Evidence map›Paper›PMID 42830387›Full record

ArticleCNS drugs2026

A Phase 3, Multicenter, Randomized, Placebo-Controlled Trial Evaluating the Efficacy, Safety, and Tolerability of Serdexmethylphenidate/d-Methylphenidate Capsules in Chinese Children with Attention-Deficit/Hyperactivity Disorder.

Jing Liu, Ying Yang, Yi Wang, Jinjin Chen, Rongwang Yang, Yonghua Cui, Lili Zhang, Wenjing Liu, Fan He, Li Yang and 11 more

Registry-linked trialAbstract read
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In one paragraph

Article in CNS drugs, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06359899 (A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Investigate the Efficacy, Safety and Tolerability of Oral Administered AK0901 Capsules in Children Aged 6-12 Years Old With Attention Deficit Hyperactivity Disorder), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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.

NCT06359899 phase3completednot on this map

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Investigate the Efficacy, Safety and Tolerability of Oral Administered AK0901 Capsules in Children Aged 6-12 Years Old With Attention Deficit Hyperactivity Disorder

TypeinterventionalSponsorShanghai Ark Biopharmaceutical Co., Ltd.Ran2024 to 2025Enrolled55ConditionsADHDArmsAK0901 capsule, Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

21 authors.

Jing Liu *Child Mental Health Center, Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), Beijing Key Laboratory for Big Data Innovative Application of Child and Adolescent Mental Disorders, National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China.
Ying Yang *Child and Adolescent Psychobehavioral Medicine Center, Shandong Mental Health Center, Shandong University, Jinan, China.
Yi Wang *Department of Neurology, Children's Hospital of Fudan University, Shanghai, China.
Jinjin Chen *Child Health Care Medical Division, Shanghai Children's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Rongwang Yang *Department of Psychology, Children's Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Yonghua Cui *Psychiatry Department, Beijing Children's Hospital, Capital Medical University, Beijing, China.
Lili Zhang *Child Healthcare Department, Wuxi Children's Hospital, Wuxi, China.
Wenjing Liu *Department of Child and Adolescent Psychiatry, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Fan He *Department of Child Psychiatry, Beijing Anding Hospital, Capital Medical University, Beijing, China.
Li Yang *Child Mental Health Center, Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), Beijing Key Laboratory for Big Data Innovative Application of Child and Adolescent Mental Disorders, National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China.
Defeng Xu *Child and Adolescent Psychobehavioral Medicine Center, Shandong Mental Health Center, Shandong University, Jinan, China.
Jinhua Sun *Department of Psychiatry and Psychology, Children's Hospital of Fudan University, Shanghai, China.
Aidina Aisikeer *Child Health Care Medical Division, Shanghai Children's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Xiaoli Fan *Department of Psychology, Children's Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Jingran Liu *Psychiatry Department, Beijing Children's Hospital, Capital Medical University, Beijing, China.
Lei Wang *Child Healthcare Department, Wuxi Children's Hospital, Wuxi, China.
Zhengqi Sun *Shanghai Ark Biopharmaceutical Co., Ltd., Shanghai, China.
Tan Jia *Shanghai Ark Biopharmaceutical Co., Ltd., Shanghai, China.
Jun Qi *Shanghai Ark Biopharmaceutical Co., Ltd., Shanghai, China.
Jim Z WuShanghai Ark Biopharmaceutical Co., Ltd., Shanghai, China. jim.wu@arkbiosciences.com.
Yi ZhengDepartment of Child Psychiatry, Beijing Anding Hospital, Capital Medical University, Beijing, China. yizheng@ccmu.edu.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveSerdexmethylphenidate/dexmethylphenidate (SDX/d-MPH) is a novel methylphenidate formulation designed to provide rapid onset and sustained symptom control in attention-deficit/hyperactivity disorder (ADHD). This phase 3 study evaluated its efficacy, safety, and tolerability in Chinese children with ADHD.

methodsThis multicenter, randomized, double-blind, placebo-controlled bridging study enrolled children aged 6-12 years who met DSM-5 criteria for ADHD. The primary endpoint was least squares mean (LSM) change from baseline to week 3 in ADHD Rating Scale-5 (ADHD-RS-5) total score, an 18-item DSM-5-based scale rating symptoms from 0 (never/rarely) to 3 (very often). Secondary endpoints included change from baseline to week 4 in ADHD-RS-5, and weekly changes in Clinical Global Impressions-Severity (CGI-S), Clinical Global Impressions-Improvement (CGI-I), and Weekly Ratings of Evening and Morning Behavior-Revised (WREMB-R). Safety was assessed throughout the study.

resultsOverall, 55 participants were randomized (SDX/d-MPH, n = 28; placebo, n = 27). At week 3, SDX/d-MPH demonstrated significantly greater improvement in ADHD-RS-5 total score versus placebo (between-group LSM change [standard error]: - 5.8 [2.58], p = 0.0292), with an effect size of 0.61, meeting the prespecified efficacy consistency criterion (≥ 0.25). At week 4, significant improvements versus placebo were observed across ADHD-RS-5 total score (- 8.4 [2.69]), inattention and hyperactivity-impulsivity sub-scores (- 4.4 [1.69] and - 3.7 [1.27], respectively), CGI-S (- 0.8 [0.28]), CGI-I (0.9 [0.27]), and WREMB-R total (- 3.7 [1.35]) and evening scores (- 3.2 [1.03]). Most treatment-emergent adverse events were mild to moderate, with no new safety signals.

conclusionsSDX/d-MPH significantly improved ADHD symptoms and was generally well tolerated in Chinese children, supporting extension of global trial results to this population. CLINICALTRIALS: gov identifier: NCT06359899 (registered on 25 March 2024).

Identifiers

PMID42830387

What Socratic holds

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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 Socratic graph.