Journal of child and adolescent psychopharmacology最新文献

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Psychiatric Polygenic Risk Scores and Week-by-Week Symptomatic Status in Youth with Bipolar Disorder: An Exploratory Study. 双相情感障碍青少年的精神病多基因风险评分和逐周症状状态:一项探索性研究。
IF 1.5 4区 医学
Journal of child and adolescent psychopharmacology Pub Date : 2025-03-10 DOI: 10.1089/cap.2024.0130
Xinyue Jiang, Clement C Zai, John Merranko, L Trevor Young, Boris Birmaher, Benjamin I Goldstein
{"title":"Psychiatric Polygenic Risk Scores and Week-by-Week Symptomatic Status in Youth with Bipolar Disorder: An Exploratory Study.","authors":"Xinyue Jiang, Clement C Zai, John Merranko, L Trevor Young, Boris Birmaher, Benjamin I Goldstein","doi":"10.1089/cap.2024.0130","DOIUrl":"https://doi.org/10.1089/cap.2024.0130","url":null,"abstract":"<p><p><b><i>Introduction:</i></b> Prior studies have demonstrated that, in both adults and youth, bipolar disorder (BD) is a polygenic illness. However, no studies have examined polygenic risk scores (PRSs) in relation to the longitudinal course of mood symptoms in youth with BD. <b><i>Methods:</i></b> This study included 246 youth of European ancestry with BD (7-20 years old at intake) from the Course and Outcome of Bipolar Youth study and Centre for Youth Bipolar Disorder. Mood symptom severity was assessed at intake and, for 168 participants, prospectively for a median of 8.7 years. PRSs for BD, schizophrenia (SCZ), major depressive disorder (MDD), and attention-deficit/hyperactivity disorder (ADHD) were constructed using genome-wide summary statistics from independent adult cohorts. <b><i>Results:</i></b> Higher BD-PRS was significantly associated with lower most severe lifetime depression score at intake (<i>β</i> = -0.14, <i>p</i> = 0.03). Higher SCZ-PRS and MDD-PRS were associated with significantly less time spent in euthymia (SCZ-PRS: <i>β</i> = -0.21, <i>p</i> = 0.02; MDD-PRS: <i>β</i> = -0.22, <i>p</i> = 0.01) and more time with any subsyndromal mood symptoms (i.e., any mania, mixed, or depression symptoms; SCZ-PRS: <i>β</i> = 0.15, <i>p</i> = 0.04; MDD-PRS: <i>β</i> = 0.17, <i>p</i> = 0.01) during follow-up. PRSs for BD and ADHD were not significantly associated with any longitudinal mood variable. <b><i>Conclusions:</i></b> This exploratory analysis was the first to examine psychiatric PRSs in relation to the prospective course of mood symptoms among youth with BD. Results from the current study can serve to guide future youth BD studies with larger sample sizes on this topic.</p>","PeriodicalId":15277,"journal":{"name":"Journal of child and adolescent psychopharmacology","volume":" ","pages":""},"PeriodicalIF":1.5,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143585863","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}
引用次数: 0
Medication Prescribing Patterns at a Youth Mental Health Service: A Single Center Retrospective Cross-sectional Study.
