[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Otsuka Pharmaceutical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":245},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,38,61,84,102,126,145,166,187,204,223],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":26,"lastUpdatePostDateStruct":27,"startDateStruct":30,"completionDateStruct":32,"leadSponsor":34,"locationsCount":37},"100465574","specified-drug-use-survey-on-ajovy-subcutaneous-injection-for-long-term-use-100465574",false,"NCT05342493","Specified Drug Use Survey on AJOVY Subcutaneous Injection for Long-term Use","AJOVY Subcutaneous Injection Long-term Specified Use-results Survey","Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n* patients with a known hypersensitivity to components of AJOVY","ALL","18 Years",{"count":19,"type":20},1000,"ESTIMATED","OBSERVATIONAL","To evaluate the long-term safety of AJOVY in patients under actual use conditions and to specifically evaluate cardiovascular events. In addition, information on efficacy will be collected.",[24],"Migraine Disorders","RECRUITING","2026-06-17",{"date":28,"type":29},"2026-06-22","ACTUAL",{"date":31,"type":29},"2022-04-20",{"date":33,"type":20},"2029-06-22",{"name":35,"class":36},"Otsuka Pharmaceutical Co., Ltd.","INDUSTRY",1,{"id":39,"slug":40,"hasResults":11,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":4,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":45,"targetDuration":4,"studyType":47,"phases":48,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":37},"100610294","phase-3-a-long-term-administration-trial-of-sep-363856-in-patients-with-schizophrenia-100610294","NCT07225712","A Long-term Administration Trial of SEP-363856 in Patients With Schizophrenia","A Multicenter, Uncontrolled, Open-label Trial to Evaluate the Tolerability, Safety, and Efficacy of Long-term Administration of SEP-363856 in Patients With Schizophrenia","Inclusion Criteria:\n\n* Japanese male or female participants 18 years of age or older at the time of informed consent\n* Diagnosed with schizophrenia according to the DSM-5®\n* Judged by the investigator to be clinically stable for at least 8 weeks prior to screening\n* PANSS total score of 80 or less and CGI-S score 4 or less at both screening and baseline\n* No changes in antipsychotic medication for at least 6 weeks before screening (excluding minor dose adjustments for tolerability)\n\nExclusion Criteria:\n\n* History of psychiatric hospitalization within 8 weeks prior to screening\n* Treatment-resistant to antipsychotic therapy (ie, within 1 year to screening, despite administration of two or more marketed antipsychotics at appropriate doses for at least 4 weeks \\[28 consecutive days\\] in accordance with the package insert, psychiatric symptoms did not improve)\n* History of treatment with clozapine\n* Unwillingness, before or during the trial period, to comply with the requirements for prior and concomitant medications\u002Ftherapies as specified in the protocol or use of prohibited medications at screening or baseline as specified in the protocol.",{"count":46,"type":20},100,"INTERVENTIONAL",[49],"PHASE3","To evaluate the safety of SEP-363856 (75 mg\u002Fday or 100 mg\u002Fday) administered for 52 weeks in adult participants with schizophrenia",[52],"Schizophrenia","2026-01-13",{"date":55,"type":29},"2026-01-14",{"date":57,"type":29},"2025-12-22",{"date":59,"type":20},"2028-03",{"name":35,"class":36},{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":4,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":16,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":4,"studyType":47,"phases":72,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":37},"100599656","phase-3-a-long-term-trial-of-eb-1020-in-pediatric-patients-with-adhd-100599656","NCT07087327","A Long-term Trial of EB-1020 in Pediatric Patients With ADHD","A Phase 3, Multicenter, Open-label, Uncontrolled, Long-term Japan-China Joint Trial to Evaluate the Safety and Efficacy of EB-1020 QD XR Capsules Administered Orally Once Daily in Children and Adolescents With Attention- Deficit\u002FHyperactivity Disorder","Inclusion Criteria:\n\n\\\u003CRollover participants\\>\n\n* Participants who completed the 6-week treatment period and 1-week follow-up period in the preceding double-blind parent trial and did not meet the criteria for discontinuation of the IMP at Week 6.\n* Participants who have not been found to have major problems with trial requirements, such as compliance with the IMP, in the preceding double-blind parent trial.