[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Peking University Sixth Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":175},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,49,77,102,126,150],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100632017","efficacy-of-bright-light-therapy-on-cognitive-impairment-in-major-depressive-disorder-and-its-neuroimaging-mechanisms-protocol-for-a-randomised-controlled-trial-100632017",false,"NCT07508215","Efficacy of Bright Light Therapy on Cognitive Impairment in Major Depressive Disorder and Its Neuroimaging Mechanisms: Protocol for a Randomised Controlled Trial","The inclusion and exclusion criteria for MDD patients. 1、Inclusion Criteria:\n\n1. MDD diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-Ⅳ), first episode or recurrence, confirmed by an experienced psychiatrist using the Mini International Neuropsychiatric Interview.\n2. Age between 18 and 60 years; and gender no-limited;\n3. The severity of MDD symptoms must be ≥14 scores on the HAMD-17;\n4. With CI currently, defined as a total score of \\\u003C70 on the SC;\n5. A SSRI monotherapy at stable dosages for at least 4 weeks; or medication-free status;\n6. Education level above primary school, able to understand and cooperate in completing the study procedures;\n7. Voluntarily participating in this study and sign the informed consent before enrollment.\n\n2、Exclusion Criteria:\n\n1. Current or past diagnosis of any disorder other than MDD according to DSM-Ⅳ criteria;\n2. The scores on the Young Mania Rating Scale (YMRS) are\\>8;\n3. The participants who have undergone other intervention in addition to SSRIs whinin the past 6 months or now, or who plan to do that in 1 month;\n4. The participants with strong self-blame, self-harm, or suicidal risks (the HAMD-17 suicide item score of ≥3);\n5. The participants with severe physical illnesses, including heart failure, renal failure, severe liver dysfunction, hyperthyroidism, or hypothyroidism; Or a history of severe brain trauma or organic brain pathology (e.g., intracerebral hemorrhage, large-area cerebral infarction, encephalitis, epilepsy), as well as neurological diseases;\n6. The participants with any degree of retinal pathology, including retinal dystrophy, age-related macular degeneration, diabetic retinopathy, cataracts, glaucoma, or other ocular diseases;\n7. The participants with photosensitive conditions, such as systemic lupus erythematosus, porphyria, chronic photodermatitis, solar urticaria, or those currently receiving medications that may increase photosensitivity (e.g., phenothiazines, antimalarials, propranolol, hypericin, stimulants, or chronic treatment with nonsteroidal anti-inflammatory drugs);\n8. Pregnant or lactating women;\n9. The participants with contraindications to MRI, such as the presence of non-MRI-safe metallic implants or claustrophobia;\n10. The participants deem unsuitable for inclusion in this study by the investigator for other reasons.\n\nWithdrawal and Termination Criteria：\n\n1. The participants meet one of the exclusion criteria above after enrollment;\n2. When the participants' treatment regimen need change;\n3. The participants who fail to cooperate or voluntarily withdraw from the study;\n4. Due to severe adverse events, the patients are unable to tolerate phototherapy;\n5. The participants who fail to adhere to the study protocol intervention for three consecutive days or for a cumulative duration exceeding seven days;\n6. Cancellation of the study.\n\nThe inclusion and exclusion criteria for Health controls\n\n1\\. Inclusion criteria\n\n1. Age between 18 and 60 years; and gender no-limited;\n2. Without CI currently, defined as a total score of ≤ 70 on the SC;\n3. Education level above primary school, able to understand and cooperate in completing the study procedures;\n4. Voluntarily participating in this study and sign the informed consent before enrollment.\n\n2.Exclusion criteria\n\n1. Current or past diagnosis of any psychiatric disorders, or history of substance\u002Fdrug abuse or dependence;\n2. Current or past diagnosis of severe somatic diseases, such as heart failure, renal failure, severe liver dysfunction, or hyperthyroidism\u002Fhypothyroidism;\n3. History of severe traumatic brain injury or organic brain lesions;\n4. Pregnant or lactating women;\n5. The participants with contraindications to MRI, such as the presence of non-MRI-safe metallic implants or claustrophobia.