IF 1.5 4区 医学
Journal of child and adolescent psychopharmacology Pub Date : 2025-03-10 DOI: 10.1089/cap.2024.0140
Angela Dinh, Sarira El-Den, Jack C Collins, Blake Hamilton, Connie M S Janiszewski, Donna Fowler, Claire L O'Reilly
{"title":"Medication Prescribing Patterns at a Youth Mental Health Service: A Single Center Retrospective Cross-sectional Study.","authors":"Angela Dinh, Sarira El-Den, Jack C Collins, Blake Hamilton, Connie M S Janiszewski, Donna Fowler, Claire L O'Reilly","doi":"10.1089/cap.2024.0140","DOIUrl":"https://doi.org/10.1089/cap.2024.0140","url":null,"abstract":"<p><p><b><i>Objective:</i></b> Rates of mental illness among young people remain elevated, and the utilization of youth mental health services is expected to increase. Yet, there is limited knowledge on real-world medication usage and prescribing at these services. Hence, the aim of this study was to explore the medication prescribing patterns at a <i>headspace</i> center, an Australian youth mental health service. <b><i>Methods:</i></b> A retrospective cross-sectional study of medical records was conducted. Demographic data, clinical information, prescribed medications, and reasons for use of young people who attended an intake assessment at <i>headspace</i> Camperdown over a 13-month period, February 2021-February 2022, were analyzed. Data collection focused on medication molecule, strength, dose, prescriber designation, and indication. Data were analyzed descriptively. <b><i>Results:</i></b> Records for 608 participants were included. The median age at intake was 19.9 years old (interquartile range: 16.1-22.4), and most participants identified as female (<i>n</i> = 372, 61.2%). Anxiety (<i>n</i> = 246, 40.5%) and low mood (<i>n</i> = 95, 15.6%) were the most common presenting concerns. Almost half of participants (<i>n</i> = 291, 47.9%) reported using medication/s at intake, and almost one in five participants (<i>n</i> = 119, 19.6%) were prescribed a medication at the service. The most prescribed medications at <i>headspace</i> were melatonin (24.0%) and quetiapine (12.3%), as well as the antidepressants escitalopram (15.1%), sertraline (11.2%), and fluoxetine (7.3%). <b><i>Conclusions:</i></b> This study provides insights into the prescribing practices at a single <i>headspace</i> center. Further investigations are needed to explore the impacts of off-label prescribing for young people, particularly in relation to melatonin and quetiapine, where safety and efficacy in young people have not been well established.</p>","PeriodicalId":15277,"journal":{"name":"Journal of child and adolescent psychopharmacology","volume":" ","pages":""},"PeriodicalIF":1.5,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143585862","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}
引用次数: 0
From the Editor-in-Chief's Desk: Psychedelic Therapeutics-Something Old and Something New.
IF 1.5 4区 医学
Journal of child and adolescent psychopharmacology Pub Date : 2025-03-10 DOI: 10.1089/cap.2025.03425.edt
Paul E Croarkin
{"title":"From the Editor-in-Chief's Desk: Psychedelic Therapeutics-Something Old and Something New.","authors":"Paul E Croarkin","doi":"10.1089/cap.2025.03425.edt","DOIUrl":"https://doi.org/10.1089/cap.2025.03425.edt","url":null,"abstract":"","PeriodicalId":15277,"journal":{"name":"Journal of child and adolescent psychopharmacology","volume":" ","pages":""},"PeriodicalIF":1.5,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143585861","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}
引用次数: 0
Treat to Sedation: Managing Intravenous Placement for Electroconvulsive Therapy in Autism with Intellectual Disability and Hyperactive Catatonia.
IF 1.5 4区 医学
Journal of child and adolescent psychopharmacology Pub Date : 2025-03-05 DOI: 10.1089/cap.2025.0012
Aparna Srinivasan, James Luccarelli, Rafael Tamargo, Timothy Adegoke, Joshua R Smith
