Psychiatry and Clinical Neurosciences最新文献

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Cognitive dysfunction in psychiatric disorders: Well-known but narrowly explored. 精神病患者的认知功能障碍:众所周知,但研究范围狭窄。
IF 5 3区 医学
Psychiatry and Clinical Neurosciences Pub Date : 2024-11-01 DOI: 10.1111/pcn.13749
Shinsuke Koike
{"title":"Cognitive dysfunction in psychiatric disorders: Well-known but narrowly explored.","authors":"Shinsuke Koike","doi":"10.1111/pcn.13749","DOIUrl":"https://doi.org/10.1111/pcn.13749","url":null,"abstract":"","PeriodicalId":20938,"journal":{"name":"Psychiatry and Clinical Neurosciences","volume":"78 11","pages":"631-632"},"PeriodicalIF":5.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142569268","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Initial treatment choices for long-term remission of chronic insomnia disorder in adults: a systematic review and network meta-analysis. 成人慢性失眠症长期缓解的初始治疗选择:系统综述和网络荟萃分析。
IF 5 3区 医学
Psychiatry and Clinical Neurosciences Pub Date : 2024-11-01 Epub Date: 2024-08-26 DOI: 10.1111/pcn.13730
Yuki Furukawa, Masatsugu Sakata, Toshiaki A Furukawa, Orestis Efthimiou, Michael Perlis
{"title":"Initial treatment choices for long-term remission of chronic insomnia disorder in adults: a systematic review and network meta-analysis.","authors":"Yuki Furukawa, Masatsugu Sakata, Toshiaki A Furukawa, Orestis Efthimiou, Michael Perlis","doi":"10.1111/pcn.13730","DOIUrl":"10.1111/pcn.13730","url":null,"abstract":"<p><strong>Background: </strong>We aimed to evaluate the comparative efficacy and acceptability of cognitive behavioral therapy for insomnia (CBT-I), pharmacotherapy, and their combination in the long and short terms among adults with chronic insomnia disorder.</p><p><strong>Methods: </strong>We searched multiple databases to December 27, 2023. We included trials in hypnotic-free adults with chronic insomnia comparing at least two of CBT-I, pharmacotherapy, or their combination. We assessed the confidence in evidence using CINeMA. The primary outcome was long-term remission. Secondary outcomes included all-cause dropout and self-reported sleep continuity measures in the long term, and the same outcomes in the short term. We performed frequentist random-effects network meta-analyses (CRD42024505519).</p><p><strong>Findings: </strong>We identified 13 trials including 823 randomized participants (mean age, 47.8 years; 60% women). CBT-I was more beneficial than pharmacotherapy in the long term (median duration, 24 weeks [range, 12 to 48 weeks]; remission odds ratio, 1.82 [95% confidence interval (CI), 1.15-2.87]; [certainty of evidence: high]), while there was weaker evidence of benefit of combination against pharmacotherapy (1.71 [95% CI, 0.88-3.30: moderate]) and no clear difference of CBT-I against combination (1.07 [95% CI, 0.63-1.80: moderate]). CBT-I was associated with fewer dropouts than pharmacotherapy. Short-term outcomes favored CBT-I over pharmacotherapy except total sleep time. Given the average long-term remission rate in the pharmacotherapy-initiating arms of 28%, CBT-I resulted in a long-term remission rate of 41% (95% CI, 31%-53%) and combination 40% (95% CI, 25%-56%).</p><p><strong>Interpretation: </strong>The current study found that starting with CBT-I for chronic insomnia leads to better outcomes than pharmacotherapy. Combination may be better than pharmacotherapy alone, but unlikely to be worth the additional burden over CBT-I alone.</p>","PeriodicalId":20938,"journal":{"name":"Psychiatry and Clinical Neurosciences","volume":" ","pages":"646-653"},"PeriodicalIF":5.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142073753","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Sleep and circadian rhythm as digital biomarkers in bipolar disorder. 睡眠和昼夜节律作为双相情感障碍的数字生物标记。
IF 5 3区 医学
Psychiatry and Clinical Neurosciences Pub Date : 2024-11-01 DOI: 10.1111/pcn.13739
Yoshikazu Takaesu
