Journal of child and adolescent psychopharmacology最新文献

{"title":"Antipsychotic Use During Catatonia in Youth with Neurodevelopmental Disorders and Psychotic Symptoms: A 20-Patient Case Series.","authors":"Musa Yilanli, Larrilyn Grant, Erin M Sunderland, Nadine Schwartz","doi":"10.1177/10445463261471763","DOIUrl":"https://doi.org/10.1177/10445463261471763","url":null,"abstract":"<p><strong>Objective: </strong>Catatonia in youth with neurodevelopmental disorders (NDD) may present with co-occurring psychotic symptoms and complicate medication selection, particularly when catatonic symptoms persist despite benzodiazepine treatment. Pediatric evidence guiding antipsychotic use during active catatonia remains limited. We describe antipsychotic medication use and treatment patterns in a 20-patient case series of youth with NDD, catatonia, and psychotic symptoms.</p><p><strong>Methods: </strong>We performed a retrospective chart review of youth treated at Nationwide Children's Hospital between 2017 and 2025. Inclusion required documented NDD, catatonia diagnosed by child and adolescent psychiatrists using the Bush-Francis Catatonia Rating Scale, psychotic symptoms prompting antipsychotic treatment, and receipt of at least one antipsychotic. Clinical Global Impressions ratings were abstracted from clinical documentation, including baseline Clinical Global Impressions-Severity (CGI-S) and Clinical Global Impressions-Improvement (CGI-I) after benzodiazepine treatment and after the first antipsychotic trial, acknowledging that timing was not standardized. Catatonia course, predominant catatonia form, intervention sequencing, adverse effects, electroconvulsive therapy (ECT), clozapine use, and 30-day readmission were abstracted descriptively.</p><p><strong>Results: </strong>Twenty youth were included (median age 14.0 years; IQR 13.0-15.2), and 50% were female. Numeric full-scale IQ (FSIQ) values were available for 14/20 (70%); median FSIQ was 64.5 (IQR 48.5-69.0; range 43-75), and 13/14 (93%) had FSIQ < 70. Baseline severity was high (median CGI-S 6; range 5-7; <i>n</i> = 20). The catatonia course was acute in 1/20 (5%), subacute in 11/20 (55%), and chronic/relapsing in 8/20 (40%). The predominant catatonia form was mixed in 14/20 (70%), excited/agitated in 5/20 (25%), and hypoactive in 1/20 (5%). After benzodiazepine treatment, 15/20 (75%) had CGI-I ≤ 3, 4/20 (20%) had CGI-I = 4, and 1/20 (5%) had CGI-I ≥ 5. After the first antipsychotic trial, 12/20 (60%) had CGI-I ≤ 3, 6/20 (30%) had CGI-I = 4, and 2/20 (10%) had CGI-I ≥ 5. ECT was used in 12/20 (60%), and clozapine in 7/20 (35%). ECT and antipsychotic treatment were frequently concurrent or occurred within overlapping treatment phases. Thirty-day readmission occurred in 5/20 (25%).</p><p><strong>Conclusions: </strong>In this cohort, antipsychotic treatment occurred amid high baseline severity, variable catatonia trajectories, and frequent concurrent interventions. Worsening after the first antipsychotic trial was documented in a minority of patients, but findings should be interpreted cautiously given the small sample, retrospective design, absence of a control group, overlapping treatment phases, and the inability to separate medication effects from the underlying illness course. Causal attribution to any single intervention is not possible.</p>","PeriodicalId":15277,"journal":{"name":"Journal of child and adolescent psychopharmacology","volume":" ","pages":"10445463261471763"},"PeriodicalIF":1.8,"publicationDate":"2026-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148603456","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Developing a Novel Coding System for Retrospective Chart Review of Attention-Deficit/Hyperactivity Disorder, Anxiety, and Medication Adherence in Pediatric Psychiatry.","authors":"Lilia Mucka Andrew, Irene Zhang, Laura Saldana, Brianna Santoro, Nicholas Lohman, Mi-Young Ryee, Waverly Gestricht-Thompson, Kirsten Russo, Laura Willing, Ayman Saleh","doi":"10.1177/10445463261436795","DOIUrl":"10.1177/10445463261436795","url":null,"abstract":"<p><strong>Objectives: </strong>Pediatric mental health prevalence rates have increased in recent years, while gaps remain in the number of available providers. Ongoing evaluation and understanding of treatment progress and engagement are critical to psychiatric care, and these details are often documented in the electronic health record (EHR). Given the utility of retrospective chart review (RCR) as a tool for psychiatrists, we developed a coding system examining common comorbid conditions (anxiety and attention-deficit/hyperactivity disorder [ADHD]) and adherence and evaluated interrater reliability.