| Title |
Safety and efficacy of paliperidone extended-release in Chinese patients with schizophrenia: a 24-week, open-label extension of a randomized, double-blind, placebo-controlled study
|
|---|---|
| Published in |
Neuropsychiatric Disease and Treatment, January 2016
|
| DOI | 10.2147/ndt.s88875 |
| Pubmed ID | |
| Authors |
Hongyan Zhang, Huafang Li, Yanning Liu, Cathy Wu, Qingqi Wu, Isaac Nuamah, Jianguo Shi, Shiping Xie, Gang Wang, Srihari Gopal |
| Abstract |
The long-term safety, tolerability, and efficacy of paliperidone extended-release (ER) were evaluated in Chinese patients with schizophrenia. Patients (aged ≥18 years) with schizophrenia (Diagnostic and Statistical Manual of Mental Disorders, 4th edition criteria) who had completed run-in (8-week), stabilization (6-week), and double-blind (DB) phases (variable) of a phase-3, placebo-controlled study entered this 24-week, open-label extension (OLE) study. These patients, who had either experienced a relapse or remained relapse-free through DB phase of the study, were treated with flexible-dose paliperidone-ER (3-12 mg/day) during the OLE phase. Major safety evaluations included treatment-emergent adverse events (TEAEs) and extrapyramidal symptoms. Efficacy endpoints included changes in Positive and Negative Syndrome Scale total score, Clinical Global Impression-Severity scale, and Personal and Social Performance scale from OLE baseline to OLE endpoint. Out of 106 patients who entered the OLE phase (placebo: 59, paliperidone-ER: 47), a total of 85 (80%) completed it. Thirty-five (33%) patients experienced at least one TEAE; most common were akathisia, somnolence, nasopharyngitis, and constipation (3.8% each). Serious TEAEs were noted in two patients (completed suicide; schizophrenia worsening). No TEAEs with an onset during the OLE phase led to discontinuation. Extrapyramidal symptoms related-TEAEs were reported in eight (7.5%) patients. Mean (standard deviation) changes in Positive and Negative Syndrome Scale total scores (-10.4 [13.2]), Clinical Global Impression-Severity scores (-0.6 [0.96]) and Personal and Social Performance scores (7.4 [13.2]) from OLE baseline to OLE endpoint showed patients who had been treated with placebo during the DB phase experienced more pronounced improvements. In this OLE study, flexibly dosed paliperidone-ER (3-12 mg/day) was tolerable and efficacious in Chinese patients with schizophrenia. |
X Demographics
The data shown below were collected from the profiles of 3 X users who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 3 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Practitioners (doctors, other healthcare professionals) | 2 | 67% |
| Members of the public | 1 | 33% |
Mendeley readers
The data shown below were compiled from readership statistics for 47 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 47 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Master | 7 | 15% |
| Student > Bachelor | 7 | 15% |
| Researcher | 5 | 11% |
| Student > Ph. D. Student | 5 | 11% |
| Professor > Associate Professor | 4 | 9% |
| Other | 11 | 23% |
| Unknown | 8 | 17% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 17 | 36% |
| Psychology | 6 | 13% |
| Pharmacology, Toxicology and Pharmaceutical Science | 3 | 6% |
| Nursing and Health Professions | 2 | 4% |
| Chemistry | 2 | 4% |
| Other | 5 | 11% |
| Unknown | 12 | 26% |
Attention Score in Context
This research output has an Altmetric Attention Score of 2. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 27 January 2016.
All research outputs
#15,740,207
of 25,374,647 outputs
Outputs from Neuropsychiatric Disease and Treatment
#1,506
of 3,132 outputs
Outputs of similar age
#212,126
of 399,679 outputs
Outputs of similar age from Neuropsychiatric Disease and Treatment
#49
of 70 outputs
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