\n6. The participants deem unsuitable for inclusion in this study by the investigator for other reasons.",true,"ALL","18 Years","60 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study aims to validate the therapeutic efficacy and safety of bright light therapy (BLT) in ameliorating cognitive impairment (CI) in major depressive disorder (MDD), characterize the functional and structural features of the hippocampus (HPC)-dorsolateral prefrontal cortex (dlPFC) neural circuitry in MDD participants with CI and examine the mediating effect of the HPC-dlPFC neural circuit on CI induced by BLT treatment in MDD participants. MDD participants will be required to only receive selective serotonin reuptake inhibitors (SSRIs) as monotherapy for at least four weeks, or medication-free status before enrollment. Eligible participants will be randomly assigned to the experimental group and the control group. The experimental group will receive the intervention of BLT, and the control group will receive the intervention of dim red light (DRL). The intervention will last for four weeks, 6 days per week, with 40 minutes each day between 7 am and 10 am. The MDD participants will be followed once in the end of each week during the 4-week intervention and in the end of the 4th week after intervention. Demographic information will be collected at baseline; cognitive function will be evaluated at baseline, weeks 2, 4, and 8 after intervention beginning; and other symptoms such as depression, anxiety and sleep were assessed at baseline, weeks 1, 2, 3, 4, and 8 after intervention beginning. Moreover, structural and functional MRI scans will be made at baseline and post-intervention. During the intervention, MDD participants will be required to keep a record of daily light exposure duration and complete the daily sleep diary as well.",[27,28,29,30],"Major Depressive Disorder (MDD)","Neuroimaging","Bright Light Treatment","Cognitive Impairment",[32,28,33,34,30,35],"Major Depressive Disorder","Magnetic Response Imaging","Bright Light Therapy","Randomized Controlled Trial","RECRUITING","2026-06-28",{"date":39,"type":40},"2026-06-30","ACTUAL",{"date":42,"type":40},"2026-02-08",{"date":44,"type":21},"2028-12-31",{"name":46,"class":47},"Peking University Sixth Hospital","OTHER",2,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":15,"sex":16,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":75,"locationsCount":76},"100586279","clinical-efficacy-safety-and-applicability-of-home-based-bright-light-therapy-in-outpatient-adolescents-with-major-depressive-disorder-100586279","NCT06913309","Clinical Efficacy, Safety, and Applicability of Home-based Bright Light Therapy in Outpatient Adolescents With Major Depressive Disorder","Clinical Efficacy, Safety, and Applicability of Home-based Bright Light Therapy in Outpatient Adolescents With Major Depressive Disorder in China: a Randomised Controlled Trial","The inclusion and exclusion criteria for MDD patients：\n\n1. inclusion criteria\n\n   * Meeting DSM-IV diagnostic criteria for a major depressive episode (first-episode or recurrent) , confirmed by two experienced, independent psychiatrists using the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-Kid);\n   * Aged 13-17 years ;\n   * Medication-naïve or on a stable pharmacological regimen for ≥1 week prior to enrollment;\n   * Baseline Hamilton Depression Rating Scale-17 (HAMD-17) score ≥14;\n   * Minimum of 5 years of formal education, with the ability to complete clinical assessments and comprehend study-related information;\n   * Voluntary participation with written informed consent provided by both participants and their legal guardians.