{"title":"Treat to Sedation: Managing Intravenous Placement for Electroconvulsive Therapy in Autism with Intellectual Disability and Hyperactive Catatonia.","authors":"Aparna Srinivasan, James Luccarelli, Rafael Tamargo, Timothy Adegoke, Joshua R Smith","doi":"10.1089/cap.2025.0012","DOIUrl":"https://doi.org/10.1089/cap.2025.0012","url":null,"abstract":"<p><p><b><i>Purpose:</i></b> Catatonia is a severe psychomotor and mood-related disorder, which can significantly impact the quality of life for autistic individuals. Often, electroconvulsive therapy (ECT) is required for treatment of catatonia in autism. However, hyperactive, impulsive, and aggressive symptoms are common in this subpopulation. Thus, pharmacologic agents are needed to assist in obtaining intravenous (IV) access and placement of necessary monitoring leads when ECT is pursued. Here we report six patients with autism and hyperactive catatonia who successfully and safely received intramuscular (IM) ketamine to obtain IV access for ECT while prescribed high-dose benzodiazepines for catatonia. <b><i>Methods:</i></b> Using SlicerDicer software found within Epic Systems electronic medical record, we conducted a single-site retrospective analysis. All patients had a diagnosis of autism, were treated for hyperactive catatonia with ECT, and required the use of ketamine for safe IV placement. Diagnoses of autism and catatonia were confirmed per the fifth edition of the <i>Diagnostic and Statistical Manual of Mental Disorders</i>. <b><i>Results:</i></b> Six patients were identified. All patients met criteria for autism, intellectual disability, and catatonia. The patient's ages ranged from 10 to 30 years, and all were prescribed high doses of benzodiazepines for treatment of catatonia, with a mean dose of 24 mg per day in lorazepam equivalents. The patients' symptoms of hyperactive catatonia impaired the ability to obtain IV access. Thus, IM ketamine was received by all patients to facilitate this process. All patients were able to receive ECT. <b><i>Conclusion:</i></b> In all cases, IM ketamine was successfully used to obtain IV access and allow patients to receive ECT uneventfully. No serious adverse events were reported despite the coadministration of ketamine with high-dose benzodiazepines in this patient subpopulation.</p>","PeriodicalId":15277,"journal":{"name":"Journal of child and adolescent psychopharmacology","volume":" ","pages":""},"PeriodicalIF":1.5,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143557058","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}
引用次数: 0
Myths of Randomized Controlled Trial Analysis in Pediatric Psychopharmacology.
IF 1.5 4区 医学
Journal of child and adolescent psychopharmacology Pub Date : 2025-03-03 DOI: 10.1089/cap.2025.0005
Jeffrey A Mills, Jeffrey R Strawn
{"title":"Myths of Randomized Controlled Trial Analysis in Pediatric Psychopharmacology.","authors":"Jeffrey A Mills, Jeffrey R Strawn","doi":"10.1089/cap.2025.0005","DOIUrl":"https://doi.org/10.1089/cap.2025.0005","url":null,"abstract":"","PeriodicalId":15277,"journal":{"name":"Journal of child and adolescent psychopharmacology","volume":" ","pages":""},"PeriodicalIF":1.5,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143604868","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}
引用次数: 0
Viloxazine Extended-Release Administered With Psychostimulants in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder: A Phase 4, Open-Label Trial.
IF 1.5 4区 医学
Journal of child and adolescent psychopharmacology Pub Date : 2025-02-27 DOI: 10.1089/cap.2024.0138
Ann Childress, Kobby Asubonteng, Georgette Cox, Jami Earnest, Kimberley Hayman, Ilmiya Yarullina, Jonathan Rubin
{"title":"Viloxazine Extended-Release Administered With Psychostimulants in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder: A Phase 4, Open-Label Trial.","authors":"Ann Childress, Kobby Asubonteng, Georgette Cox, Jami Earnest, Kimberley Hayman, Ilmiya Yarullina, Jonathan Rubin","doi":"10.1089/cap.2024.0138","DOIUrl":"https://doi.org/10.1089/cap.2024.0138","url":null,"abstract":"<p><p><b><i>Introduction:</i></b> Viloxazine extended-release (VLX-ER) is effective as monotherapy for attention-deficit/hyperactivity disorder (ADHD), and is often tried as an add-on treatment when psychostimulant therapy fails to provide an adequate treatment response. This phase 4, open-label study evaluated safety, tolerability, and efficacy of VLX-ER with optimized psychostimulants in pediatric participants with ADHD. Morning versus evening VLX-ER use was also evaluated. <b><i>Methods:</i></b> Children and adolescents (6-17 years) experiencing inadequate psychostimulant response (investigator-assessed ADHD Rating Scale-5 [ADHD-RS-5] score ≥24 and Clinical Global Impression-Severity of Illness [CGI-S] scores ≥3) during a 4-week screening period received flexibly-dosed VLX-ER, taken once daily in the morning (weeks 14) or evening (weeks 5-8), concomitantly with a psychostimulant. Safety (primary outcome) and efficacy were evaluated relative to baseline. <b><i>Results:</i></b> Fifty-six participants (26 children; 30 adolescents) enrolled, and 48 (85.7%) completed the study. Combination