\n\n\\\u003CDe novo participants\\>\n\n* Participants with a primary diagnosis of ADHD based on DSM-5 diagnostic criteria, differentiated from other mental disorders using the MINI-KID, excluding other specified ADHD or unspecified ADHD.\n* Participants with a symptom total raw score of \\>= 28 on the ADHD-RS-5 at baseline.\n* Participants with a score of 4 or higher on the Clinical Global Impression Severity - ADHD (CGI-S-ADHD) at baseline.\n\nExclusion Criteria:\n\n\\\u003CRollover participants\\>\n\n* Participants who have a positive pregnancy test result at baseline.\n* Participants who were found to have serious or severe adverse events that were judged to be related to the IMP in the preceding double-blind parent trial.\n* Participants who have a significant risk of committing suicide in the opinion of the investigator or subinvestigator, or based on the following evidence.\n\n  * Active suicidal ideation as evidenced by an answer of \"yes\" on Questions 4 or 5 on the section of suicidal ideation or reported suicidal behavior on the since last visit version of the Columbia-Suicide Severity Rating Scale (C SSRS) in the preceding double-blind parent trial.\n* Participants who plan to use prohibited medication during the trial. Participants who used prohibited medication during the preceding double-blind parent trial should be excluded if the investigator or subinvestigator judges that there is a possibility of repeated use of prohibited medication.\n\n\\\u003CDe novo participants\\>\n\n* Participants who have a positive pregnancy test result at baseline.\n* Participants determined to have the following diseases based on an interview using the MINI-KID.\n\n  * Tourette's disorder\n  * Panic disorder\n  * Conduct disorder\n  * Psychotic disorder\n  * Post-traumatic stress disorder\n  * Bipolar disorder\n* Participants with a generalized anxiety disorder requiring pharmacotherapy, based on the DSM-5 diagnostic criteria.\n* Participants with an autism spectrum disorder based on the DSM-5 diagnostic criteria.\n* Participants with a personality disorder, oppositional defiant disorder, or obsessive-compulsive disorder that is the primary focus of treatment, based on the DSM-5 diagnostic criteria.\n* Participants with a diagnosis of major depressive disorder (MDD), based on the DSM-5 diagnostic criteria who currently have a major depressive episode, or who have required treatment for MDD within the past 3 months prior to screening. Also, participants who, in the judgment of the investigator or subinvestigator, may have a worsening of MDD during the trial or may require treatment during the trial period.\n* Participants who have a diagnosis of intellectual disability with an intelligence quotient (IQ) score less than 70.\n* Participants who have a significant risk of committing suicide in the opinion of the investigator or subinvestigator, or based on the following evidence.\n\n  * Active suicidal ideation as evidenced by an answer of \"yes\" on Questions 4 or 5 (over the last 6 months) on the section of suicidal ideation or a history of suicidal behavior (over the last 6 months) on the Baseline\u002FScreening version of the C-SSRS at screening.\n* Participants with a diagnosis of substance use disorder.\n* Participants who have laboratory test results at screening as follows:\n\n  * Platelets\\\u003C=130,000\u002Fmm3\n  * Hemoglobin\\\u003C=11.2 g\u002FdL\n  * Neutrophils, absolute\\\u003C=1000\u002Fmm3\n  * AST \\> 2 x ULN\n  * ALT \\> 2 x ULN\n  * eGFR \\\u003C 45 mL\u002Fmin\u002F1.73 m2, calculated by the CKiD U25 equation\n  * CPK\\>=2 x ULN (except for the participants that the medical monitor determines that inclusion is possible based on discussion about their condition with the investigator or subinvestigator)\n  * Abnormal values for both free T4 and TSH\n* Participants who cannot agree to discontinuation of prohibited concomitant medication, such as ADHD medication or antidepressants.","6 Years","17 Years",{"count":71,"type":20},180,[49],"The purpose of this study is to evaluate the safety of long-term administration of mainly high doses of EB-1020 over 52 weeks in pediatric ADHD patients.",[75],"Attention-Deficit Hyperactivity