</p><p><strong>Methods: </strong>We created a coding system with a comprehensive manual and coding instructions that explore both symptom severity domains (anxiety, ADHD, and global) and adherence to medication. Codes were rated using Likert scales, and two independent raters coded all data.</p><p><strong>Results: </strong>RCR was completed for 142 patients with a total of 1139 visits over 2 years. Weighted linear kappa statistics ranged between 0.77 and 0.95, and weighted quadratic kappa statistics ranged between 0.74 and 0.96, suggesting substantial to almost perfect agreement. Interrater agreement was highest for anxiety severity.</p><p><strong>Conclusions: </strong>We created a novel coding system for RCR and found substantial to almost perfect interrater reliability for assessing ADHD severity, anxiety severity, global severity, and medication adherence using psychiatry encounter notes documented in an EHR. Our coding system explores conditions that are often heterogeneous and have waxing and waning presentations, using a continuum that captures the complexity of symptoms. Future directions include utilization of coding systems to explore emotion and behavior change over time to optimize treatment.</p>","PeriodicalId":15277,"journal":{"name":"Journal of child and adolescent psychopharmacology","volume":" ","pages":"304-309"},"PeriodicalIF":1.8,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147491124","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"<i>Letter:</i> Without a Broader Understanding of the Variables Involved in the Brain-Gut Axis, Probiotics Use Is still an Open Question.","authors":"Maria Eduarda Pereira Fernandes, Emilly Sampaio de Lima, Elisa Hellen Cruz Rodrigues, Gabriella Macedo Alencar, Matheus Louro Filomeno, Isabelle Arruda Cavalcante Souza, Luísa Weber Bisol","doi":"10.1177/10445463261447842","DOIUrl":"10.1177/10445463261447842","url":null,"abstract":"","PeriodicalId":15277,"journal":{"name":"Journal of child and adolescent psychopharmacology","volume":" ","pages":"319-320"},"PeriodicalIF":2.2,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147856473","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Application of Gut Microbiota in the Treatment and Efficacy Evaluation of Tic Disorders: A Systematic Review.","authors":"Bingxue Cao, Xiaoping Zhou, Xinyi Cao, Junwei Shi, Chunyu Liu, Bin Yuan","doi":"10.1177/10445463261445906","DOIUrl":"10.1177/10445463261445906","url":null,"abstract":"<p><strong>Objective: </strong>To systematically review existing evidence on the role of gut microbiota in the pathogenesis of tic disorders (TD) and to assess the therapeutic potential of microbiome-targeted interventions such as probiotics and fecal microbiota transplantation in the management of TD.</p><p><strong>Methods: </strong>A comprehensive search was conducted in PubMed, Web of Science, EMBASE, and The Cochrane Library (up to May 26, 2025). The review followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidelines and was registered in PROSPERO (CRD420251067880).</p><p><strong>Results: </strong>Eleven studies were included, with four focusing on gut microbiome-based therapies and seven studies with gut microbiota and its metabolites as outcome indicators. At the genus level, children with TD exhibited specific alterations in gut microbiota: increased abundance of Bacteroides, Faecalibacterium, and Ruminococcus, alongside decreased levels of Bifidobacterium and Prevotella. This functional dysbiosis may trigger neuroinflammation via disrupted short-chain fatty acid metabolism and impaired intestinal barrier function, ultimately disturbing the glutamate and γ-aminobutyric acid neurotransmitter balance and leading to dysfunction in the cortico-striato-thalamo-cortical circuit. Meanwhile, probiotics as an intervention have been consistently reported to alleviate tic symptoms, although clinical evidence remains limited.</p><p><strong>Conclusion: </strong>Gut microbiota may contribute to TD pathogenesis via immune modulation and neurotransmitter metabolism. While microbiota-based strategies show promise, heterogeneity and methodological limitations in current studies necessitate further high-quality research to validate mechanisms and support clinical application.