therapy was well tolerated, with only two participants (3.6%) withdrawing due to adverse events (AEs). The most commonly reported AEs were headache (17.9%), decreased appetite (12.5%), and upper respiratory tract infection (10.7%). Mean ± standard deviation investigator-assessed ADHD-RS-5 scores (baseline: 37.2 ± 8.4) improved progressively by -13.5 ± 9.7 points at week 4 and -18.2 ± 10.0 points at week 8 (<i>p</i> < 0.0001 each). Likewise, CGI-S scores (baseline: 4.4 ± 0.6) improved by -0.9 ± 0.9 at week 4 and -1.4 ± 1.1 at week 8 (<i>p</i> < 0.0001 each). Parent-assessed scales, including ratings of morning and evening ADHD behaviors and sleep disturbances, showed significant improvement relative to baseline regardless of morning (week 4) or evening (week 8) VLX-ER dosing. <b><i>Conclusion:</i></b> Combined treatment with VLX-ER and psychostimulant therapy showed acceptable safety and tolerability, with improvement in morning and evening ADHD behaviors and sleep disturbances relative to stimulant monotherapy. Timing of VLX-ER administration (morning or evening) did not appear to affect safety, drug response, or sleep improvement.</p>","PeriodicalId":15277,"journal":{"name":"Journal of child and adolescent psychopharmacology","volume":" ","pages":""},"PeriodicalIF":1.5,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143523133","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}
引用次数: 0
From the Editor-in-Chief's Desk: Psychedelic Therapeutics-Something Old and Something New.
IF 1.5 4区 医学
Journal of child and adolescent psychopharmacology Pub Date : 2025-02-24 DOI: 10.1089/cap.2025.0017
Paul E Croarkin
{"title":"From the Editor-in-Chief's Desk: Psychedelic Therapeutics-Something Old and Something New.","authors":"Paul E Croarkin","doi":"10.1089/cap.2025.0017","DOIUrl":"https://doi.org/10.1089/cap.2025.0017","url":null,"abstract":"","PeriodicalId":15277,"journal":{"name":"Journal of child and adolescent psychopharmacology","volume":" ","pages":""},"PeriodicalIF":1.5,"publicationDate":"2025-02-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143483149","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}
引用次数: 0
Safety Outcomes from a Long-Term, Prospective Study of Sertraline Use in Children and Adolescents: The Sertraline Pediatric Registry for the Evaluation of Safety.
IF 1.5 4区 医学
Journal of child and adolescent psychopharmacology Pub Date : 2025-02-20 DOI: 10.1089/cap.2024.0054
Sara Ramaker, Francesca Kolitsopoulos, Lisa Ludwig, Scott N Compton, Samuel Broderick, John Orazem, Weihang Bao, Yuliya Lokhnygina, Sarah Hackley, Phillip Chappell
{"title":"Safety Outcomes from a Long-Term, Prospective Study of Sertraline Use in Children and Adolescents: The Sertraline Pediatric Registry for the Evaluation of Safety.","authors":"Sara Ramaker, Francesca Kolitsopoulos, Lisa Ludwig, Scott N Compton, Samuel Broderick, John Orazem, Weihang Bao, Yuliya Lokhnygina, Sarah Hackley, Phillip Chappell","doi":"10.1089/cap.2024.0054","DOIUrl":"https://doi.org/10.1089/cap.2024.0054","url":null,"abstract":"<p><p><b><i>Objectives:</i></b> To describe the Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES) safety results, including adverse events (AEs) (serious and nonserious, including suicide-related events) following long-term treatment with sertraline in children and adolescents aged 6-16 years. <b><i>Methods:</i></b> SPRITES was a multicenter, prospective, observational study designed to compare cognitive, emotional, and physical development in pediatric patients exposed to sertraline or psychotherapy alone in routine care for up to 3 years. Safety outcomes included AEs collected on the Pediatric Adverse Event Rating Scale and suicidal ideation/behavior (SIB), as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS). AEs (unadjusted and adjusted for exposure) and C-SSRS data were summarized descriptively, and a marginal structural model (MSM) was applied to the C-SSRS results. <b><i>Results:</i></b> Between April 2012 and September 2020, 941 patients participated in SPRITES. At baseline, per treating physician discretion, 695 patients were administered sertraline, 243 patients were administered psychotherapy alone, and 3 patients were administered an antidepressant other than sertraline. At postbaseline timepoints, patients receiving sertraline reported higher overall rates of AEs relative to the other antidepressants and nonpharmacologic treatment groups. The most common AEs in the sertraline group were related to psychiatric and