Phase 4
N=299
An Efficacy, Safety And Tolerability Study of Flexibly Dosed Paliperidone Extended-Release (ER) in Participants With Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT00757705 ↗Enrolled (actual)
299
Serious AEs
3.7%
Results posted
Feb 2014
Primary outcome: Primary: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 24 — 72.4; -6.9 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Paliperidone ER (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Taiwan Ltd
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 24 |
72.4; -6.9 | — |
| SECONDARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 24 |
21.6; -2.2; 17.0; -1.7; 16.7; -1.4 | — |
| SECONDARY Percentage of Participants With at Least 20 Percent Improvement in Positive and Negative Syndrome Scale (PANSS) Total Score |
31.3 | — |
| SECONDARY Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24 |
54.5; 3.4 | — |
| SECONDARY Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 24 |
48.9; 5.8 | — |
| SECONDARY Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 24 |
4.3; -0.5 | — |
| SECONDARY Change From Baseline in Short-Form 36 Health Survey (SF-36) Score at Week 24 |
61.3; 0.6; 53.1; 2.0 | — |
| SECONDARY Number of Participants With Satisfaction With the Study Treatment |
11; 83; 83; 49; 11 | — |
| SECONDARY Change From Baseline in Sleep Quality and Daytime Drowsiness Score at Week 24 |
3.2; 0.1; 2.6; -0.3 | — |
Summary
The purpose of the study is to explore the maintained efficacy, tolerability, and safety 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) previously unsuccessfully treated with other oral atypical antipsychotic medication.
Eligibility Criteria
Inclusion Criteria
- Participant meets the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for schizophrenia
- Participant has been given an adequate dose of an appropriate oral atypical antipsychotic for an adequate period of time prior to enrollment, but previous treatment is considered unsuccessful due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication
- Participant or their legally acceptable representatives must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
- Female participants must be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study and must also have a negative urine pregnancy test at screening
- Male or female, aged greater than or equal to 18 years
Exclusion Criteria
- Participants on clozapine, any conventional depot neuroleptic or Risperdal CONSTA during the last 3 months
- Participants with serious unstable medical condition, including known clinically relevant laboratory abnormalities
- Participants with history or current symptoms of tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body)
- Participants with history of neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness)
- Participants with a current use or known history (over the past 6 months) of substance dependence except for nicotine, caffeine, and betal nut according to DSM-IV Criteria
Data sourced from ClinicalTrials.gov (NCT00757705). 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.