</p>","PeriodicalId":15277,"journal":{"name":"Journal of child and adolescent psychopharmacology","volume":" ","pages":"257-265"},"PeriodicalIF":2.2,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147772254","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy of Centanafadine for Executive Functioning and Learning Problems in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder.","authors":"Timothy E Wilens, Dorothee Oberdhan, Na Jin, Taisa Skubiak, Ann C Childress, Judy van Stralen, Caroline L Ward","doi":"10.1177/10445463261441745","DOIUrl":"10.1177/10445463261441745","url":null,"abstract":"<p><strong>Objective: </strong>The objective of these analyses was to evaluate the efficacy of centanafadine for treatment of attention-deficit/hyperactivity disorder (ADHD) associated features of executive functioning and learning problems measured over 6 weeks in children and adolescents with ADHD.</p><p><strong>Methods: </strong>Two phase 3, randomized, double-blind, placebo-controlled trials were conducted in children and adolescents with a primary diagnosis of ADHD at sites in the United States and Canada. Data presented here are from the total population of children aged 6-12 years (NCT05428033) or adolescents aged 13-17 years (NCT05257265) who received high-dose centanafadine or placebo for 6 weeks. Secondary and other efficacy endpoints assessed change from baseline in the Conners 3-Parent Short Executive Functioning and Learning Problems Content Scale T-scores and the Conners 3-Self-report Short Learning Problems Content Scale T-scores, all analyzed using a mixed-effect model for repeated measures. Clinically meaningful within-patient change and findings from a caregiver and/or adolescent self-report exit survey are also presented.</p><p><strong>Results: </strong>Overall, 76.5% (367/480) of children (mean age 9.2 years, 41.7% female) and 80.8% (371/459) of adolescents (mean age 14.7 years, 40.7% female) completed their respective studies. There were clinically significant improvements with centanafadine treatment observed as early as Week 1 in the Conners 3-Parent Short Executive Functioning (T-score least squares mean change from baseline [standard error] to Week 6: children, -6.8 [1.1] vs. -11.3 [1.1], <i>p</i> = 0.0026 and adolescents, -8.1 [1.0] vs. -13.0 [1.0], <i>p =</i> 0.0003) and Learning Problems content scale T-scores when compared to placebo (children, -8.2 [1.0] vs. -2.8 [0.9], <i>p</i> < 0.0001 and adolescents, -8.0 [0.9] vs. -3.1 [0.9], <i>p</i> < 0.0001). Similar changes from baseline were observed by adolescent self-report (-6.1 [0.9] vs. -2.5 [0.9], <i>p =</i> 0.0023). Compared to placebo, there was a 50% and 88% greater chance of experiencing clinically meaningful within-patient change in executive functioning for children and adolescents, respectively, and a 79% and 81% chance for experiencing clinically meaningful within-patient change in learning problems, respectively. Exit survey data support findings from clinical outcome measures.</p><p><strong>Conclusions: </strong>In addition to its impact on the core symptoms of ADHD, centanafadine improved executive functioning, learning problems, and impact on daily tasks in children and adolescents with ADHD.</p>","PeriodicalId":15277,"journal":{"name":"Journal of child and adolescent psychopharmacology","volume":" ","pages":"266-277"},"PeriodicalIF":2.2,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147645371","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Relationships Between Cognitive Disengagement Syndrome, Impulsivity, and Emotion Regulation Among Adolescents.","authors":"Gülsüm Yitik Tonkaz, Gonca Özyurt, Ali Çakir, Hakan Öğütlü, Bedia Sultan Önal, Cansu Çobanoğlu Osmanli, Berkan Şahin, Ali Evren Tufan","doi":"10.1177/10445463261418479","DOIUrl":"10.1177/10445463261418479","url":null,"abstract":"<p><strong>Objective: </strong>Cognitive disengagement syndrome (CDS) is associated with internalizing symptoms, emotion regulation (ER) difficulties, daytime sleepiness, and impulsivity; however, their interrelations in adolescents with subthreshold attention-deficit/hyperactivity disorder (ADHD) remain underexamined. This study aimed to evaluate the relationships between CDS, ADHD symptoms, ER problems, daytime sleepiness, trait impulsivity, and internalizing symptoms and to determine the mediating roles of ER problems and daytime sleepiness.