[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"schizophrenia-negative-type\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:schizophrenia-negative-type":52},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,39,70],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100630290","early-phase-1-safety-and-feasibility-of-nasal-delivery-of-human-dental-follicle-mesenchymal-stem-cell-derived-exosomes-for-negative-symptoms-in-treatment-resistant-schizophrenia-a-pilot-study-100630290",false,"NCT07485751","Safety and Feasibility of Nasal Delivery of Human Dental Follicle Mesenchymal Stem Cell-Derived Exosomes for Negative Symptoms in Treatment-Resistant Schizophrenia: A Pilot Study","Inclusion Criteria:\n\n1\\) Conforms to the ICD-10 diagnosis of schizophrenia; 2) age between 18 and 60 years old; 3) course of more than 5 years of long-term inpatients; 4) the last 6 months without acute aggravating period, and no change in recent two months regimen; 5) to including clozapine, two different antipsychotics enough poor foot therapy treatment response; 6) positive and negative symptoms scale - negative symptom factor (PANSS - FSNS) 24 or more; 7) three core of PANSS negative symptoms (N1, N4 interchange and N6) at least 2 or 4; 6) clinical overall impression scale - illness severity (-s) CGI score of 4 or more points; 7) signed a written informed consent.\n\nExclusion Criteria:\n\n1\\) Has a history of severe allergies; 2) there is a clear brain organic disease; 3) with serious body disease (such as the instability of coronary artery disease, malignant arrhythmia, liver and kidney function is not complete, bronchial asthma, COPD acute aggravating period, autoimmune diseases, etc.); 4) there is accord with the ICD - 10 patients with other psychiatric diagnosis standard sample obstacles (such as schizoaffective disorder, schizophrenia, bipolar I disorder, bipolar type Ⅱ dysfunction, broad developmental disabilities, mental retardation, delirium, dementia, forgotten obstacles or other cognitive impairment, etc.); 5) condition fluctuation, the need to adjust the drug solution; 6) don't cooperate with treatment, 7) with severe rhinitis, nasal allergies; 8) for nearly three months has a history of MECT therapy; 9) suicide risk; 10) during pregnancy or lactation women, female or male subjects and spouse has pregnancy at the time of test plan or over 3 months to test is not willing to use effective contraception (effective contraceptive measures such as birth control pills and condoms or intrauterine device, etc.); 11) other unfavorable into groups.","ALL","18 Years","60 Years",{"count":19,"type":20},15,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","The goal of this clinical trial is to determine the safety and feasibility of nasal delivery of human dental follicle mesenchymal stem cell-derived exosomes in the treatment of negative symptoms of treatment-resistant schizophrenia. It will also learn about the preliminary efficacy of the exosomes. The main questions it aims to answer are:\n\nIs the safety of the exosomes enough for participants? Is the feasibility of nasal delivery of exosomes for participants? Do the exosomes exert any benefits on the negative symptoms of treatment-resistant schizophrenia?\n\nParticipants will:\n\nTake a nasal spray of exosomes twice weekly for 2 months Take vital sign checks every day, regular visits for an interview, and lab examinations",[26],"Schizophrenia Negative Type","NOT_YET_RECRUITING","2026-03-16",{"date":30,"type":31},"2026-03-20","ACTUAL",{"date":33,"type":20},"2026-03",{"date":35,"type":20},"2026-12",{"name":37,"class":38},"Zigong Mental Health Center","OTHER",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":21,"phases":48,"briefSummary":50,"conditions":51,"keywords":54,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100584391","efficacy-of-hi-tacs-for-schizophrenia-negative-symptoms-100584391","NCT06888726","Efficacy of Hi-tACS for Schizophrenia Negative Symptoms","Efficacy of High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS) in Treating Negative Symptoms of Schizophrenia","Inclusion Criteria:\n\n* Han Chinese population;\n* Age ≥ 18 years;\n* Education level ≥ 6 years, able to fill out questionnaires on their own, and having sufficient audiovisual level to complete the necessary examinations;\n* Meets DSM-5 diagnostic criteria for schizophrenia as assessed by MINI 7.0;\n* Residual negative symptoms, with at least one item ≥2 on the negative subscale of PANSS (N1-N7);\n* Taking second-generation atypical antipsychotic medication, with no medication or dosage adjustments in the last two weeks\n* Patients and guardians agreed to participate in the study and signed an informed consent form.