Evidence map›Paper›PMID 28814873›Full record

ArticleNeuropsychiatric disease and treatment2017

Safety and efficacy of paliperidone palmitate 1-month formulation in Chinese patients with schizophrenia: a 25-week, open-label, multicenter, Phase IV study.

Jingping Zhao, Lehua Li, Jianguo Shi, Yi Li, Xiufeng Xu, Keqing Li, Lili Zhang, Shangli Cai, Yu Feng, Jianmin Zhuo and 2 more

Abstract read
In one paragraph

Article in Neuropsychiatric disease and treatment, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  6. Risk of Drug-induced Movement Disorders with Newer Antipsychotic Agents.Tremor and other hyperkinetic movements (New York, N.Y.) · 2022
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Jingping ZhaoDepartment of Psychiatry, The Mental Health Institute, The Second Xiangya Hospital of Central South University.
Lehua LiDepartment of Psychiatry, The Mental Health Institute, The Second Xiangya Hospital of Central South University.
Jianguo ShiDepartment of Psychiatry, Mental Health Center of Xi'an City.
Yi LiDepartment of Psychiatry, Mental Health Center of Wuhan City.
Xiufeng XuDepartment of Psychiatry, First Affiliated Hospital of Kunming Medical University.
Keqing LiDepartment of Psychiatry, The Sixth People's Hospital of Hebei Province.
Lili ZhangDepartment of Medical Affairs, Xi'an Janssen Pharmaceutical Ltd., Beijing, People's Republic of China.
Shangli CaiDepartment of Medical Affairs, Xi'an Janssen Pharmaceutical Ltd., Beijing, People's Republic of China.
Yu FengDepartment of Medical Affairs, Xi'an Janssen Pharmaceutical Ltd., Beijing, People's Republic of China.
Jianmin ZhuoDepartment of Medical Affairs, Xi'an Janssen Pharmaceutical Ltd., Beijing, People's Republic of China.
Weihong LiuDepartment of Medical Affairs, Xi'an Janssen Pharmaceutical Ltd., Beijing, People's Republic of China.
Huafei LuDepartment of Medical Affairs, Xi'an Janssen Pharmaceutical Ltd., Beijing, People's Republic of China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

rationaleLong-acting injectable (LAI) paliperidone palmitate 1-month formulation (PP1M) has demonstrated acceptable tolerability and favorable clinical outcomes in Western and Asian patients with schizophrenia. Hence, analysis of the outcomes of long-term PP1M treatment specifically in Chinese patients is of interest.

objectiveThe aim of this study is to evaluate the long-term safety and efficacy of PP1M treatment in Chinese patients with schizophrenia.

methodsIn this 25-week, open-label, Phase IV study, patients (18-65 years) diagnosed with schizophrenia and having a baseline Positive and Negative Syndrome Scale (PANSS) total score of 60-120 (inclusive) were enrolled. All patients received injections of PP1M 150 mg eq. (day 1) and 100 mg eq. (day 8), followed by a flexible once-monthly maintenance dosing (75, 100, or 150 mg eq.).

resultsOf the 353 patients, 234 (66.3%) completed the study treatment (mean age, 31.1 years; 52.7% men). The PANSS total score (primary end point) improved significantly over the 6-month treatment period (mean [standard deviation] change from baseline to end of treatment, -27.2 [18.30];

conclusionLong-term treatment with PP1M was efficacious, and no new safety concerns were identified in Chinese patients with schizophrenia. Overall, the results were comparable with observations from previous studies.

Indexed as

Chineselong-acting injectablesopen-labelpaliperidone palmitatePANSSschizophrenia

Identifiers

PMID28814873
PMCPMC5546821

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.