Phase 4
N=133
Paliperidone Extended Release in Schizophrenia Participants With Duration of Illness Less Than 10 Years
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT01362439 ↗Enrolled (actual)
133
Serious AEs
0.8%
Results posted
Jun 2013
Primary outcome: Primary: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 13 — 88.98; 22.468 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Paliperidone ER (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen-Cilag S.p.A.
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 13 |
88.98; 22.468 | — |
| SECONDARY Change in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score at Week 13 |
21.03; -6.55 | — |
| SECONDARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score at Week 13 |
23.11; -4.82 | — |
| SECONDARY Change in Positive and Negative Syndrome Scale (PANSS) General Psychopathology Subscale Score at Week 13 |
44.84; -11.31 | — |
| SECONDARY Percentage of Participants With Greater Than or Equal to 30 Percent Treatment Response in Total Positive and Negative Syndrome Scale (PANSS) Score |
40.5 | — |
| SECONDARY Change From Baseline in Subjective Well-being Under Neuroleptic (SWN 20) Scale at Week 13 |
73.81; 6.86 | — |
| SECONDARY Change From Baseline in Drug Attitude Inventory (DAI 30) Scale at Week 13 |
41.20; 2.0 | — |
| SECONDARY Clinical Global Impression-Severity Scale (CGI-S) |
4; 3 | — |
| SECONDARY Change From Baseline in Personal and Social Performance Scale (PSP) at Week 13 |
56.54; 9.05 | — |
| SECONDARY Quality of Sleep Score |
6.22; 7.08 | — |
| SECONDARY Daytime Drowsiness Evaluation Scale |
4.09; 3.30 | — |
| SECONDARY Extrapyramidal Symptoms Scale (ESRS) Subscale Scores and Total Scores |
7.39; 2.21; 1.86; 0.56; 4.30; 1.33 | — |
Summary
The purpose of this study is to evaluate the effectiveness and safety of paliperidone extended release (ER) in symptomatic participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) who were receiving treatment with any oral (having to do with the mouth) antipsychotic medication and who needed to be switched to paliperidone ER from the current oral antipsychotic therapy due to insufficient efficacy or due to side effects.
Eligibility Criteria
Inclusion Criteria
- Participants meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self)
- Positive and Negative Syndrome Scale (PANSS) total score at Baseline of greater than equal to 70 and less than equal to 100
- Participants who need to be switched from the current oral antipsychotic therapy because of lack of efficacy or side effects
- Participants followed as outpatients
- Female participants must be postmenopausal for at least 1 year, surgically sterile or, if sexually active, be practicing an effective method of birth control and female participants of childbearing potential must also have a negative urine pregnancy test at Baseline
Exclusion Criteria
- Acute psychotic relapse that requires hospitalization and first antipsychotic treatment ever
- Participants who had received clozapine during the previous 3 months
- 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) and neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness)
- Pregnant or breast-feeding female
- Participated in an investigational drug trial in the previous 30 days
Data sourced from ClinicalTrials.gov (NCT01362439). 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.