Evidence map›Paper›PMID 18978633›Full record

Trial reportJournal of the American Academy of Child and Adolescent Psychiatry2008

Methylphenidate and amphetamine do not induce cytogenetic damage in lymphocytes of children with ADHD.

Kristine L Witt, Michael D Shelby, Nilda Itchon-Ramos, Melissa Faircloth, Grace E Kissling, Allan K Chrisman, Hima Ravi, Hemalatha Murli, Donald R Mattison, Scott H Kollins

Open access · greenAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of the American Academy of Child and Adolescent Psychiatry, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
2.9field-weighted citation impact, top 10% 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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 30 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

10 authors at 5 institutions in 2 countries.

Kristine L WittNational Toxicology Program, National Institute of Environmental Health Sciences, National Institutes of Health, Department of Health and Human Services, Triangle Park, NC 27709, USA. witt@niehs.nih.gov
Michael D Shelby
Nilda Itchon-Ramos
Melissa Faircloth
Grace E Kissling
Allan K Chrisman
Hima Ravi
Hemalatha Murli
Donald R Mattison
Scott H Kollins
Covance (United States) · USNational Institute of Environmental Health Sciences · USDuke Medical Center · USDuke University Hospital · USNational Institutes of Health · US

Funding

NIEHS Statistical Consulting ServiceZIAES045005 · NIEHS · NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES · PI PEDDADA, SHYAMAL · 2009 to 2011
$2.8M
NTP Database Summarization And EvaluationZIAES045004 · NIEHS · NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES · PI KISSLING, GRACE E · 2009 to 2017
$1.2M
Cytogenetic damage in ADHD children treated with methylphenidate or AdderallZ01ES102065 · NIEHS · NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES · PI WITT, KRISTINE L · 2006 to 2008
$74k
Intramural NIH HHS Z01 ES102065Intramural NIH HHS Z99 ES999999
6 · The paper itself

Abstract

objectiveIn response to previously published findings of methylphenidate-induced chromosomal changes in children, this study was designed to determine whether methylphenidate- or amphetamine-based drugs induce chromosomal damage (structural aberrations, micronuclei, and sister chromatid exchanges) in peripheral blood lymphocytes of children with attention-deficit/hyperactivity disorder after 3 months of continuous treatment.

methodStimulant drug-naïve subjects, 6 to 12 years of age, in good overall health, and judged to be appropriate candidates for stimulant therapy based on rigorously diagnosed ADHD using DSM-IV criteria, were randomized into two open-label treatment groups (methylphenidate or mixed amphetamine salts). Each subject provided a blood sample before initiation of treatment and after 3 months of treatment. Pretreatment and posttreatment frequencies of chromosomal aberrations, micronuclei, and sister chromatid exchanges were determined for each subject.

resultsSixty-three subjects enrolled in the study; 47 subjects completed the full 3 months of treatment, 25 in the methylphenidate group and 22 in the amphetamine group. No significant treatment-related increases were observed in any of the three measures of cytogenetic damage in the 47 subjects who completed treatment or the 16 subjects who did not.

conclusionsEarlier findings of methylphenidate-induced chromosomal changes in children were not replicated in this study. These results add to the accumulating evidence that therapeutic levels of methylphenidate do not induce cytogenetic damage in humans. Furthermore, our results indicate that amphetamine-based products do not pose a risk for cytogenetic damage in children.

Indexed as

Chromosome AberrationsMicronucleus TestsSister Chromatid ExchangeAmphetaminesAttention Deficit Disorder with HyperactivityCentral Nervous System StimulantsChildDose-Response Relationship, DrugFemaleHumansLymphocytesMaleMethylphenidateAdderallAmphetaminesCentral Nervous System StimulantsMethylphenidateSLI381

Identifiers

PMID18978633
PMCPMC2807376
OpenAlexW1987661633

What OpenQuestion holds

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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.