Disorder(ADHD)","2025-12-16",{"date":78,"type":29},"2025-12-23",{"date":80,"type":29},"2025-09-16",{"date":82,"type":20},"2027-08",{"name":35,"class":36},{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":68,"maxAge":69,"enrollmentInfo":91,"targetDuration":4,"studyType":47,"phases":93,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":97,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":101,"locationsCount":37},"100599578","phase-2-a-trial-to-evaluate-the-efficacy-and-safety-of-eb-1020-in-pediatric-patients-with-adhd-100599578","NCT07086313","A Trial to Evaluate the Efficacy and Safety of EB-1020 in Pediatric Patients With ADHD","A Phase 2\u002F3, Multicenter, Randomized, Double-blind, Placebo-controlled, Japan-China Joint Trial to Evaluate the Efficacy and Safety of Two Dose Levels of EB-1020 QD XR Capsules Administered Orally Once Daily in Children and Adolescents With Attention-deficit\u002FHyperactivity Disorder","Inclusion Criteria:\n\n* Participants with a primary diagnosis of ADHD based on DSM-5 diagnostic criteria, differentiated from other mental disorders using the MINI-KID, excluding other specified ADHD or unspecified ADHD.\n* Participants with a symptom total raw score of\\>=28 (if not receiving any pharmacological treatment for ADHD) or\\>=22 (if receiving pharmacological treatment for ADHD) on the ADHD Rating Scale Version 5 (ADHD-RS-5) at screening.\n* Participants with a symptom total raw score of\\>=28 on the ADHD-RS-5 at baseline.\n* Participants with a score of 4 or higher on the Clinical Global Impression Severity - ADHD (CGI-S-ADHD) at baseline.\n\nExclusion Criteria:\n\n* Participants who have a positive pregnancy test result at baseline.\n* Participants determined to have the following diseases based on an interview using the MINI-KID.\n\n  * Tourette's disorder\n  * Panic disorder\n  * Conduct disorder\n  * Psychotic disorder\n  * Post-traumatic stress disorder\n  * Bipolar disorder\n* Participants with a generalized anxiety disorder requiring pharmacotherapy, based on the DSM-5 diagnostic criteria.\n* Participants with an autism spectrum disorder based on the DSM-5 diagnostic criteria.\n* Participants with a personality disorder, oppositional defiant disorder, or obsessive-compulsive disorder that is the primary focus of treatment, based on the DSM-5 diagnostic criteria.\n* Participants with a diagnosis of major depressive disorder (MDD), based on the DSM-5 diagnostic criteria who currently have a major depressive episode, or who have required treatment for MDD within the past 3 months prior to screening.\n\nAlso, participants who, in the judgment of the investigator or subinvestigator, may have a worsening of MDD during the trial or may require treatment during the trial period.\n\n* Participants who have a diagnosis of intellectual disability with an intelligence quotient (IQ) score less than 70.\n* Participants who have a significant risk of committing suicide in the opinion of the investigator or subinvestigator, or based on the following evidence.\n\n  * Active suicidal ideation as evidenced by an answer of \"yes\" on Questions 4 or 5 (over the last 6 months) on the section of suicidal ideation or a history of suicidal behavior (over the last 6 months) on the Baseline\u002FScreening version of the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening.\n* Participants with a diagnosis of substance use disorder.\n\n  * Platelets \\\u003C= 130,000\u002Fmm3\n  * Hemoglobin \\\u003C= 11.2 g\u002FdL\n  * Neutrophils, absolute \\\u003C= 1000\u002Fmm3\n  * AST \\> 2 x ULN\n  * ALT \\> 2 x ULN\n  * eGFR \\\u003C 45 mL\u002Fmin\u002F1.73 m2, calculated by the CKiD U25 equation\n  * CPK \\>= 2 x ULN (except for the cases that the medical monitor determined that participant's inclusion is possible based on the discussion about the participant's condition with the investigator or subinvestigator)\n  * Abnormal values for both free T4 and TSH\n* Participants who cannot agree to discontinuation of prohibited concomitant medication, such as ADHD medication or antidepressants.",{"count":92,"type":20},315,[94,49],"PHASE2","The purpose of this study is to evaluate the efficacy and examine the safety of two doses of EB-1020 QD XR capsule administered once daily orally in pediatric ADHD patients.",[75],{"date":78,"type":29},{"date":99,"type":29},"2025-09-03",{"date":82,"type":20},{"name":35,"class":36},{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":109,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":47,"phases":113,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":37},"100607137","phase-3-a-phase-3-trial-of-opa-15406-foam-in-children-and-infants-with-atopic-dermatitis-100607137","NCT07184645","A