\n2. exclusion criteria\n\n   * Current or past diagnosis of psychiatric disorders other than anxiety or sleep disorders;\n   * History of substance abuse or dependence history (including alcohol, nicotine, or illicit drugs);\n   * Baseline Young Mania Rating Scale (YMRS) total score ≥6;\n   * Received or planned to initiate non-pharmacological systemic interventions within 6 months prior to enrollment or within 1 month after enrollment, including but not limited to: structured psychotherapy (≥1 session\u002Fmonth for \\>6 months), physical therapy (e.g., modified electroconvulsive therapy \\[MECT\\], repetitive transcranial magnetic stimulation \\[rTMS\\], transcranial direct current stimulation \\[tDCS\\], or deep brain stimulation \\[DBS\\]), or exercise therapy ;\n   * Clinician-assessed suicide risk or a HAMD-17 item 3 score ≥3 at the baseline;\n   * Presence of severe systemic or neurological conditions, such as diabetes, hypertension, renal failure, hepatic dysfunction, thyroid disorders, encephalitis, traumatic brain injury, or epilepsy;\n   * Severe retinal pathologies (e.g., retinal detachment, optic atrophy, macular degeneration); or having high myopia (spherical equivalent ≤ -6.00 diopters);\n   * Current use of photosensitizing agents or medications (e.g., chlorpromazine, hypericum extract);\n   * Any other condition deemed inappropriate by the investigators(e.g., cases involving severe sleep phase delays that make morning therapy impossible, or unrecorded photosensitivity).\n\nThe inclusion and exclusion criteria for Health controls\n\n1. Inclusion criteria\n\n   * Aged 13-17 years and right-handed;\n   * Minimum of 5 years of formal education, with the ability to complete clinical assessments and comprehend study-related information;\n   * Voluntary participation with written informed consent provided by both participants and their legal guardians.\n2. Exclusion criteria\n\n   * Current or lifetime diagnosis of any psychiatric disorders (e.g., schizophrenia, mood disorders, anxiety disorders) or history of substance\u002Fdrug abuse or dependence;\n   * First-degree family history of psychiatric disorders;\n   * Presence of severe systemic or neurological disorders, such as diabetes, hypertension, renal failure, hepatic dysfunction, thyroid disorders, encephalitis, traumatic brain injury, or epilepsy;\n   * Any other condition deemed inappropriate by the investigators.","13 Years","17 Years",{"count":59,"type":21},168,[24],"Major Depressive Disorder (MDD) is a chronic disease characterized by a high prevalence, low cure rate, and significant disability. Globally, depression is recognized as the leading cause of illness and disability among children and adolescents. Bright light therapy (BLT) has been established as an effective treatment for seasonal affective disorder and has demonstrated considerable efficacy in adult patients with MDD. However, its application in adolescent patients with MDD remains largely unexplored. The aim of this clinical trial is to evaluate the clinical efficacy, onset time, safety, and applicability of BLT in adolescents with MDD and to explore the potential neural mechanisms by which BLT enhances emotional and cognitive function in this population. This is a multicenter, randomized, controlled, double-blind study. It will involve adolescents aged 13 to 17 who are either untreated or have been stable on medication for at least one week. Adolescents with MDD will be randomly assigned to one of three groups: a high-intensity bright white light intervention group, a medium-intensity bright white light intervention group, and a placebo control group receiving dim red light. Each group will undergo four weeks of light exposure, six days per week, for 40 minutes daily between 6:30 and 10:00 AM. During the light exposure period, follow-up assessments will be conducted every weekend, and participants will be followed for two weeks after the completion of light exposure.The primary outcome will be the change in total scores on the 17-item Hamilton Rating Scale for Depression (HAMD-17) from baseline to week 4. Secondary outcomes will include response and remission rates, time to onset, maintenance of efficacy, self-reported depressive symptoms, sleep quality, cognitive function, anxiety, irritability, suicidal ideation, non-suicidal self-injury, self-efficacy, and the overall safety profile of BLT.