{"title":"Sleep and circadian rhythm as digital biomarkers in bipolar disorder.","authors":"Yoshikazu Takaesu","doi":"10.1111/pcn.13739","DOIUrl":"https://doi.org/10.1111/pcn.13739","url":null,"abstract":"","PeriodicalId":20938,"journal":{"name":"Psychiatry and Clinical Neurosciences","volume":"78 11","pages":"629"},"PeriodicalIF":5.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142569276","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Risk of subsequent Parkinson's disease among patients with bipolar disorder or major depression: A nationwide longitudinal study in Taiwan. 双相情感障碍或重度抑郁症患者罹患帕金森病的风险:台湾一项全国性纵向研究。
IF 5 3区 医学
Psychiatry and Clinical Neurosciences Pub Date : 2024-11-01 DOI: 10.1111/pcn.13759
Mao-Hsuan Huang, Chih-Ming Cheng, Ju-Wei Hsu, Ya-Mei Bai, Tung-Ping Su, Cheng-Ta Li, Shih-Jen Tsai, Yee-Lam E Chan, Mu-Hong Chen
{"title":"Risk of subsequent Parkinson's disease among patients with bipolar disorder or major depression: A nationwide longitudinal study in Taiwan.","authors":"Mao-Hsuan Huang, Chih-Ming Cheng, Ju-Wei Hsu, Ya-Mei Bai, Tung-Ping Su, Cheng-Ta Li, Shih-Jen Tsai, Yee-Lam E Chan, Mu-Hong Chen","doi":"10.1111/pcn.13759","DOIUrl":"https://doi.org/10.1111/pcn.13759","url":null,"abstract":"<p><strong>Aim: </strong>Bipolar disorder (BD) and major depression have been associated with an increased risk of developing Parkinson's disease (PD); however, few studies have directly compared the risk of PD development between patients with BD and major depression while considering relevant risk factors and psychotropic medications.</p><p><strong>Methods: </strong>Using the Taiwan National Health Insurance Research Database, 21,186 patients with BD, 21,188 patients with major depression, and 42,374 controls were enrolled between 2001 and 2009, and followed until the end of 2011. Individuals who developed PD during the follow-up period were identified. Cox regression models were used to analyze the hazard ratio (HR) of developing PD, adjusting for demographic factors, comorbidities, and psychotropic medication usage.</p><p><strong>Results: </strong>Both patients with BD [HR 8.63, 95% confidence interval (CI) 6.35-11.72] and those with major depression (HR 5.68, 95% CI 4.15-7.78) had an elevated risk of subsequent PD compared to the controls. Patients with BD were associated with a 51% increased risk of subsequent PD compared with patients with major depression. Long-term treatment with antiepileptic mood stabilizers was associated with increased PD risk among patients with late-onset BD and high Charlson comorbidity index scores. Lithium was not associated with an increased PD risk.</p><p><strong>Conclusions: </strong>The study highlights an elevated PD risk in patients with BD and major depression compared to the controls, with BD patients at highest risk. Further research is needed to elucidate the complex interplay between psychotropic medications and neurodegenerative processes in BD, aiming to optimize therapeutic strategies and improve patient outcomes.</p>","PeriodicalId":20938,"journal":{"name":"Psychiatry and Clinical Neurosciences","volume":" ","pages":""},"PeriodicalIF":5.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142558617","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Practice Guidelines for Bipolar Disorder by the JSMD (Japanese Society of Mood Disorders). 日本情绪障碍协会(JSMD)躁郁症实践指南。
IF 5 3区 医学
Psychiatry and Clinical Neurosciences Pub Date : 2024-11-01 Epub Date: 2024-08-28 DOI: 10.1111/pcn.13724
Tadafumi Kato, Kazuyoshi Ogasawara, Keisuke Motomura, Masaki Kato, Teruaki Tanaka, Yoshikazu Takaesu, Shintaro Nio, Taro Kishi, Mirai So, Kiyotaka Nemoto, Eiji Suzuki, Koichiro Watanabe, Koji Matsuo
{"title":"Practice Guidelines for Bipolar Disorder by the JSMD (Japanese Society of Mood Disorders).","authors":"Tadafumi Kato, Kazuyoshi Ogasawara, Keisuke Motomura, Masaki Kato, Teruaki Tanaka, Yoshikazu Takaesu, Shintaro Nio, Taro Kishi, Mirai So, Kiyotaka Nemoto, Eiji Suzuki, Koichiro Watanabe, Koji Matsuo","doi":"10.1111/pcn.13724","DOIUrl":"10.1111/pcn.13724","url":null,"abstract":"<p><p>The Japanese Society of Mood Disorders (JSMD) published treatment guidelines of bipolar disorder in 2011. The present guidelines incorporating new findings were developed to comply to the guidelines of the National Academy of Medicine (NAM) by utilizing systematic reviews and meta-analysis and taking patient and family opinions as well as insights from multiple professional fields into account. They support combination therapy using mood stabilizers and second-generation antipsychotics in many aspects. They also have limitations, including the grouping of mood stabilizers and second-generation antipsychotics when meta-analysis was performed despite their distinct properties, due to the scarcity of drug-specific evidence. Despite the limitations, these guidelines provide clinical decision support for psychiatrists in Japan.