Phase 3
N=201
An Efficacy Study of Paliperidone for the Prevention of Relapse in Participants With Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT01662310 ↗Enrolled (actual)
201
Serious AEs
3.2%
Results posted
Jun 2014
Primary outcome: Primary: Double Blind (DB) Phase: Median Time to Relapse — NA; 49.0 Days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Paliperidone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Research & Development, LLC
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Double Blind (DB) Phase: Median Time to Relapse |
NA; 49.0 | — |
| SECONDARY Run-In and Stabilization Phase: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 14 |
89.5; -30.8 | — |
| SECONDARY Double Blind (DB) Phase: Change From DB Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at DB Endpoint |
53.4; 51.5; 2.0; 16.9 | — |
| SECONDARY Run-In and Stabilization Phase: Number of Participants Assessed With Categorical Scores Based on Clinical Global Impression-Severity Scale (CGI-S) |
0; 2; 0; 37; 3; 65 | — |
| SECONDARY Double Blind (DB) Phase: Change From DB Baseline in Clinical Global Impression-Severity Scale (CGI-S) Total Score at DB Endpoint |
3.0; 2.9; 0.1; 1.1 | — |
| SECONDARY Run-In and Stabilization Phase: Change From Baseline in Personal and Social Performance (PSP) Scale Total Score at Week 14 |
43.6; 20.9 | — |
| SECONDARY Double Blind (DB) Phase: Change From DB Baseline in Personal and Social Performance (PSP) Scale Total Score at DB Endpoint |
69.3; 69.9; -2.9; -10.7 | — |
| SECONDARY Run-In and Stabilization Phase: Change From Baseline in Sleep Quality Based on Visual Analog Scale (VAS) at Week 14 |
63.4; 12.1 | — |
| SECONDARY Double Blind (DB) Phase: Change From DB Baseline in Sleep Quality Based on Visual Analog Scale (VAS) at DB Endpoint |
77.5; 81.9; -3.8; -22.4 | — |
| SECONDARY Run-In and Stabilization Phase: Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale (VAS) at Week 14 |
32.8; -7.3 | — |
| SECONDARY Double Blind (DB) Phase: Change From DB Baseline in Daytime Drowsiness Based on Visual Analog Scale (VAS) at DB Endpoint |
22.9; 24.4; 3.1; 1.2 | — |
| SECONDARY Double Blind (DB) Phase: Median Time to Relapse (Final Analysis) |
NA; 52.0 | — |
| SECONDARY Open-label Extension (OLE) Phase: Change From OLE Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at OLE Endpoint |
56.5; 67.2; -3.9; -15.4 | — |
| SECONDARY Open-label Extension (OLE) Phase: Change From OLE Baseline in Clinical Global Impression-Severity Scale (CGI-S) Total Score at OLE Endpoint |
3.1; 3.9; -0.2; -0.9 | — |
| SECONDARY Open-label Extension (OLE) Phase: Change From OLE Baseline in Personal and Social Performance (PSP) Scale Total Score at OLE Endpoint |
66.8; 60.6; 10.88; 10.7 | — |
Summary
The purpose of this study is to evaluate the efficacy, tolerability and safety of paliperidone extended release (ER) tablets (between 3 to 12 milligram (mg), once a day) in the prevention of relapse in schizophrenia participants.
Eligibility Criteria
Inclusion Criteria
- Have a diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV)
- Have experienced an acute episode, with a Positive and Negative Syndrome Scale (PANSS) total score between 70 and 120 inclusive, at Screening and Baseline
- Women must be postmenopausal (for at least 1 year), surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), practicing a highly effective method of birth control, if sexually active
- Men must be using a highly effective method of birth control and must not donate sperm during the study and for 3 months after receiving the last dose of study drug
- Be willing and capable to complete the questionnaires and able to take oral medications independently
Exclusion Criteria
- Has drug dependence diagnosis according to DSM-IV (excluding nicotine and caffeine dependence) within 6 months before screening
- Participants with Crohn's disease and hepatic or renal diseases
- Has had relevant history of any significant and/or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular dysfunction), renal, hepatic, endocrine, or immunologic diseases
- Has had history of neuroleptic malignant syndrome (the disorder caused by antipsychotic drugs with symptoms of fever, muscle rigidity and delirium)
- Has had known or suspected Stevens Johnson Syndrome (an immune disease with symptoms of fever, sore throat, ulcers and conjunctivitis) after exposure to phenytoin, carbamazepine, barbiturates, or lamotrigine
- Had been treated with clozapine for treatment refractory or treatment resistant schizophrenia
- Has significant risk of suicide or homicidal behavior, or significant risk of deliberate self harm or harm to others
- Has taken isocarboxazid, phenelzine, selegiline and tranylcypromine within 4 weeks before screening
- Has received electroconvulsive therapy within 60 days before screening
Data sourced from ClinicalTrials.gov (NCT01662310). 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.