Phase 3 Trial of OPA-15406 Foam in Children and Infants With Atopic Dermatitis","A Multicenter, Randomized, Double-blind, Vehicle-controlled, Parallel-group Comparison Trial to Demonstrate the Superiority of 0.3% OPA-15406 Foam to the Vehicle in Children With Atopic Dermatitis in Combination With an Open-label, Uncontrolled Trial to Evaluate the Safety and Efficacy of 0.3% and 1% OPA-15406 Foam in Infants Under 2 Years of Age and Children With Atopic Dermatitis (Phase 3 Trial)","Inclusion Criteria:\n\n* Participants who have been diagnosed with AD based on the Diagnostic Criteria for Atopic Dermatitis (Criteria of the Japanese Dermatological Association)\n* Participants who have an affected area covering from 5% to 40% of their body surface area (excluding the scalp) at the screening and baseline examinations\n* Participants with an IGA score of 2 or 3 at the screening and baseline examinations\n\nExclusion Criteria:\n\n* Participants who experienced an acute exacerbation of AD or contact dermatitis within 28 days prior to the baseline examination\n* Participants who have been treated with OPA-15406 ointment in the past","3 Months","14 Years",{"count":112,"type":20},198,[49],"To investigate the superiority of 0.3% OPA-15406 foam to the vehicle in children with atopic dermatitis (AD)",[116],"Atopic Dermatitis (AD)","NOT_YET_RECRUITING","2025-09-18",{"date":120,"type":29},"2025-09-22",{"date":122,"type":20},"2025-09",{"date":124,"type":20},"2027-02",{"name":35,"class":36},{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":132,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":37},"100597084","lupkynis-drug-use-results-survey-100597084","NCT07053891","LUPKYNIS Drug-use Results Survey","Inclusion Criteria:\n\n* Patients who are newly starting administration of LUPKYNIS for lupus nephritis\n\nExclusion Criteria:\n\n\\-","15 Years",{"count":134,"type":20},400,"The purpose of this study is to survey the safety of LUPKYNIS in patients with lupus nephritis under actual use conditions. In addition, information on efficacy will be collected.",[137],"Lupus Nephritis",{"date":139,"type":29},"2025-09-19",{"date":141,"type":29},"2025-09-17",{"date":143,"type":20},"2032-06-30",{"name":35,"class":36},{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":16,"minAge":132,"maxAge":152,"enrollmentInfo":153,"targetDuration":4,"studyType":47,"phases":155,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":37},"100606278","phase-3-a-phase-3-trial-to-demonstrate-the-superiority-of-1-opa-15406-foam-to-the-vehicle-in-adult-patients-with-atopic-dermatitis-100606278","NCT07173478","A Phase 3 Trial to Demonstrate the Superiority of 1% OPA-15406 Foam to the Vehicle in Adult Patients With Atopic Dermatitis","A Multicenter, Randomized, Double-blind, Vehicle-controlled, Parallel-group Comparison Trial to Demonstrate the Superiority of 1% OPA-15406 Foam to the Vehicle in Adult Patients With Atopic Dermatitis (Phase 3 Trial)","Inclusion Criteria:\n\n* Participants who have been diagnosed AD based on the Diagnostic Criteria for Atopic Dermatitis (Criteria of the Japanese Dermatological Association)\n* Participants with a history of AD for at least 3 years\n* Participants who have an affected area covering from 5% to 40% of their body surface area (excluding the scalp) at the screening and baseline examinations\n* Participants with an IGA score of 2 or 3 at the screening and baseline examinations\n\nExclusion Criteria:\n\n* Participants who experienced an acute exacerbation of AD or contact dermatitis within 28 days prior to the baseline examination\n* Participants who have been treated with OPA-15406 ointment in the past","70 Years",{"count":154,"type":20},156,[49],"To investigate the superiority of 1% OPA-15406 foam to the vehicle in adult patients with atopic dermatitis (AD).",[116],"2025-09-07",{"date":160,"type":29},"2025-09-15",{"date":162,"type":20},"2025-10",{"date":164,"type":20},"2026-12",{"name":35,"class":36},{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":173,"enrollmentInfo":174,"targetDuration":4,"studyType":47,"phases":175,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":37},"100587318","phase-3-a-long-term-trial-of-eb-1020-in-adult-patients-with-adhd-100587318","NCT06926829","A Long-term Trial of EB-1020 in Adult Patients With ADHD","A Phase 3, Multicenter, Open-label, Uncontrolled, Long-term Trial to Evaluate the Safety and Efficacy of Long-term Administration of EB-1020 Once Daily QD XR Capsules in Adults With Attention-deficit\u002FHyperactivity Disorder","Inclusion Criteria:\n\n* Participants who completed the treatment period andfollow-up period in the preceding double-blind parent Trial (Trial 405-102-00112) and did not meet the criteria for discontinuation of the investigational medicinal product (IMP).