Phase 4
Completed N=223
A Study to Evaluate Participants Satisfaction, Quality of Life and Effectiveness of Flexible-Dose of Paliperidone Extended Release (ER) in Participants With Schizophrenia, Previously Treated With Risperidone
Source: ClinicalTrials.gov NCT01010776 ↗Enrolled (actual)
223
Serious AEs
4.6%
Results posted
Nov 2013
Primary outcomePrimary: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26 - Main Phase — -22.9 Units on a scale
Summary
The purpose of this study is to evaluate effectiveness, tolerability (how well a participant can stand a particular medicine or treatment), and safety of flexible-dose of 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 taking risperidone (an antipsychotic), but who are not satisfied with their treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26 - Main Phase |
-22.9 | — |
| PRIMARY Change From Baseline in PANSS Total Score at Week 52 - Main Phase Plus Extension Phase |
93.25; -26.4 | — |
| SECONDARY Percentage of Participants With Treatment Response in PANSS Total Score - Main Phase |
60.1 | — |
| SECONDARY Percentage of Participants With Treatment Response in PANSS Total Score - Main Phase Plus Extension Phase |
71.1 | — |
| SECONDARY Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13 and 26 - Main Phase |
-3.6; -3.6; -5.0; -5.0; -5.9; -5.9 | — |
| SECONDARY Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase |
26.65; 19.25; -3.4; -3.4; -5.4; -5.4 | — |
| SECONDARY Change From Baseline in Personal and Social Performance (PSP) Scale Score at Week 4, 8, 13 and 26 - Main Phase |
5.7; 8.3; 9.9; 10.4 | — |
| SECONDARY Change From Baseline in PSP Scale Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase |
45.17; 5.3; 9.0; 9.7; 12.0; 12.6 | — |
| SECONDARY Change From Baseline in Pittsburg Sleep Quality Index (PSQI) Score at Week 4, 8, 13 and 26 - Main Phase |
6.7; -1.0; -1.2; -1.5; -1.4 | — |
| SECONDARY Change From Baseline PSQI Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase |
6.4; -1.0; -1.3; -1.5; -1.4; -1.9 | — |
| SECONDARY Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase |
2; 4; 52; 114; 40; 1 | — |
| SECONDARY Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Extension Phase |
2; 22; 41; 55; 22; 10 | — |
| SECONDARY Percentage of Participants With Treatment Satisfaction - Main Phase |
11.7; 38.5; 34.3; 12.7; 2.8; 29.5 | — |
| SECONDARY Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase |
13.2; 40.9; 32.1; 11.3; 2.5; 31.4 | — |
| SECONDARY 36-Item Short-Form Health Survey (SF-36) Score - Main Phase |
47.9; 35.9; 48.4; 38.3 | — |
| SECONDARY 36-Item Short-Form Health Survey (SF-36) Score - Main Phase Plus Extension Phase |
48.7; 35.7; 48.8; 38.5 | — |
Eligibility Criteria
Inclusion Criteria
- Female participants must be postmenopausal (after the time in life when a woman stops having a menstrual period) or surgically sterile or if sexually active, practicing an effective method of birth control (e.g., oral contraceptive, intrauterine device [IUD - an intrauterine device made of plastic and/or copper that is inserted into the womb [uterus] by way of the vaginal canal to used to prevent pregnancy], diaphragm with spermicide [agent that kills spermatozoa] or condom [cover worn over the penis during sexual intercourse to prevent infection or pregnancy] with spermicide) throughout the study and have a negative serum beta - Human Chorionic Gonadotropin (HCG) pregnancy test at screening
- Participants on oral monotherapy (treatment with a single drug) with risperidone in a regimen within the daily dosage recommended by the package insert and adhering to the prescribed risperidone regimen for at least 30 days before entering the study
- Participants with partial response to the current risperidone regimen (persistent symptoms or unstable clinical condition) or presence of unbearable side effects
- Potential Participants switching to another atypical antipsychotic due to their clinical response and/or side effects profile.
Exclusion Criteria
- Participants with past or current history of psychiatric disease other than schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV
- Participants with concomitant (given at the same time) severe (very serious, life threatening) medical or neurological disorder or risk of suicide
- Participants previously using clozapine
- Participants with a history of previous non-responsiveness to oral antipsychotic treatment
- Pregnant or breast-feeding female participants
Data sourced from ClinicalTrials.gov (NCT01010776). 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. Informational only — not medical advice.