\n\nAdditionally, the study will include healthy adolescent controls and collect functional Near-Infrared Spectroscopy (fNIRS) from both the adolescent participants with major depressive disorder and the healthy controls at baseline. The fNIRS and MRI data will also be collected from the adolescent participants with MDD at the end of the intervention, in order to investigate the potential neural mechanisms by which light therapy alleviates depressive symptoms in adolescents.",[63],"Depressive Disorder, Major",[65,34,66,67,68],"Depressive Disorder，Major","Adolescent","Neural Mechanisms","Randomised Controlled Trial","2026-04-16",{"date":71,"type":40},"2026-04-21",{"date":73,"type":40},"2025-03-17",{"date":39,"type":21},{"name":46,"class":47},3,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":4},"100618888","evidence-based-digital-cbt-for-nonsuicidal-self-injury-100618888","NCT07337473","Evidence-based Digital CBT for Nonsuicidal Self-Injury","Effect of Evidence-based Digital Cognitive Behavior Therapy for Adolescents With Nonsuicidal Self-Injury Disorder: A Randomized Clinical Trial","Inclusion Criteria:\n\n* 5 nonsuicidal self-injury episodes past year\n* 1 nonsuicidal self-injury episodes past month having at least one parent who committed to participate in the program\n\nExclusion Criteria:\n\nSevere suicidal ideation a diagnosis of psychotic or ongoing (past month) substance dependence the presence of co-occurring psychological disorders that required immediate treatment (i.e., severe anorexia nervosa)","12 Years","25 Years",{"count":87,"type":21},100,[24],"To evaluate if evidence-based digital cognitive behaviour therapy for adolescents is an efficacious treatment when delivered as an adjunctive treatment to treatment as usual, compared to a control group consisting of treatment as usual.",[91,92],"Non Suicidal Self Injury","Cognitive Behavior Therapy","NOT_YET_RECRUITING","2026-01-04",{"date":96,"type":40},"2026-01-13",{"date":98,"type":21},"2026-01-31",{"date":100,"type":21},"2027-01-30",{"name":46,"class":47},{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},"100606312","single-center-double-blind-randomized-placebo-controlled-study-on-efficacy-and-safety-of-rtms-with-precise-localization-in-relieving-motor-symptoms-of-td-100606312","NCT07173920","Single-Center, Double-Blind, Randomized, Placebo-Controlled Study on Efficacy and Safety of rTMS (With Precise Localization) in Relieving Motor Symptoms of TD","A Single-Center, Double-Blind, Randomized, Placebo-Controlled Clinical Study on the Efficacy and Safety of Repetitive Transcranial Magnetic Stimulation (rTMS) Under Precise Localization for Relieving Motor Symptoms of Tardive Dyskinesia","Inclusion Criteria:\n\n* (1) Age between 18 and 65 years; (2) Patients whose diagnosis is consistent with the tardive dyskinesia (TD) diagnostic criteria defined by the Schooler-Kane criteria, with a disease duration of at least 3 months before screening, and a history of treatment with dopamine receptor antagonists for at least 3 months (a minimum of 1 month for patients aged ≥ 60 years); other diseases that may cause involuntary movements are excluded\n\nExclusion Criteria:(1) Diagnosed with movement disorders other than tardive dyskinesia (TD); (2) A history of focal brain injury or severe leukoencephalopathy (Fazekas grade 3 or higher) identified on previous head MRI\u002FCT; (3) A personal history of epilepsy, unexplained loss of consciousness, or current use of anticonvulsant medications for seizure management; (4) Presence of metallic medical devices in the body (e.g., cardiac pacemakers, cochlear implants), other metallic foreign bodies, or any electronic devices implanted in the body; or having other contraindications to repetitive Transcranial Magnetic Stimulation (rTMS); (5) Presence of contraindications to MRI scanning, such as having metallic implants in the body or claustrophobia\n\n\\-","65 Years",{"count":111,"type":21},62,[24],"\\# Brief Summary (English Version) Tardive Dyskinesia (TD) is a hyperkinetic movement disorder induced by long-term use of dopamine receptor blockers and related drugs. Characterized by involuntary spasms or choreiform movements involving the tongue, lower face, jaw, and limbs (persisting for at least several weeks), TD causes irreversible neurological damage that persists even after discontinuing the causative drugs, significantly impairing patients' functional outcomes.\n\nrTMS is a non-invasive neuromodulation technique: time-varying currents in a coil generate magnetic fields that penetrate the scalp and skull to act on brain neurons, inducing depolarization, neural network activation, neurotransmitter release, metabolic changes, and gene expression, thereby producing physiological effects \\[9\\]. In recent years, rTMS has gained attention for treating movement disorders (e.g., Parkinson's disease, motor neuron disease, dystonia, essential tremor, Huntington's disease) due to its non-invasiveness, high safety, and repeatability. Studies have reported that rTMS can significantly improve motor symptoms in TD patients \\[10, 11\\]; however, existing research is limited by small sample sizes, conventional treatment parameters, large inter-individual variability, and unclear long-term efficacy.