\n* Participants who have not been found to have major problems with trial requirements, such as compliance with the IMP, in the preceding double-blind parent trial.\n\nExclusion Criteria:\n\n* Participants who are pregnant or breastfeeding or test positive for pregnancy on baseline visit.\n* Participants who started prohibited concomitant medications\u002Ftherapies for ADHD or other comorbidities at the end of the follow-up period of the preceding trial, or participants for whom starting treatment is deemed beneficial.\n* Participants who have a significant risk of committing suicide in the opinion of the investigator or subinvestigator, or based on the following evidence:\n\n  * Active suicidal ideation as evidenced by an answer of \"yes\" on Questions 4 or 5 on the section of suicidal ideation on the since last visit version of the Columbia-Suicide Severity Rating Scale (C-SSRS) in the preceding double-blind parent trial or\n  * Reported suicidal behavior\n* Participants who were found to have serious or severe adverse events that were judged to be related to the IMP in the preceding double-blind parent trial.\n* Participants who test positive for drugs or alcohol in a urine test on baseline visit.","55 Years",{"count":71,"type":20},[49],"The purpose of this study is to evaluate the safety of long-term administration of mainly high doses of EB-1020 over 52 weeks in patients who have completed the double-blind trial (405-102-00112) conducted in Japan",[178],"Attention Deficit Hyperactivity Disorder (ADHD)","2025-07-30",{"date":181,"type":29},"2025-08-03",{"date":183,"type":29},"2025-06-25",{"date":185,"type":20},"2027-12",{"name":35,"class":36},{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":173,"enrollmentInfo":194,"targetDuration":4,"studyType":47,"phases":196,"briefSummary":197,"conditions":198,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":199,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":203,"locationsCount":37},"100587645","phase-2-evaluation-of-the-efficacy-and-safety-of-eb-1020-in-adult-adhd-patients-100587645","NCT06931080","Evaluation of the Efficacy and Safety of EB-1020 in Adult ADHD Patients","A Phase 2\u002F3, Multicenter, Randomized, Double-blind, Placebo-controlled, Trial to Evaluate the Efficacy and Safety of EB-1020 Once Daily QD XR Capsules Administered Orally at Low or High Dose in Adults With Attention-deficit\u002FHyperactivity Disorder","Inclusion Criteria:\n\n* Participants diagnosed primarily with ADHD (excluding other specified or unspecified attention-deficit\u002Fhyperactivity disorder) according to DSM-5 criteria, based on information collected through interviews using the Japanese version of the Conners' Adult ADHD Diagnostic Interview for DSM-IVTM (CAADID).\n* Participants with an AISRS total score meeting the following criteria:\n\n  * Not receiving medication treatment for ADHD: 28 points or higher\n  * Receiving medication treatment for ADHD: 22 points or higher\n\nExclusion Criteria:\n\n* Participants who are pregnant or breastfeeding, and those who test positive for pregnancy at screening.\n* Participants have a current comorbid psychiatric disorder that either could be expected to require treatment with medications prohibited in this trial, or to confound efficacy or safety assessments. Examples include, but are not limited to, psychotic disorder (current or lifetime), bipolar disorder (current or lifetime), generalized anxiety disorder, obsessive-compulsive disorder, panic disorder, a current major depressive episode, or posttraumatic stress disorder, as established by the MINI.\n* Participants diagnosed with a personality disorder according to DSM-5 criteria.\n* Participants diagnosed with autism spectrum disorder according to DSM-5 criteria.\n* Participants diagnosed with intellectual disability and an IQ score below 70.\n* Participants who, in the judgment of the principal or sub-investigator, or based on the following criteria, are at significant risk of suicide:\n\n  • Clear suicidal ideation or a history of suicidal behavior (within the past 6 months) as indicated by a \"\"yes\"\" answer to questions 4 or 5 in the suicidal ideation section of the C-SSRS Baseline\u002FScreening version at screening.