gastrointestinal disorders. In all exposure groups, the incidence of AEs and SIB decreased across study timepoints. MSM analyses did not demonstrate an effect of sertraline treatment on new onset or worsening SIB. <b><i>Conclusion:</i></b> The safety profile of sertraline in a long-term, real-world setting is similar to that of prior pediatric sertraline studies. A greater proportion of AEs and SIB events reported in the sertraline group compared with the nonpharmacologic therapy group is not unexpected given the safety profile of sertraline and observation of baseline differences in psychiatric disease severity between exposure groups. With prolonged sertraline treatment, incidence rates of AEs and SIB events decreased, and worsening of SIB was not observed.</p>","PeriodicalId":15277,"journal":{"name":"Journal of child and adolescent psychopharmacology","volume":" ","pages":""},"PeriodicalIF":1.5,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143458159","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}
引用次数: 0
Safety and Efficacy of Brexpiprazole in the Treatment of Irritability Associated with Autism Spectrum Disorder: An 8-Week, Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial and 26-Week Open-Label Extension in Children and Adolescents.
IF 1.5 4区 医学
Journal of child and adolescent psychopharmacology Pub Date : 2025-02-19 DOI: 10.1089/cap.2024.0118
Caroline Ward, Ann Childress, Krista Martinko, Dalei Chen, Klaus Groes Larsen, Alpesh Shah, Pamela Sheridan, Nanco Hefting, James Knutson
{"title":"Safety and Efficacy of Brexpiprazole in the Treatment of Irritability Associated with Autism Spectrum Disorder: An 8-Week, Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial and 26-Week Open-Label Extension in Children and Adolescents.","authors":"Caroline Ward, Ann Childress, Krista Martinko, Dalei Chen, Klaus Groes Larsen, Alpesh Shah, Pamela Sheridan, Nanco Hefting, James Knutson","doi":"10.1089/cap.2024.0118","DOIUrl":"https://doi.org/10.1089/cap.2024.0118","url":null,"abstract":"<p><p><b><i>Introduction:</i></b> The effective management of irritability is a key need in young people with autism spectrum disorder (ASD). We evaluated the efficacy and safety of brexpiprazole in children and adolescents with irritability associated with ASD. <b><i>Methods:</i></b> This was an 8-week, phase 3, randomized, double-blind, placebo-controlled trial (NCT04174365) and 26-week, open-label extension (OLE, NCT04258839) of brexpiprazole (0.25-3 mg/day based on body weight) in children and adolescents (5-17 years) with a diagnosis of ASD, score ≥18 on the Aberrant Behavior Checklist-Irritability (ABC-I) subscale, and score ≥4 on the Clinical Global Impressions-Severity scale. <b><i>Results:</i></b> Of the 119 randomized participants (brexpiprazole = 60, placebo = 59), 104 completed double-blind treatment, and 95 enrolled and 70 completed the OLE. Similar reductions in mean ABC-I subscale score were seen in both groups (least-squares mean ± standard error reduction from double-blind baseline of -10.1 ± 1.3 with brexpiprazole vs -8.9 ± 1.3 with placebo). Thus, the primary endpoint did not show a significant treatment effect (LS-mean [95% confidence interval] treatment difference: -1.22 [-4.49, 2.05], <i>p</i> = 0.46) and the hierarchical efficacy analysis ended at this point. At the end of the OLE, participants had a mean ± SD reduction from open-label baseline of -6.1 ± 8.2 in ABC-I subscale score. During double-blind treatment, 51.7% participants treated with brexpiprazole had ≥1 treatment-emergent adverse event (TEAE) versus 35.1% with placebo; no severe or serious TEAEs were reported. The only potentially treatment-related TEAE that occurred in ≥5% of participants was somnolence (12.1% for brexpiprazole vs 5.3% for placebo). During the OLE, the most commonly reported TEAE was increased weight (<i>n</i> = 13, 13.7%). <b><i>Conclusions</i></b>: Treatment with brexpiprazole did not demonstrate significant efficacy versus placebo for the treatment of irritability associated with ASD. The safety profile was consistent with that observed in adult and adolescent patients with schizophrenia.</p>","PeriodicalId":15277,"journal":{"name":"Journal of child and adolescent psychopharmacology","volume":" ","pages":""},"PeriodicalIF":1.5,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143458157","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}
引用次数: 0
Predictors of Placebo Response in the Study of Oxytocin in Autism to Improve Reciprocal Social Behaviors.
