Phase 4
N=190
Paliperidone Extended Release(ER) Effectiveness Study to Evaluate the Objective Symptom Change and Symptomatic Remission
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT00761579 ↗Enrolled (actual)
190
Serious AEs
12.1%
Results posted
Jun 2014
Primary outcome: Primary: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48 — 11.57; 6.43; 16.36 Units on a scale
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
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48 |
11.57; 6.43; 16.36 | — |
| PRIMARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score at Week 48 |
3.53; 1.05; 5.00 | — |
| PRIMARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score at Week 48 |
2.53; 2.19; 3.36 | — |
| PRIMARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score at Week 48 |
5.51; 3.19; 8.00 | — |
| SECONDARY Change From Baseline in Personal and Social Performance Scale (PSP) Score at Week 48 |
-6.73; -2.38; -11.36 | — |
| SECONDARY Change From Baseline in Drug Attitude Inventory (DAI-10) at Week 48 |
-0.01; -0.95; 0.08 | — |
| SECONDARY Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale Score at Week 48 |
-1.17; -5.05; 2.40 | — |
| SECONDARY Change From Baseline in Daytime Drowsiness at Week 48 |
5.40; 2.10; 11.40 | — |
| SECONDARY Change From Baseline in Sleep Quality at Week 48 |
1.50; -7.76; 3.40 | — |
| SECONDARY Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 48 |
14.88; 12.38; 25.44 | — |
Summary
The purpose of this study is to investigate the safety and efficacy of flexibly dosed 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
- Childbearing potential women who consent to the use of the consistently permissible contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)
- Participants who are compliant with self-medication or can receive consistent help or support
- Participants who need to change the antipsychotic drug to another one for the following reasons among the participants treated with an antipsychotic drug for more than two weeks before the screening (1) Group of lack of efficacy: the antipsychotic drug is clinically required to be changed because there is no or little therapeutic response despite the appropriately dosed antipsychotic therapy (2) Group of lack of tolerance: the antipsychotic drug is required to be changed due to lack of tolerance to the existing antipsychotic drug or the safety issue (3) Group of lack of compliance: the antipsychotic drug is required to be changed due to lack of medication compliance or the participant wants to change the antipsychotic drug)
- 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 who are suspicious of having clinically significant risk including suicide or aggressive behavior and are expected to unable to complete the study(based on the investigator's judgment)
- Participants with severe preexisting gastrointestinal narrowing (pathologic or iatrogenic) or participants who cannot 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 with significant abnormal findings in blood chemistry, hematological and urine analyses which are clinically significant at the investigator's discretion
- Female Participants who are pregnant or are breast feeding
Data sourced from ClinicalTrials.gov (NCT00761579). 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.