</p><p><strong>Methods: </strong>This cross-sectional, clinic-based study included 144 treatment-naïve adolescents (12-18 years) referred for inattention and/or hyperactivity/impulsivity complaints. Parent-reported measures (<i>Conners Parent Rating Scale-Revised-Short Form (CPRS-R-SF)</i>; <i>Child and Adolescent Behavior Inventory-Sluggish Cognitive Tempo Scale [(CABI-SCT]</i>) and adolescent self-reports (<i>Pediatric Daytime Sleepiness Scale [PDSS]</i>, <i>Revised Child Anxiety and Depression Scale-Child Version [RCADS-CV]</i>, <i>Difficulties in Emotion Regulation Scale-Short Form [DERS-16]</i>, <i>Barratt Impulsiveness Scale-Brief</i>) were administered. Pearson correlations with Bonferroni-Holm correction and structural equation modeling were performed. The CPRS ADHD index and CABI-SCT served as predictors, DERS-16 and PDSS as mediators, RCADS-CV-Total as the outcome, and trait impulsivity, sex, and socioeconomic status were included as confounders.</p><p><strong>Results: </strong>CDS showed moderate-to-high correlations with ADHD indices and significant associations with all internalizing domains except separation anxiety. CDS and daytime sleepiness were moderately correlated, and both were significantly associated with ER difficulties. Trait impulsivity correlated with CDS, ER problems, and internalizing symptoms. CDS was associated with internalizing symptoms through an indirect pathway involving ER difficulties, whereas daytime sleepiness did not a significant mediating effect. Trait impulsivity significantly predicted CDS, ADHD symptoms, ER difficulties, and daytime sleepiness, supporting its role as a shared vulnerability factor.</p><p><strong>Conclusion: </strong>CDS symptoms appear more closely related to ER difficulties and internalizing symptoms than subthreshold ADHD symptoms in clinically referred adolescents. ER problems may represent a key mechanism linking CDS to internalizing psychopathology. Routine assessment of CDS symptoms, ER skills, and sleep-related problems may facilitate early identification of at-risk youth. Interventions targeting ER skills and sleep-related processes may represent potential targets for future interventional research, and that longitudinal studies using multimethod assessments are needed to clarify causal pathways.</p>","PeriodicalId":15277,"journal":{"name":"Journal of child and adolescent psychopharmacology","volume":" ","pages":"310-318"},"PeriodicalIF":1.8,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146113207","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Long-Acting Injectable Antipsychotics and Time to Readmission in Early Psychosis.","authors":"Caroline Wang, Sean Lynch, Chaden Noureddine, Natalie Burlant, Nishtha Ahuja, Koki Haruguchi, Sungmin Hong, Manuela Zisu, Lisa Cohen, Timothy Rice, Ashley Sterchele","doi":"10.1177/10445463261440387","DOIUrl":"10.1177/10445463261440387","url":null,"abstract":"<p><strong>Background: </strong>Long-acting injectable (LAI) antipsychotics have demonstrated benefits in reducing relapse and hospitalization in psychotic disorders, yet their real-world impact in early-phase psychosis remains incompletely understood. This study examined baseline characteristics, hospitalization features, and postdischarge outcomes among young patients with early psychosis treated with LAI versus oral (PO) antipsychotics.</p><p><strong>Methods: </strong>This retrospective chart review included 229 patients under age 25 hospitalized for psychosis at a multicenter health system between 2018 and 2022. Patients receiving LAI (<i>N</i> = 144) were compared with those receiving PO antipsychotics (<i>N</i> = 85) on sociodemographic, clinical, and admission variables. The primary outcome was psychiatric readmission within 1 year of discharge. Secondary outcomes included time to readmission, which was analyzed using Kaplan-Meier survival analysis. Multivariable logistic regression evaluated whether LAI treatment independently predicted readmission after adjusting for length of stay, prior hospitalizations, and undomiciled status.</p><p><strong>Results: </strong>The LAI group was older and exhibited greater clinical and social risk, including more prior hospitalizations, higher rates of undomiciled status, and more suicide attempts. They also had longer inpatient stays and greater medication complexity during hospitalization. One-year readmission rates were similar between groups (30.6% LAI vs. 24.7% PO). Among readmitted patients, the LAI group showed longer time to readmission. In adjusted analyses, LAI treatment was not independently associated with readmission. Undomiciled status was independently associated with readmission, paradoxically in the direction of lower odds.