</p>","PeriodicalId":20938,"journal":{"name":"Psychiatry and Clinical Neurosciences","volume":" ","pages":"633-645"},"PeriodicalIF":5.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142081416","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
A double-blind trial of decoded neurofeedback intervention for specific phobias. 针对特定恐惧症的解码神经反馈干预双盲试验。
IF 5 3区 医学
Psychiatry and Clinical Neurosciences Pub Date : 2024-11-01 Epub Date: 2024-09-02 DOI: 10.1111/pcn.13726
Cody A Cushing, Hakwan Lau, Mitsuo Kawato, Michelle G Craske, Vincent Taschereau-Dumouchel
{"title":"A double-blind trial of decoded neurofeedback intervention for specific phobias.","authors":"Cody A Cushing, Hakwan Lau, Mitsuo Kawato, Michelle G Craske, Vincent Taschereau-Dumouchel","doi":"10.1111/pcn.13726","DOIUrl":"10.1111/pcn.13726","url":null,"abstract":"<p><strong>Aim: </strong>A new closed-loop functional magnetic resonance imaging method called multivoxel neuroreinforcement has the potential to alleviate the subjective aversiveness of exposure-based interventions by directly inducing phobic representations in the brain, outside of conscious awareness. The current study seeks to test this method as an intervention for specific phobia.</p><p><strong>Methods: </strong>In a randomized, double-blind, controlled single-university trial, individuals diagnosed with at least two (one target, one control) animal subtype-specific phobias were randomly assigned (1:1:1) to receive one, three, or five sessions of multivoxel neuroreinforcement in which they were rewarded for implicit activation of a target animal representation. Amygdala response to phobic stimuli was assessed by study staff blind to target and control animal assignments. Pretreatment to posttreatment differences were analyzed with a two-way repeated-measures anova.</p><p><strong>Results: </strong>A total of 23 participants (69.6% female) were randomized to receive one (n = 8), three (n = 7), or five (n = 7) sessions of multivoxel neuroreinforcement. Eighteen (n = 6 each group) participants were analyzed for our primary outcome. After neuroreinforcement, we observed an interaction indicating a significant decrease in amygdala response for the target phobia but not the control phobia. No adverse events or dropouts were reported as a result of the intervention.</p><p><strong>Conclusion: </strong>Results suggest that multivoxel neuroreinforcement can specifically reduce threat signatures in specific phobia. Consequently, this intervention may complement conventional psychotherapy approaches with a nondistressing experience for patients seeking treatment. This trial sets the stage for a larger randomized clinical trial to replicate these results and examine the effects on real-life exposure.</p><p><strong>Clinical trial registration: </strong>The now-closed trial was prospectively registered at ClinicalTrials.gov with ID NCT03655262.</p>","PeriodicalId":20938,"journal":{"name":"Psychiatry and Clinical Neurosciences","volume":" ","pages":"678-686"},"PeriodicalIF":5.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11531993/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142111419","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Knowing treatment response without awareness. 在不知不觉中了解治疗反应。
IF 5 3区 医学
Psychiatry and Clinical Neurosciences Pub Date : 2024-11-01 DOI: 10.1111/pcn.13744
Shinsuke Koike
{"title":"Knowing treatment response without awareness.","authors":"Shinsuke Koike","doi":"10.1111/pcn.13744","DOIUrl":"https://doi.org/10.1111/pcn.13744","url":null,"abstract":"","PeriodicalId":20938,"journal":{"name":"Psychiatry and Clinical Neurosciences","volume":"78 11","pages":"630"},"PeriodicalIF":5.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142569272","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Homogenization of word relationships in schizophrenia: Topological analysis of cortical semantic representations. 精神分裂症患者词语关系的同质化:皮层语义表征的拓扑分析。
