成人ADHDの臨床試験に深刻な欠陥が存在(Researchers find serious flaws in trials with adult ADHD patients)

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2025-06-30 コペンハーゲン大学(UCPH)

コペンハーゲン大学とサンパウロ大学の研究者らは、成人ADHDを対象とした臨床試験の方法論に深刻な欠陥があると報告しました。そこで対象となった292件のランダム化比較試験(RCT)を分析した結果、半数の研究では他の精神疾患(うつ病、統合失調症など)を除外せず、診断の信頼性が担保されていないことが明らかになりました。さらに、61%の研究で診断者の資格が不明であり、35%のみが心理士・精神科医による診断を明記。一部では被験者自身やコンピュータによる診断も行われていたことが判明しています。これらの不備により、ADHDに対する治療効果の評価が曖昧となり、臨床試験結果や診療ガイドラインの信頼性に影響が及ぶ可能性が示唆されました。研究者らは、成人ADHD研究において厳格かつ統一された診断プロトコルの必要性を強調しています。

<関連情報>

無作為化比較試験における成人のADHDの診断:スクーピングレビュー Diagnosing ADHD in adults in randomized controlled studies: a scoping review

Igor Studart[,Mads Gram Henriksen[ and Julie Nordgaard
European Psychiatry  Published:14 April 2025
DOI:https://doi.org/10.1192/j.eurpsy.2025.2447

成人ADHDの臨床試験に深刻な欠陥が存在(Researchers find serious flaws in trials with adult ADHD patients)

Abstract

Background

The diagnosis of ADHD in adults is on the rise. Applying the ADHD diagnosis, which originally was described in children, to adults has involved a “subjectivization” of some of the diagnostic criteria, i.e., some behavioral features (signs) in children have become experiences (symptoms) in adults. These issues raise the question of how ADHD is best diagnosed in adults? Thus, we examined how ADHD is diagnosed in adults in research.

Methods

A review of how ADHD is diagnosed in adults in randomized controlled studies (RCTs).

Results

We include 292 RCTs. We found substantial variation and no consensus about the diagnostic method. More than half of the studies did not seem to include an assessment of general psychopathology, and only in 35% of studies was the ADHD diagnosis allocated by psychiatrists or psychologist. More than half of the studies included patients with psychiatric comorbidity.

Conclusion

These findings raise concerns about the validity of the ADHD diagnosis in many of the included RCTs. It is worrying that securing a reasonably accurate diagnosis is not prioritized in more than half of the studies. If neither clinicians nor researchers can rely on the basic fact the patients in scientific studies diagnostically resemble the patients they are facing, scientific studies risk losing their clinical relevance. Since RCTs can lead to changes in clinical practice, they must be conducted carefully. To advance research on adult ADHD, the quality of the diagnostic assessment must be prioritized, requiring comprehensive differential diagnosis by a skilled psychiatrist or psychologist.

医療・健康
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