</p><p><strong>Conclusions: </strong>For young patients with early psychosis, LAIs were preferentially prescribed to higher-risk patients but were not independently associated with reduced 1-year readmission. Comparable outcomes between groups despite greater baseline risk in the LAI cohort suggest that LAIs may partially mitigate elevated risk, though this interpretation requires prospective confirmation. Housing instability emerged as a critical determinant of readmission patterns, underscoring the need for integrated pharmacologic and social interventions in this population.</p>","PeriodicalId":15277,"journal":{"name":"Journal of child and adolescent psychopharmacology","volume":" ","pages":"297-303"},"PeriodicalIF":1.8,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13115028/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147627936","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Age-Related Patterns and Longitudinal Trends in Psychotropic Medication Use Among Commercially Insured Children with Autism Spectrum Disorder in the United States: A Claims Database Study.","authors":"Cindy M Chan, Kylie M Stitt, Samuel K Peasah, Eric M Rosenberg, Joseph N Pierri, Chester B Good","doi":"10.1177/10445463261448803","DOIUrl":"10.1177/10445463261448803","url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to describe changes in psychotropic medication use over time in commercially insured children with autism spectrum disorder (ASD) across age groups and characterize the comorbidity burden in patients with more complex treatment regimens.</p><p><strong>Methods: </strong>Using deidentified administrative claims from the Workpartners Research Reference Database, we conducted a retrospective cohort study of employee dependents aged 0-17 years with ASD followed for 3 years. Psychotropic medication use was analyzed across three age groups (0-4, 5-9, and 10-17 years). In a subgroup with high treatment complexity, defined as polypharmacy (≥3 drug classes) and/or antipsychotic use, the prevalence of various co-occurring conditions associated with ASD was also described.</p><p><strong>Results: </strong>Among 2747 children with ASD, psychotropic medication use and polypharmacy were more common in older age groups. At Year 1, 32.8% of children aged 10-17 used ≥2 drug classes concurrently, compared with 0.9% and 15.3% in the 0-4 and 5-9 age groups, respectively. From Year 1 to Year 3, medication use increased in younger children but declined in the 10-17 age group. High treatment complexity was observed in 20.5% of children (<i>n</i> = 562) over the entire 3-year study period, most frequently in the 10-17 age group. A higher prevalence of comorbidities, including attention-deficit hyperactivity disorder, mental health conditions, conduct disorders, and irritability and agitation, was observed in those with high treatment complexity compared with those without.</p><p><strong>Conclusions: </strong>Pharmacologic treatment patterns varied by age in children with ASD, and higher treatment complexity was associated with more frequent diagnoses of co-occurring psychiatric and behavioral conditions. Further understanding of longitudinal treatment trajectories should be explored in future research, such as by contextualizing treatment changes with symptom assessment and evaluating the social impact of treatment complexity.</p>","PeriodicalId":15277,"journal":{"name":"Journal of child and adolescent psychopharmacology","volume":" ","pages":"287-296"},"PeriodicalIF":1.8,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147838487","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and Safety of Extended-Release Clonidine Hydrochloride for Attention Deficit Hyperactivity Disorder in Chinese Children and Adolescents: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.","authors":"Yun Qian, Xiaoyan Ke, Feng Gao, Wenxiong Chen, Weige Wu, Yaping Li, Lijun Du, Huafang Li, Yasong Du","doi":"10.1177/10445463261437785","DOIUrl":"10.1177/10445463261437785","url":null,"abstract":"<p><strong>Introduction: </strong>Attention-deficit/hyperactivity disorder (ADHD) is a prevalent neurodevelopmental condition in children and adolescents, yet randomized controlled trial evidence supporting pharmacological treatment in Chinese populations remains limited. This study evaluated the efficacy and safety of clonidine hydrochloride extended-release tablets (CLON-XR) as monotherapies for ADHD among Chinese children and adolescents.