\n\nrTMS efficacy in TD is strongly influenced by parameters including stimulation targets, localization methods, sequences, and cycles. Optical navigation (using personalized MRI) is the most accurate and yields the best therapeutic effects, compared to manual localization or positioning caps . Regarding stimulation sequences, 1Hz and 20Hz rTMS have shown efficacy but with short-lived effects. Continuous theta-Burst Stimulation (cTBS)-a specialized rTMS mode that delivers rapid pulse trains mimicking endogenous theta-wave bursts-provides higher therapeutic doses in less time, enabling more durable efficacy and effectively reducing motor cortex excitability .\n\nTherefore, this study aims to investigate the effect of cTBS (under precise localization) on improving motor symptoms in patients with TD.",[115,116],"Tardive Dyskinesia","Repetitive Transcranial Magnetic Stimulation","2025-11-27",{"date":119,"type":40},"2025-12-05",{"date":121,"type":40},"2025-09-08",{"date":123,"type":21},"2028-12-30",{"name":46,"class":47},1,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":22,"phases":134,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":147,"leadSponsor":149,"locationsCount":4},"100575836","study-of-nitrate-rich-juice-on-cognitive-function-in-heavy-alcohol-drinkers-a-two-stage-adaptive-design-real-world-clinical-trial-100575836","NCT06777459","Study of Nitrate-Rich Juice on Cognitive Function in Heavy Alcohol Drinkers: a Two-Stage Adaptive Design Real-World Clinical Trial","Inclusion Criteria:\n\nA. Individuals with a history of heavy alcohol consumption (as defined below), who have continued heavy drinking within the past week and have no plans to quit drinking within the next month.\n\nB. Individuals with a history of heavy alcohol consumption who are currently hospitalized due to alcohol dependence or alcohol use disorder, and are still undergoing treatment.\n\nThe CDC (Centers for Disease Control and Prevention) defines heavy alcohol consumption as follows: For males: more than 15 standard alcoholic drinks per week. For females: more than 8 standard alcoholic drinks per week. Here, one standard drink unit is approximately 14 grams of pure alcohol- C. A Montreal Cognitive Assessment (MoCA) score greater than 13.\n\nExclusion Criteria:\n\nA. Individuals with a history of or current infectious diseases. B. Individuals with a history of or current severe cardiovascular, cerebrovascular, hepatic, or renal diseases.\n\nC. Individuals who are allergic to any substances used in the trial, such as beets.",{"count":133,"type":21},43,[24],"It is known that alcohol consumption can lead to cognitive impairment and dysregulation of inflammatory responses. A preliminary randomized controlled trial conducted by our research team has suggested that nitrate may improve cognition in hospitalized patients with alcohol dependence. To further expand the population and applicability, this study aims to explore the effects of nitrate on cognition in a real-world population of heavy drinkers. The researchers have designed a two-stage clinical trial: the first stage involves the analysis of existing data, and the second stage will recruit 43-54 new participants for a 14-day dietary inorganic nitrate (nitrate-rich beetroot juice, \\~750 mg NO3- \u002Fd) intervention.",[137],"Heavy Drinking",[137,139,140,141,142],"Cognitive Function","Nitrate","Two-stage adaptive design","Real World Study","2025-01-10",{"date":145,"type":40},"2025-01-15",{"date":145,"type":21},{"date":148,"type":21},"2025-12-31",{"name":46,"class":47},{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":156,"maxAge":17,"enrollmentInfo":157,"targetDuration":4,"studyType":22,"phases":159,"briefSummary":160,"conditions":161,"keywords":163,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":125},"100575441","an-exploratory-clinical-study-of-a-low-dose-buprenorphine-patch-for-the-treatment-of-autism-spectrum-disorders-100575441","NCT06772324","An Exploratory Clinical Study of a Low-dose Buprenorphine Patch for the Treatment of Autism Spectrum Disorders","Inclusion Criteria:\n\n* Sex: male\u002Ffemale;\n* Age:6-18 years at the time of