before screening evaluation (nicotine and caffeine dependence are not exclusionary)
- Any medical condition that could potentially alter the absorption, metabolism, or excretion of the study medication, such as Crohn's disease, liver disease, or renal disease
- Relevant history of any significant or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular), renal, hepatic, endocrine, or immunologic disease.
Data sourced from ClinicalTrials.gov (NCT00524043). 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. Informational only — not medical advice.