Phase 4
N=491
PaliperidoNe Extended-Release [ER] Dosing and Clinical Response in Acute Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT00761189 ↗Enrolled (actual)
491
Serious AEs
11.2%
Results posted
Mar 2014
Primary outcome: Primary: Percentage of Participants Assessed as Very Much Improved or Much Improved Based on Clinical Global Impression-Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population — 34.78 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Paliperidone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Korea, Ltd., Korea
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Assessed as Very Much Improved or Much Improved Based on Clinical Global Impression-Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population |
34.78 | — |
| PRIMARY Percentage of Participants Assessed as Very Much Improved or Much Improved Based on Clinical Global Impression-Improvement (CGI-I) Scale - Per Protocol (PP) Population |
41.92 | — |
| SECONDARY Personal and Social Performance (PSP) Scale Score - Intent-to-treat (ITT) Population |
49.39; 59.44; 62.76 | — |
| SECONDARY Personal and Social Performance (PSP) Scale Score - Per Protocol (PP) Population |
49.70; 60.27; 64.73 | — |
| SECONDARY Percentage of Participants Continuously Treated With 6 Milligram Per Day Regimen Until Week 12 - Intent-to-treat (ITT) Population |
38.84 | — |
| SECONDARY Percentage of Participants Continuously Treated With 6 Milligram Per Day Regimen Until Week 12 - Per Protocol (PP) Population |
41.54 | — |
| SECONDARY Drug Attitude Inventory (DAI) Score - Intent-to-treat (ITT) Population |
-2.34; -3.37; -3.57 | — |
| SECONDARY Drug Attitude Inventory (DAI) Score - Per Protocol (PP) Population |
-2.39; -3.49; -4.02 | — |
| SECONDARY Clinical Global Impression - Severity (CGI-S) Score - Intent-to-treat (ITT) Population |
4.62; 4.08; 3.73; 3.50; 3.29 | — |
| SECONDARY Clinical Global Impression - Severity (CGI-S) Score - Per Protocol (PP) Population |
4.60; 4.02; 3.66; 3.40; 3.10 | — |
| SECONDARY Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population |
5; 115; 158; 46; 15; 6 | — |
| SECONDARY Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Per Protocol (PP) Population |
5; 104; 118; 28; 5; 0 | — |
Summary
The purpose of this study is to evaluate the efficacy of paliperidone extended-release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).
Eligibility Criteria
Inclusion Criteria
- Participants with Clinical Global Impression-Severity (CGI-S) score greater than or equal to 4 points (moderately ill) at Screening
- Childbearing potential women who consent to the consistent use of the acceptable contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)
- Participants who are capable of and willing to fill out the questionnaire for themselves
- Participants who are compliant with self-medication or can receive consistent help or support
- Have schizophrenia diagnosis by Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)
Exclusion Criteria
- Participants with the past history of neuroleptic malignant syndrome (NMS)
- Participants with Treatment Resistance history who have failed to be properly treated with more than two other kinds of antipsychotic agents (at least 4 weeks of the therapeutic dose administration)
- Participants with severe (pathologic or iatrogenic) gastrointestinal stenosis or participants who can not swallow the drug whole (The study drug must not be chewed, divided, melted or grinded because it can impact the study drug release profile.)
- Participants who have been exposed to the study drug within one month before screening
- Participants with significant risk including suicide or aggressive behavior
Data sourced from ClinicalTrials.gov (NCT00761189). 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.