Phase 3
Completed N=188
A Trial to Explore the Tolerability, Safety and Efficacy of Paliperidone Extended Release in Patients With Schizophrenia
Source: ClinicalTrials.gov NCT01606228 ↗Enrolled (actual)
188
Serious AEs
2.1%
Results posted
Oct 2012
Primary outcomePrimary: The Proportion of Patients Improving 20% in Total Positive and Negative Syndrome Scale (PANSS) at Endpoint (Day 90) — 97.73 percentage of patients
Summary
The purpose of this study is to explore the tolerability, safety and efficacy of flexibly dosed paliperidone extended release (ER) among patients with schizophrenia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion of Patients Improving 20% in Total Positive and Negative Syndrome Scale (PANSS) at Endpoint (Day 90) |
97.73 | — |
| SECONDARY Positive and Negative Syndrome Scale (PANSS) Scores at Baseline |
108.25 | — |
| SECONDARY Positive and Negative Syndrome Scale (PANSS) Scores at Day 90 |
48.74 | — |
| SECONDARY Clinical Global Impression-Severity (CGIS) Scores at Baseline |
0; 0; 0; 11; 33; 14 | — |
| SECONDARY Clinical Global Impression-Severity (CGIS) Scores at Day 90 |
0; 31; 20; 8; 1; 0 | — |
| SECONDARY Personal and Social Performance (PSP) Scores at Baseline |
37.23 | — |
| SECONDARY Personal and Social Performance (PSP) Scores at Day 90 |
75.66 | — |
| SECONDARY Patient Satisfaction With Paliperidone Treatment |
33; 34; 4; 1; 1 | — |
| SECONDARY Quality of Sleep at Baseline |
33.99 | — |
| SECONDARY Quality of Sleep at Day 90 |
86.56 | — |
| SECONDARY Daytime Drowsiness at Baseline |
21.49 | — |
| SECONDARY Daytime Drowsiness at Day 90 |
11.23 | — |
Eligibility Criteria
Inclusion Criteria
- Patients diagnosed with schizophrenia
- Patient with Positive and Negative Syndrome Scale (PANSS) score of 80 to 120 at screening
- Patients who have not taken any antipsychotics in the past, and those were newly diagnosed with schizophrenia who have not taken any antipsychotics for at least one month prior to screening
- Patient healthy on the basis of a physical examination, laboratory examination, and vital signs
- Women must have a negative pregnancy test, and agree to practice an effective method of birth control before entry and throughout the study
Exclusion Criteria
- Serious unstable medical condition, including known clinically relevant laboratory abnormalities
- 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 (patients may not chew, divide, dissolve, or crush the study medication)
- Biochemistry results that are out of the laboratory's normal reference range and are deemed to be clinically significant by the investigator
- Patients with a current use or known history (over the past 6 months) of substance dependence
- Positive urine drug examination
Data sourced from ClinicalTrials.gov (NCT01606228). 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.