\n\nExclusion Criteria:\n\n* Meets DSM-5 diagnostic criteria for other mental disorders;\n* Total score ≥19 on the PANSS positive subscales (P1-P7) ;\n* Severe negative symptoms that prevent the patient from completing the required assessments and interventions;\n* Serious physical or central nervous system disease (intracranial infection, intracranial tumor, presence of metal objects in the skull; epilepsy, seizures; history of hydrocephalus or central nervous system tumors; with implanted electronic devices; serious cardiac disease and fitted with a pacemaker, etc.);\n* Impaired skin integrity at the site of electrode placement or hypersensitivity to electrode gels or adhesives;\n* Mental retardation (Wechsler Adult Intelligence Scale WAIS \\\u003C70) and\u002For severe cognitive impairment (Brief Mental State Examination MMSE \\\u003C24);\n* Presence of vision and\u002For hearing problems that prevent completion of relevant tests;\n* Alcohol or drug abuse\u002Fdependence;\n* Pregnancy;\n* Those who have participated or are participating in other clinical studies 3 months ago;\n* Failure or refusal to sign the informed consent form.",{"count":47,"type":20},60,[49],"NA","The goal of this clinical trial is to investigate whether Hi-tACS is effective and safe in treating negative symptoms of schizophrenia.\n\nSchizophrenic patients will receive treatment (Hi-tACS or shame stimulation) for 2 weeks.\n\nNegative symptoms, cognitive functioning, social functioning, and quality of life of intervention group and control group were assessed and compared between the two groups at baseline, 2 weeks, and 3 months post-intervention.",[52,53],"Schizophrenia; Negative Type","Transcranial Alternating Current Stimulation",[55,56,57,58],"Hi-tACS","Schizophrenia","Randomized Controlled Trial","Negative symptoms","RECRUITING","2025-05-29",{"date":62,"type":31},"2025-06-04",{"date":64,"type":31},"2024-06-27",{"date":66,"type":20},"2026-11-30",{"name":68,"class":38},"Shanghai Mental Health Center",1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":15,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":69},"100543103","phase-3-an-open-label-single-arm-study-of-the-efficacy-of-accelerated-intermittent-theta-burst-stimulation-in-schizophrenia-patients-with-persistent-negative-symptoms-100543103","NCT06351514","An Open-Label, Single Arm Study of the Efficacy of Accelerated Intermittent Theta Burst Stimulation in Schizophrenia Patients With Persistent Negative Symptoms","NOBLE-TMS","Inclusion Criteria:\n\n1. Age ≥21 and ≤65 years;\n2. With primary diagnosis of schizophrenia or schizoaffective disorder;\n3. Patients experienced prominent and persistent negative symptoms \\[Scale for the Assessment of Negative Symptoms (SANS) score ≥3 or Positive and Negative Symptoms Scale (PANSS)- negative subscale score ≥20\\] in past 6 months;\n4. No clinically significant positive symptoms \\[PANSS positive subscale score \\\u003C20\\];\n5. No clinically significant depressive symptoms \\[Calgary Depression Scale for Schizophrenia (CDSS) score subscale \\\u003C12\\];\n6. Able to give consent.\n\nExclusion Criteria:\n\n1. With current misuse of or dependence on illegal drugs or alcohol;\n2. High Suicide risk;\n3. History of epileptic seizures;\n4. With severe brain trauma, injury or other neurological diseases;\n5. Metal (implants) in the skull;\n6. Pregnancy","21 Years","65 Years",{"count":80,"type":20},40,[82],"PHASE3","Schizophrenia patients commonly present with persistent negative symptoms which remain the main reason for dysfunction after recovery from an acute episode of psychotic symptoms. Negative symptoms in schizophrenia exact significant burden with no effective pharmacological or behavior treatment options thus far. Neuromodulatory modalities present a novel and alternative treatment approach and recent trials have shown preliminary evidence for the efficacy of intermittent Theta Burst Stimulation (iTBS) to treat negative symptoms in schizophrenia. In this study, we aim to examine the effectiveness of an accelerated iTBS treatment protocol as an augmentation treatment regime for patient in rehabilitation care with persistent negative symptoms.\n\nWe propose a pragmatic, open label and single arm clinical trial. Forty patients with diagnosis of schizophrenia, who had been stabilized from psychotic symptoms and currently suffering from dominant negative symptoms will be recruited and undergo accelerated iTBS treatment for 5 consecutive sessions each day for 5 working days. Participants will be followed up immediately, 1 month and 3 months after the end of treatment. Clinical assessment includes, BNSS, The Brief Negative Symptom Scale; SANS, Scale for the assessment of negative symptoms; SAPS, Scale for the assessment of positive symptoms; PANSS, Positive and Negative Symptoms Scale; MoCA, Montreal Cognitive Assessment scale; CDSS, Calgary Depression Scale for Schizophrenia: SDS, Sheehans' disability scale and EQ-5D. The primary endpoint of the trial is the change of negative symptoms as assessed by PANSS, negative symptoms subscale immediately after the treatment.\n\nThis study will determine whether accelerated iTBS is effective to be delivered as an augmentation therapy for patients with persistent negative symptoms. The optimal treatment system for this population can be immediately translated to clinical practice and benefit patients in need.",[52],"2024-04-02",{"date":87,"type":31},"2024-04-08",{"date":89,"type":31},"2024-04-01",{"date":91,"type":20},"2026-09",{"name":93,"class":38},"Institute of Mental Health, Singapore"]