Evidence map›Paper›PMID 30122926›Full record

ArticleNeuropsychiatric disease and treatment2018

Post hoc analyses of asenapine treatment in pediatric patients with bipolar I disorder: efficacy related to mixed or manic episode, stage of illness, and body weight.

Robert L Findling, Willie Earley, Trisha Suppes, Mehul Patel, Xiao Wu, Cheng-Tao Chang, Roger S McIntyre

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Neuropsychiatric disease and treatment, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01244815 (Efficacy and Safety of 3-Week Fixed-Dose Asenapine Treatment in Pediatric Acute Manic or Mixed Episodes Associated With Bipolar I Disorder), which is not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 30% 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.

NCT01244815 phase3completednot on this map

Efficacy and Safety of 3-Week Fixed-Dose Asenapine Treatment in Pediatric Acute Manic or Mixed Episodes Associated With Bipolar I Disorder (Protocol No. P06107)

TypeinterventionalSponsorOrganon and CoRan2011 to 2013Enrolled404ConditionsBipolar Disorder, PediatricArmsasenapine, Placebo to match asenapine, Rescue medication
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
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

7 authors at 3 institutions in 1 country.

Robert L FindlingJohns Hopkins University and the Kennedy Krieger Institute, Baltimore, MD, USA, rfindli1@jhmi.edu.
Willie EarleyAllergan, Madison, NJ, USA.
Trisha SuppesVA Palo Alto Health Care System, Palo Alto, CA, USA.
Mehul PatelAllergan, Madison, NJ, USA.
Xiao WuAllergan, Madison, NJ, USA.
Cheng-Tao ChangAllergan, Madison, NJ, USA.
Roger S McIntyreToronto Western Research Institute, Toronto, ON, Canada.
Allergan (United States) · USKennedy Krieger Institute · USVA Palo Alto Health Care System · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatient characteristics and disease progression may affect response to pharmacologic intervention in bipolar I disorder. Asenapine is approved for acute treatment of manic/mixed episodes of bipolar I disorder in patients 10-17 years old. Post hoc analyses assessed asenapine efficacy in pediatric patients by current manic or mixed episode, number of lifetime episodes, and baseline body mass index (BMI). PATIENTS AND

methodsData were obtained from a 3-week, randomized, double-blind, placebo-controlled, parallel-group trial of asenapine 2.5, 5.0, or 10.0 mg twice daily (BID) in male or female patients (10-17 years) with bipolar I disorder (NCT01244815). Patients were stratified by current episode type (

resultsIn patients with mixed episodes, differences in YMRS and CGI-BP scores were statistically significant for each asenapine dose vs placebo (

conclusionAsenapine was effective in the treatment of pediatric patients with bipolar I disorder. Efficacy did not appear to be influenced by the type of current episode, stage of disease progression, or baseline body weight/BMI.

Indexed as

adolescentasenapineatypical antipsychoticbipolar disorderchildsecond-generation antipsychotic

Identifiers

PMID30122926
PMCPMC6080865
OpenAlexW2886700386

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.