IF 5 3区 医学
Psychiatry and Clinical Neurosciences Pub Date : 2024-11-01 Epub Date: 2024-08-28 DOI: 10.1111/pcn.13727
Ryusuke Hayashi, Shizuo Kaji, Yukiko Matsumoto, Satoshi Nishida, Shinji Nishimoto, Hidehiko Takahashi
{"title":"Homogenization of word relationships in schizophrenia: Topological analysis of cortical semantic representations.","authors":"Ryusuke Hayashi, Shizuo Kaji, Yukiko Matsumoto, Satoshi Nishida, Shinji Nishimoto, Hidehiko Takahashi","doi":"10.1111/pcn.13727","DOIUrl":"10.1111/pcn.13727","url":null,"abstract":"<p><strong>Aim: </strong>Patients with schizophrenia typically exhibit symptoms of disorganized thought and display concreteness and over-inclusion in verbal reports, depending on the level of abstraction. While concreteness and over-inclusion may appear contradictory, the underlying psychopathology that explains these symptoms remains unclear. In the current study, we used functional magnetic resonance imaging with an encoding modeling approach to examine how concepts of various words, represented as brain activity, are anomalously connected at different levels of abstraction in patients with schizophrenia.</p><p><strong>Methods: </strong>Fourteen individuals diagnosed with schizophrenia and 17 healthy controls underwent functional magnetic resonance imaging to measure brain activity representing concepts of various words. We used a persistent homology (PH) method to analyze the topological structures of word representations in schizophrenia patients, healthy controls, and random data, across different levels of abstraction by varying dissimilarity scales in the representation space.</p><p><strong>Results: </strong>The results revealed that patients with schizophrenia exhibited more homogeneous word relationships across different levels of abstraction compared with healthy controls. Additionally, topological structures exhibited a shift toward a random network structure in patients with schizophrenia compared with controls. The PH method successfully distinguished semantic representations of patients with schizophrenia from those of controls.</p><p><strong>Conclusions: </strong>The current results provide an explanation for the mechanisms underlying the deficits in abstraction ability observed in schizophrenia. The isotopic connection of individual concepts reflects both the reduction of contextual connections at a semantically fine-grained scale and the absence of clear boundaries between related concepts at a coarse scale, which lead to concreteness and over-inclusion, respectively.</p>","PeriodicalId":20938,"journal":{"name":"Psychiatry and Clinical Neurosciences","volume":" ","pages":"687-695"},"PeriodicalIF":5.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142081415","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Rare nonsynonymous germline and mosaic de novo variants in Japanese patients with schizophrenia. 日本精神分裂症患者中罕见的非同义种系变异和镶嵌式从头变异。
IF 5 3区 医学
Psychiatry and Clinical Neurosciences Pub Date : 2024-10-22 DOI: 10.1111/pcn.13758
Yuichiro Watanabe, Masaki Nishioka, Ryo Morikawa, Satoko Takano-Isozaki, Hirofumi Igeta, Kanako Mori, Tadafumi Kato, Toshiyuki Someya
{"title":"Rare nonsynonymous germline and mosaic de novo variants in Japanese patients with schizophrenia.","authors":"Yuichiro Watanabe, Masaki Nishioka, Ryo Morikawa, Satoko Takano-Isozaki, Hirofumi Igeta, Kanako Mori, Tadafumi Kato, Toshiyuki Someya","doi":"10.1111/pcn.13758","DOIUrl":"https://doi.org/10.1111/pcn.13758","url":null,"abstract":"<p><strong>Aim: </strong>Whole-exome sequencing (WES) studies have revealed that germline de novo variants (gDNVs) contribute to the genetic etiology of schizophrenia. However, the contribution of mosaic DNVs (mDNVs) to the risk of schizophrenia remains to be elucidated. In the present study, we systematically investigated the gDNVs and mDMVs that contribute to the genetic etiology of schizophrenia in a Japanese population.