Evidence map›Paper›PMID 37232002›Full record

Trial reportNeuropsychopharmacology reports2023

Long-term safety and efficacy of sublingual asenapine for the treatment of schizophrenia: A phase III extension study with follow-up for 52 weeks (P06125)-Secondary publication.

Toshihiko Kinoshita, Yoshiteru Takekita, Shuichi Hiraoka, Fumihiro Tamura, Yasuhiro Iwama

Open access · goldAbstract readClinical Trial, Phase III
In one paragraph

Trial report in Neuropsychopharmacology reports, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.8field-weighted citation impact, top 16% of its field
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

5 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
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  5. Article
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

5 authors at 2 institutions in 1 country.

Toshihiko KinoshitaDepartment of Neuropsychiatry, Kansai Medical University, Osaka, Japan.ORCID 0000-0001-9901-9753
Yoshiteru TakekitaDepartment of Neuropsychiatry, Kansai Medical University, Osaka, Japan.
Shuichi HiraokaMeiji Seika Pharma Co., Ltd., Tokyo, Japan.
Fumihiro TamuraMeiji Seika Pharma Co., Ltd., Tokyo, Japan.
Yasuhiro IwamaMeiji Seika Pharma Co., Ltd., Tokyo, Japan.
Unitika (Japan) · JPKansai Medical University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

After completion of a 6-week double-blind trial of asenapine sublingual tablets (10 or 20 mg/day) versus placebo in Asian patients with acute exacerbation of schizophrenia, including Japanese patients, this open-label study evaluated the safety and efficacy of a 52-week treatment with asenapine at flexible doses. In 201 subjects, including 44 who had received placebo (P/A group) and 157 who had received asenapine (A/A group) in the feeder trial, adverse events occurred at rates of 90.9% and 85.4% and serious adverse events at rates of 11.4% and 20.4%, respectively. One patient in the P/A group died. No clinically significant abnormal measurements of body weight, body mass index, or glycated hemoglobin, fasting plasma glucose, insulin, and prolactin levels were observed. The sustained efficacy rate, as evaluated by the Positive and Negative Syndrome Scale total score and other measures, remained at approximately 50% between 6 and 12 months of treatment. These results suggest that long-term treatment with asenapine is well tolerated and provides sustained efficacy.

Indexed as

Antipsychotic AgentsSchizophreniaDibenzocycloheptenesFollow-Up StudiesHumansAntipsychotic AgentsasenapineDibenzocycloheptenesasenapineclinical trialschizophrenia

Identifiers

PMID37232002
PMCPMC10496045
OpenAlexW4378349135

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.