IF 1.5 4区 医学
Journal of child and adolescent psychopharmacology Pub Date : 2025-02-19 DOI: 10.1089/cap.2024.0131
Alyssa Verdes, Suvekcha Bhattachan, Alexander Kolevzon, Bryan H King, Christopher J McDougle, Kevin B Sanders, Soo-Jeong Kim, Marina Spanos, Tara Chandrasekhar, Carol Rockhill, Michelle Palumbo, Mendy Minjarez, Lisa Nowinski, Sarah Marler, Stephen Siecinski, Stephanie Giamberardino, Simon G Gregory, Jeremy Veenstra-VanderWeele, Linmarie Sikich, Amandeep Jutla
{"title":"Predictors of Placebo Response in the Study of Oxytocin in Autism to Improve Reciprocal Social Behaviors.","authors":"Alyssa Verdes, Suvekcha Bhattachan, Alexander Kolevzon, Bryan H King, Christopher J McDougle, Kevin B Sanders, Soo-Jeong Kim, Marina Spanos, Tara Chandrasekhar, Carol Rockhill, Michelle Palumbo, Mendy Minjarez, Lisa Nowinski, Sarah Marler, Stephen Siecinski, Stephanie Giamberardino, Simon G Gregory, Jeremy Veenstra-VanderWeele, Linmarie Sikich, Amandeep Jutla","doi":"10.1089/cap.2024.0131","DOIUrl":"https://doi.org/10.1089/cap.2024.0131","url":null,"abstract":"<p><p><b><i>Background:</i></b> Although randomized clinical trials (RCTs) have investigated several treatments for social communication difficulties and repetitive behavior in autism, none has yet shown consistent superiority over placebo. Placebo response in autism RCTs may impede the ability to detect meaningful treatment effects. <b><i>Objective:</i></b> We sought to identify individual-level predictors of placebo response in Study of Oxytocin in Autism to improve Reciprocal Social Behaviors (SOARS-B), a 24-week RCT of intranasal oxytocin for social impairment in autistic youth. In our primary analysis, we examined predictors of change in the Aberrant Behavior Checklist-modified Social Withdrawal (ABC-mSW) score at 24 weeks in SOARS-B participants taking placebo. Secondary analyses examined predictors of ABC-mSW change at 12 weeks and of Clinical Global Impressions-Improvement at 24 and 12 weeks. We also examined predictors of response among SOARS-B participants taking oxytocin. <b><i>Methods:</i></b> For each analysis, we first used lasso (least absolute shrinkage and selection operator) regression to identify potentially influential predictors from a large group that included demographic factors, rating scale data, and prescribed medications. We then estimated an unpenalized linear regression model for the outcome of interest that included only variables retained by the optimal lasso. We considered variables with statistically significant coefficients to be influential predictors. <b><i>Results:</i></b> Higher baseline ABC-mSW score was the only significant predictor of greater ABC-mSW change in the placebo group at 24 and 12 weeks. <b><i>Conclusions:</i></b> In SOARS-B, higher baseline severity on a measure of reciprocal social communication predicted greater placebo response. This is consistent with the finding that lower social communication adaptive functioning was associated with greater placebo response in recent RCTs of balovaptan for social impairment in autism. However, it contrasts with findings from a trial of citalopram for repetitive behavior in autism, in which lower baseline severity of a composite of autistic and mood symptoms predicted greater placebo response. This may indicate that different factors contribute to placebo response in different symptom domains.</p>","PeriodicalId":15277,"journal":{"name":"Journal of child and adolescent psychopharmacology","volume":" ","pages":""},"PeriodicalIF":1.5,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143458156","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}
引用次数: 0
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