\n* Participants who have a current or past episode of substance-related disorders (excluding tobacco-related disorders) according to DSM-5 diagnostic criteria.\n* Participants diagnosed with eating disorders and feeding disorders according to DSM-5 diagnostic criteria.\n* Participants who show a positive reaction in alcohol tests or urine drug tests at screening.\n* Participants with complications or a history of the following neurological disorders:\n\n  * Epilepsy\n  * Seizures (other than infantile febrile seizures)\n  * Syncope\n  * Tourette's disorder\n  * History of significant head trauma with clinically significant loss of consciousness\n  * Dementia\n  * Cerebrovascular disease\n  * Parkinson's disease\n  * Intracranial lesions\n  * Other severe neurological disorders\n* Participants with complications or a history of cardiovascular diseases.\n* Participants with clinical laboratory test results at screening that meet any of the following criteria:\n\n  * Platelets \\\u003C= 75,000\u002Fmm3\n  * Hemoglobin \\\u003C= 9 g\u002FdL\n  * Neutrophils, absolute \\\u003C= 1000\u002Fmm3\n  * AST \\> 2 x ULN\n  * ALT \\> 2 x ULN\n  * Creatinine \\>= 2 mg\u002FdL\n  * CPK \\>= 2 x ULN (except for the cases that the medical monitor determined that participant's inclusion is possible based on the discussion about the participant's condition with the investigator or subinvestigator) •Abnormal values for both free T4 and TSH•\n* Participants who cannot agree to discontinuation of prohibited concomitant medication, such as ADHD medication or antidepressants.",{"count":195,"type":20},630,[94,49],"The purpose of this study is to evaluate the efficacy and examine the safety of two doses of EB-1020 QD XR capsule administered once daily orally in adult ADHD patients.",[178],{"date":181,"type":29},{"date":201,"type":29},"2025-04-30",{"date":185,"type":20},{"name":35,"class":36},{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":16,"minAge":132,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":212,"conditions":213,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":37},"100583412","rexulti-drug-general-use-results-survey-excessive-motor-activity-or-physicallyverbally-aggressive-behavior-due-to-rapid-changes-in-mood-irritability-andor-outbursts-associated-with-dementia-due-to-alzheimers-disease-100583412","NCT06875986","REXULTI Drug General Use-results Survey (Excessive Motor Activity or Physically\u002FVerbally Aggressive Behavior Due to Rapid Changes in Mood, Irritability, and\u002For Outbursts Associated With Dementia Due to Alzheimer's Disease)","Inclusion Criteria:\n\n* Patients diagnosed with Alzheimer's disease\n\nExclusion Criteria:\n\n\\-",{"count":211,"type":20},200,"The purpose of this study is to evaluate safety of REXULTI in patients under daily clinical settings. In addition, information on efficacy will be collected.",[214],"Alzheimer Disease","2025-06-27",{"date":217,"type":29},"2025-07-02",{"date":219,"type":29},"2025-04-17",{"date":221,"type":20},"2028-09-23",{"name":35,"class":36},{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":230,"enrollmentInfo":231,"targetDuration":4,"studyType":47,"phases":233,"briefSummary":234,"conditions":235,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":37},"100464280","phase-3-trial-of-brexpiprazole-once-weekly-qw-formulation-in-patients-with-acute-schizophrenia-100464280","NCT05325645","Trial of Brexpiprazole Once-weekly (QW) Formulation in Patients With Acute Schizophrenia","A Multicenter, Placebo-controlled, Randomized, Double-blind, Parallel-group Comparison Trial to Investigate the Efficacy and Safety of Brexpiprazole Once-weekly (QW) Formulation in Patients With Acute Schizophrenia","Inclusion Criteria:\n\n* Patients at least 18 years of age and below the age of 65 at the time of informed consent\n* Patients with a diagnosis of schizophrenia based on DSM-5® (295.90) (multiple episodes, currently in acute episode) and confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I.) at the time of informed consent\n* Patients who are hospitalized, or judged to require hospitalization, for acute relapse of schizophrenia at the time of informed consent\n* Patients whose current episode developed within 2 months prior to screening\n* Patients who were treated with antipsychotics at appropriate doses for appropriate durations for the most recent acute episode and who are considered