randomization;\n* Clinical diagnosis in accordance with the DSM-5 diagnosis of ASD;\n* Diagnosis of ASD using the K-SADS-PL-C DSM-5 and CARS;\n* A severity score of ≥ 4 on the CGI scale;\n* Subjects must be able to participate and deemed suitable for participation in the study, at the investigator's discretion, and be able to follow the study evaluation schedule;\n* The parent or guardian agrees to accompany the subject to all clinical visits and to provide information about the subject's behavior and symptoms, and must agree to supervise the subject's compliance with protocol-specified procedures and the use of study drug doses;\n* The parent or guardian is willing and able to give written informed consent in accordance with local requirements. When the subject is capable of making the decision to consent to participation in the study, the subject is likewise willing and able to provide written informed consent in accordance with local requirements.\n\nExclusion Criteria:\n\n1. Neurologic\u002FPsychiatric Disorders\n\n   * Concurrent comorbidity with any other mental disorder (other than ADHD) as diagnosed by the K-SADS-PL-C DSM-5;\n   * Neurologic disorders or prior head trauma resulting in coma;\n   * Unstable or uncontrollable clinically significant psychiatric and\u002For neurological disorders that may interfere with safety or efficacy outcome;\n   * Unstable or uncontrolled irritability in the judgment of the investigator;\n   * Any suicide attempts in the opinion of the investigator at the time of screening that he\u002Fshe is at risk for suicidal behavior or in his\u002Fher medical history;\n   * A history of seizures within the past 6 months;\n   * A history of alcohol or other substance abuse\u002Fdependence.\n2. Cardiovascular Disease\n\n   * Current cardiovascular disease not effectively controlled in the opinion of the investigator;\n   * Clinically significant abnormalities (e.g., twice consecutive measurements) as confirmed by ECG at screening, including, but not limited to: QTc: ≥450 milliseconds, absence of predominant sinus rhythm, and second or third degree a-v block.\n3. Diseases of other organ systems\n\n   * Accompanying other diseases or conditions (pulmonary, gastrointestinal, hepatic, renal, metabolic, immune system, or obesity) that may interfere or whose treatment may interfere with the conduct of the study; or where, in the opinion of the Investigator, discontinuation of the Prohibited Substance may pose an unacceptable risk to the subject.\n   * Evidence of gastrointestinal bleeding, e.g., active gastric ulcer;\n   * History of coagulopathy, bleeding disorders or blood disorders;\n4. Other exclusion criteria\n\n   * Marked respiratory depression;\n   * Acute or severe bronchial asthma;\n   * Known or suspected paralytic bowel obstruction;\n   * Allergic to buprenorphine;\n   * Participation in a drug study within 30 days prior to randomization or within 5 times the half-life of the molecule to be studied, whichever is longer; or drug study; or participation in a study testing a medical device within 30 days prior to randomization, or the device is still in action. active;\n   * History of blood loss greater than 250 mL within 3 months prior to screening;\n   * Medications permitted since 4 weeks prior to screening that have NOT been clearified and stable, and medications permitted for the treatment of epilepsy since 3 months prior to screening that have NOT been clearified and stable.\n   * Usage of a prohibited medication within 2 weeks prior to the screening visit (and ensuring at least 4 weeks of washout time prior to the baseline assessment) or usage of a prohibited medication within 5 times of half-life prior to the randomization (whichever is longer).","6 Years",{"count":158,"type":21},60,[24],"This study evaluates the safety and efficacy of low-dose buprenorphine in patients with ASD by using standard ASD symptom assessment methods (e.g., SRS-2 and ABC) as well as AI-assisted analyses utilizing exploratory gaze patterns in conjunction with fMRI and electroencephalogram measurements to assess changes in brain functional status.",[162],"Autism Spectrum Disorder",[164,165,166],"low-dose Buprenorphine patch","autism spectrum disorders","Buprenorphine","2025-01-08",{"date":169,"type":40},"2025-01-13",{"date":171,"type":21},"2025-01",{"date":173,"type":21},"2026-09",{"name":46,"class":47},""]