Evidence map›Paper›PMID 25999292›Full record

Trial reportEuropean child & adolescent psychiatry2016

Functional outcomes from a head-to-head, randomized, double-blind trial of lisdexamfetamine dimesylate and atomoxetine in children and adolescents with attention-deficit/hyperactivity disorder and an inadequate response to methylphenidate.

Peter Nagy, Alexander Häge, David R Coghill, Beatriz Caballero, Ben Adeyi, Colleen S Anderson, Vanja Sikirica, Esther Cardo

Open access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European child & adolescent psychiatry, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 3 pooled it
2.5field-weighted citation impact, top 12% 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

19 citing papers in PubMed, 3 syntheses or guidelines pooled it, 27 citations in OpenAlex.

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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

8 authors at 5 institutions in 5 countries.

Peter NagyVadaskert Child and Adolescent Psychiatry Hospital and Outpatient Clinic, Budapest, Hungary.
Alexander HägePaediatric Psychopharmacology, Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.
David R CoghillDivision of Neuroscience, University of Dundee, Dundee, UK.
Beatriz CaballeroShire, Eysins, Switzerland.
Ben AdeyiShire, Wayne, PA, USA.
Colleen S AndersonShire, Wayne, PA, USA.
Vanja SikiricaShire, Wayne, PA, USA.
Esther CardoNeuropaediatric Unit, Son Llàtzer Hospital and Research Institute on Health Sciences, University of the Balearic Islands, Palma De Mallorca, Spain. ecardojalon@gmail.com.
Takeda (United States) · USHeidelberg University · DEUniversitat de les Illes Balears · ESUniversity of Dundee · GBVadaskert Alapítvány a Gyermekek Lelki Egészségéért · HU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Attention-deficit/hyperactivity disorder (ADHD) is associated with functional impairments in multiple domains of patients' lives. A secondary objective of this randomized, active-controlled, head-to-head, double-blind, dose-optimized clinical trial was to compare the effects of lisdexamfetamine dimesylate (LDX) and atomoxetine (ATX) on functional impairment in children and adolescents with ADHD. Patients aged 6-17 years with an ADHD Rating Scale IV total score ≥ 28 and an inadequate response to methylphenidate treatment (judged by investigators) were randomized (1:1) to once-daily LDX or ATX for 9 weeks. Parents/guardians completed the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P) at baseline and at week 9 or early termination. p values were nominal and not corrected for multiple comparisons. Of 267 randomized patients, 200 completed the study (LDX 99, ATX 101). At baseline, mean WFIRS-P total score in the LDX group was 0.95 [standard deviation (SD) 0.474; 95% confidence interval (CI) 0.87, 1.03] and in the ATX group was 0.91 (0.513; 0.82, 1.00). Scores in all WFIRS-P domains improved from baseline to endpoint in both groups, with least-squares mean changes in total score of -0.35 (95% CI -0.42, -0.29) for LDX and -0.27 (-0.33, -0.20) for ATX. The difference between LDX and ATX was statistically significant (p < 0.05) for the Learning and School (effect size of LDX vs ATX, 0.43) and Social Activities (0.34) domains and for total score (0.27). Both treatments reduced functional impairment in children and adolescents with ADHD; LDX was statistically significantly more effective than ATX in two of six domains and in total score.

Indexed as

AdolescentAtomoxetine HydrochlorideAttentionAttention Deficit Disorder with HyperactivityCentral Nervous System StimulantsChildDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansLisdexamfetamine DimesylateMaleMethylphenidateTreatment OutcomeAtomoxetine HydrochlorideCentral Nervous System StimulantsLisdexamfetamine DimesylateMethylphenidateAtomoxetineAttention-deficit/hyperactivity disorderFunctional impairmentLisdexamfetamine dimesylateWeiss Functional Impairment Rating Scale-Parent Report

Identifiers

PMID25999292
PMCPMC4735245
OpenAlexW215407455

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.