to have responded to the antipsychotics (excluding clozapine)\n* Patients who experienced a recurrence or exacerbation of symptoms during an antipsychotic-free period\n* Patients who have been fully informed of and understand the objectives, procedures, risks, and expected medicinal benefits of the trial and are able to provide written informed consent prior to initiation of any trial-related procedures\n\nExclusion Criteria:\n\n\\\u003CRegarding indication\\>\n\n* Patients presenting a first episode of schizophrenia based on the clinical judgment of the investigator\n* Patients who are considered resistant\u002Frefractory to antipsychotic treatment Patients who are \"unresponsive to medication with 2 or more antipsychotics at effective doses for a sufficiently long duration (6 weeks)\" will be deemed resistant\u002Frefractory to antipsychotic treatment.\n* Patients who have a history of treatment with clozapine for schizophrenia\n* Patients experiencing acute depressive symptoms within 30 days prior to informed consent that, in the judgment of the investigator, require treatment with an antidepressant\n* Patients who fall under any of the following criteria regarding suicidal ideation and suicidal behavior\n\n  * Patients who answered \"yes\" to Question 4 \"Active Suicidal Ideation with Some Intent to Act, without Specific Plan\" or Question 5 \"Active Suicidal Ideation with Specific Plan and Intent\" regarding C-SSRS suicidal ideation at screening (for the past 6 months) or at baseline (since the last assessment)\n  * Patients who exhibited suicidal behavior on C-SSRS at screening (for the past 2 years) or at baseline (since the last assessment)\n  * Patients who present a serious risk of suicide based on the judgment of the investigator\n* Patients presenting tardive dyskinesia at the time of informed consent, as determined by a score of 3 (moderate) or 4 (severe) for Item 8 (severity of abnormal movements) of the AIMS at screening or at baseline\n* Patients with a score of 5 (severe akathisia) in the BARS global clinical assessment of akathisia at screening or at baseline\n* Patients who meet either of the following criteria between 30 days before screening and the start of screening\\*\n\n  * Not including the start date of screening\n\n    1. Received 2 or more antipsychotics, each at doses equivalent to ≥ 600 mg\u002Fday of chlorpromazine\n    2. Received a mean daily dose equivalent to \\> 800 mg\u002Fday\\*\\*,\\*\\*\\* of chlorpromazine\n\n       '\\*\\*If multiple antipsychotics are taken in the same day, this is to be the combined equivalent dose.\n\n       \\*\\*\\*This does not include administration of antipsychotic medication at doses equivalent to less than 100 mg\u002Fday of chlorpromazine, which are not expected to have any antipsychotic effect. Chlorpromazine equivalent doses are based on Equivalent Conversion Table for Antipsychotics, as specified separately.\n* Patients with a diagnosis of a concurrent mental disorder besides schizophrenia (schizoaffective disorder, major depressive disorder, bipolar I disorder, bipolar II disorder, general anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, dementia or mild neurocognitive disorder, personality disorder, etc) based on DSM-5®. However, this exclusion does not apply to the following:\n\n  • Caffeine- or tobacco-related disorders\n* Patients who have met the DSM-5® diagnostic criteria for substance-related or addictive disorder, including alcohol and benzodiazepines but excluding caffeine and tobacco, within 180 days before commencement of investigational medicinal product (IMP) administration\n* Patients who have a clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorder. Medical conditions that are minor or well-controlled may be considered acceptable if the condition does not interfere with safety and efficacy assessments.\n* Patients with known hypersensitivity or intolerance to brexpiprazole or patients with confirmed resistance to brexpiprazole therapy. Patients who have received brexpiprazole to treat the current episode.\n* Patients judged by the investigator to be unsuitable for participation in the trial.","64 Years",{"count":232,"type":20},450,[49],"Confirm the efficacy of the brexpiprazole QW formulation versus placebo for acute symptoms of schizophrenia",[236],"Acute Schizophrenia","2025-03-10",{"date":239,"type":29},"2025-03-12",{"date":241,"type":29},"2022-07-21",{"date":243,"type":20},"2026-03",{"name":35,"class":36},""]