</p><p><strong>Materials and methods: </strong>In this 6-week, multicenter, randomized, double-blind, placebo-controlled phase 3 trial, 75 patients aged 6-17 years with ADHD were assigned (2:1) to receive once-daily CLON-XR (target dosage 0.2 mg/day) or placebo. The primary endpoint was the change from baseline to week 5 in the Swanson, Nolan, and Pelham Version-IV (SNAP-IV) total score. Secondary endpoints included SNAP-IV subscales, Clinical Global Impression-Severity (CGI-S) and Improvement (CGI-I) scores, and safety assessments.</p><p><strong>Results: </strong>Compared with placebo, CLON-XR significantly improved the primary endpoint (least squares mean change in the SNAP-IV total score: -17.5 vs. -10.3; <i>p</i> = 0.0039). Significant improvements were also observed in the SNAP-IV inattention and hyperactivity/impulsivity subscales, CGI-S, and CGI-I (all <i>p</i> < 0.05). The incidence of treatment-emergent adverse events (TEAEs) in the CLON-XR group was comparable with that in the placebo group; the TEAEs were mild, and the dropout rate was low (5.3%). No serious adverse events or clinically significant vital sign abnormalities were reported.</p><p><strong>Conclusions: </strong>CLON-XR was efficacious and well tolerated in Chinese children and adolescents with ADHD, supporting its potential as a nonstimulant treatment option in this population. These findings provide evidence for ADHD management in China and suggest that further investigations in longer-term and real-world settings are needed.</p>","PeriodicalId":15277,"journal":{"name":"Journal of child and adolescent psychopharmacology","volume":" ","pages":"278-286"},"PeriodicalIF":2.2,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147627832","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"d-Amphetamine Transdermal System in Treatment of Children and Adolescents With ADHD: SKAMP Subscale Analysis and Subgroup Analysis from a Pivotal Trial.","authors":"Andrew J Cutler, Marina Komaroff, Mariacristina Castelli, Suzanne Meeves, Mahwish Khan","doi":"10.1177/10445463261434530","DOIUrl":"10.1177/10445463261434530","url":null,"abstract":"<p><strong>Objectives: </strong>d-Amphetamine transdermal system (d-ATS) is FDA-approved for treating attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients ≥6 years. In a pivotal study, d-ATS met its primary (SKAMP total score) and secondary endpoints. This analysis further evaluated d-ATS efficacy using SKAMP subscale scores and total score by subgroup.</p><p><strong>Methods: </strong>The pivotal study comprised a 5-week, open-label dose-optimization period (DOP) followed by a 2-week, randomized, cross-over double-blind treatment period (DBP). All eligible patients received d-ATS 5 mg/9 h, with weekly evaluation for dose increase and the optimal dose maintained during the DBP. Preplanned subgroup analyses of mean SKAMP total score in the DBP by optimized dose, sex, age group, ADHD type, and baseline ADHD severity were conducted. Efficacy was assessed by difference (d-ATS vs. placebo) in least-squares (LS) mean SKAMP total and subscale scores (Attention, Deportment, and Quality of Work) from a mixed-model repeated-measures (MMRM) analysis and is reported throughout as LS mean (95% confidence interval [CI]). Model-based effect sizes were calculated <i>post hoc</i>.</p><p><strong>Results: </strong>In total, 110 patients were enrolled in the DOP; 106 were randomized in the DBP. The LS mean difference in SKAMP total score of d-ATS versus placebo was -5.9 (-6.8, -5.0), with differences in subscale scores (Attention, Deportment, and Quality of Work) of -1.4 (-1.7, -1.1), -1.9 (-2.2, -1.5), and -1.3 (-1.5, -1.0), respectively. Model-based effect sizes were 0.57, 0.42, 0.43, and 0.47, respectively. Patients receiving d-ATS demonstrated improvements versus placebo in LS mean SKAMP total score at each optimized dose in both male and female patients and children and adolescents and regardless of ADHD subtype or baseline ADHD severity.</p><p><strong>Conclusions: </strong>Consistent efficacy of d-ATS across subgroups and all SKAMP subscale scores suggests broad utility of d-ATS in all patients, regardless of age, sex, ADHD type, or baseline ADHD severity, and broad applicability of these results to patients with varying clinical presentations of functional impairment by ADHD.</p>","PeriodicalId":15277,"journal":{"name":"Journal of child and adolescent psychopharmacology","volume":" ","pages":"193-199"},"PeriodicalIF":1.8,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147608959","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}