Phase 3
N=1,117
Safety, Efficacy and Tolerability Study of Paliperidone Extended-Release (ER) in Participants With Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT01662648 ↗Enrolled (actual)
1,117
Serious AEs
5.8%
Results posted
Mar 2014
Primary outcome: Primary: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26 — 85.19; 65.45; -26.60; -20.52 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Paliperidone ER (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Pharmaceutica
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26 |
85.19; 65.45; -26.60; -20.52 | — |
| SECONDARY Percentage of Participants With Greater Than or Equal to 20 Percent (%) Improvement in PANSS Total Score at Week 26 |
72.83; 71.87 | — |
| SECONDARY Change From Baseline in PANSS Total Positive Subscale Score at Week 26 |
21.04; 15.26; -7.17; -5.07 | — |
| SECONDARY Change From Baseline in PANSS Total Negative Subscale Score at Week 26 |
22.73; 16.90; -6.93; -5.32 | — |
| SECONDARY Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 26 |
4.24; 3.29; -1.12; -0.98 | — |
| SECONDARY Change From Baseline in Personal and Social Performance (PSP) Scale at Week 26 |
55.07; 66.03; 13.76; 11.14 | — |
| SECONDARY Change From Baseline in Sleep Quality at Week 26 |
63.53; 67.40; 11.57; 8.19 | — |
| SECONDARY Change From Baseline in Daytime Drowsiness at Week 26 |
32.80; 34.54; -9.52; -11.54 | — |
| SECONDARY Number of Participants Within Each Category of Patient Satisfaction Score |
8; 21; 74; 151; 256; 305 | — |
Summary
The purpose of this study is to explore the 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) who were previously unsuccessfully treated with other oral antipsychotics.
Eligibility Criteria
Inclusion Criteria
- Participant diagnosed with schizophrenia
- Participant's previous treatment of schizophrenia is considered unsuccessful
- Participant is healthy on the basis of a physical examination and vital signs
- Women must be postmenopausal, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study
- Be willing and able to fill out self-administered questionnaires
Exclusion Criteria
- Have used clozapine or Risperdal CONSTA during the last month, or have received any other conventional drug used to treat psychosis during the last 3 months
- Judged to be at high risk for adverse events, violence or self-harm
- Inability to swallow the study medication whole with the aid of water
- Pregnant or breast-feeding female
- History or current symptoms of tardive dyskinesia (involuntary movements of the facial muscles and tongue)
Data sourced from ClinicalTrials.gov (NCT01662648). 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.