Phase 4
Completed N=95
Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Patients With Schizophrenia
Source: ClinicalTrials.gov NCT01724359 ↗Enrolled (actual)
95
Serious AEs
7.4%
Results posted
Mar 2013
Primary outcomePrimary: Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score — 83.99; 53.70 scores on a scale
Summary
The purpose of this study is to evaluate efficacy, safety and tolerability of flexible, once-daily doses of paliperidone extended-release (ER) in patients with schizophrenia from Argentina and Colombia that previously failed treatment with other antipsychotic agents.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score |
83.99; 53.70 | — |
| SECONDARY Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score |
18.53; 11.16 | — |
| SECONDARY Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score |
23.69; 14.64 | — |
| SECONDARY Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score |
41.77; 27.90 | — |
| SECONDARY Clinical Global Impression-Severity (CGIS) |
2; 9; 3; 21; 14; 26 | — |
| SECONDARY Personal and Social Performance (PSP) Scale |
52.06; 68.24 | — |
| SECONDARY Health Status as Measured by Self-rated Health Status Survey SF-36 |
56.39; 67.02 | — |
| SECONDARY Sleep Evaluation Scale |
6.80; 7.66 | — |
| SECONDARY Daytime Drowsiness Evaluation Scale |
4.68; 2.58 | — |
Eligibility Criteria
Inclusion Criteria
- Patient meets the criteria for schizophrenia
- Patient is previously non-acute and has been given an adequate dose of an appropriate oral antipsychotic for an adequate period of time prior to enrollment, but previous treatment is considered unsuccessful due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication
- Patient is healthy on the basis of a physical examination and vital signs at screening
- Women must be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study
Exclusion Criteria
- Patients on clozapine, any conventional depot neuroleptic or risperidone long-acting injections during the last 3 months
- Patients with serious unstable medical condition, including known clinically relevant laboratory abnormalities
- Patients with history or current symptoms of tardive dyskinesia and neuroleptic malignant syndrome
- Patients judged to be at high risk for adverse events, violence, or self-harm
- Patients with known hypersensitivity to paliperidone ER or to risperidone
- Patients with a current use or known history (over the past 6 months) of substance dependence
Data sourced from ClinicalTrials.gov (NCT01724359). 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.