</p><p><strong>Methods: </strong>We performed deep WES (depth: 460×) of 73 affected offspring and WES (depth: 116×) of 134 parents from 67 families with schizophrenia. Prioritized rare nonsynonymous gDNV and mDNV candidates were validated using Sanger sequencing and ultra-deep targeted amplicon sequencing (depth: 71,375×), respectively. Subsequently, we performed a Gene Ontology analysis of the gDNVs and mDNVs to obtain biological insights. Lastly, we selected DNVs in known risk genes for psychiatric and neurodevelopmental disorders.</p><p><strong>Results: </strong>We identified 62 gDNVs and 98 mDNVs. The Gene Ontology analysis of mDNVs implicated actin filament and actin cytoskeleton as candidate biological pathways. There were eight DNVs in known risk genes: splice region gDNVs in AKAP11 and CUL1; a frameshift gDNV in SHANK1; a missense gDNV in SRCAP; missense mDNVs in CTNNB1, GRIN2A, and TSC2; and a nonsense mDNV in ZFHX4.</p><p><strong>Conclusion: </strong>Our results suggest the potential contributions of rare nonsynonymous gDNVs and mDNVs to the genetic etiology of schizophrenia. This is the first report of the mDNVs in schizophrenia trios, demonstrating their potential relevance to schizophrenia pathology.</p>","PeriodicalId":20938,"journal":{"name":"Psychiatry and Clinical Neurosciences","volume":" ","pages":""},"PeriodicalIF":5.0,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142506838","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
AST-001 versus placebo for social communication in children with autism spectrum disorder: A randomized clinical trial. AST-001 与安慰剂治疗自闭症谱系障碍儿童的社交沟通:随机临床试验。
IF 5 3区 医学
Psychiatry and Clinical Neurosciences Pub Date : 2024-10-18 DOI: 10.1111/pcn.13757
Hyo-Won Kim, Ji-Hoon Kim, Un Sun Chung, Johanna Inhyang Kim, Se-Hoon Shim, Tae Won Park, Moon-Soo Lee, Jun-Won Hwang, Eun-Jin Park, Su-Kyeong Hwang, Yoo-Sook Joung
{"title":"AST-001 versus placebo for social communication in children with autism spectrum disorder: A randomized clinical trial.","authors":"Hyo-Won Kim, Ji-Hoon Kim, Un Sun Chung, Johanna Inhyang Kim, Se-Hoon Shim, Tae Won Park, Moon-Soo Lee, Jun-Won Hwang, Eun-Jin Park, Su-Kyeong Hwang, Yoo-Sook Joung","doi":"10.1111/pcn.13757","DOIUrl":"https://doi.org/10.1111/pcn.13757","url":null,"abstract":"<p><strong>Aim: </strong>This study examined the efficacy of AST-001 for the core symptoms of autism spectrum disorder (ASD) in children.</p><p><strong>Methods: </strong>This phase 2 clinical trial consisted of a 12-week placebo-controlled main study, a 12-week extension, and a 12-week follow-up in children aged 2 to 11 years with ASD. The participants were randomized in a 1:1:1 ratio to a high-dose, low-dose, or placebo-to-high-dose control group during the main study. The placebo-to-high-dose control group received placebo during the main study and high-dose AST-001 during the extension. The a priori primary outcome was the mean change in the Adaptive Behavior Composite (ABC) score of the Korean Vineland Adaptive Behavior Scales II (K-VABS-II) from baseline to week 12.</p><p><strong>Results: </strong>Among 151 enrolled participants, 144 completed the main study, 140 completed the extension, and 135 completed the follow-up. The mean K-VABS-II ABC score at the 12th week compared with baseline was significantly increased in the high-dose group (P = 0.042) compared with the placebo-to-high-dose control group. The mean CGI-S scores were significantly decreased at the 12th week in the high-dose (P = 0.046) and low-dose (P = 0.017) groups compared with the placebo-to-high-dose control group. During the extension, the K-VABS-II ABC and CGI-S scores of the placebo-to-high-dose control group changed rapidly after administration of high-dose AST-001 and caught up with those of the high-dose group at the 24th week. AST-001 was well tolerated with no safety concern. The most common adverse drug reaction was diarrhea.</p><p><strong>Conclusions: </strong>Our results provide preliminary evidence for the efficacy of AST-001 for the core symptoms of ASD.</p>","PeriodicalId":20938,"journal":{"name":"Psychiatry and Clinical Neurosciences","volume":" ","pages":""},"PeriodicalIF":5.0,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142473346","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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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