[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"clozapine\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:clozapine":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"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},"100564858","phase-4-clozapine-related-immunodeficiency-in-parkinsons-disease-100564858",false,"NCT06634641","Clozapine-related Immunodeficiency in Parkinsons Disease","Assessment of Clozapine-related Immunodeficiency Effect in Parkinsons Disease Patients","CLOZIDPD","Inclusion Criteria:\n\n* Patient ≥ 18 years old with Parkinson's disease according to MDS 2015 criteria\n* Psychotic symptoms requiring treatment with Clozapine\n* Patients with initially a normal leukocyte count (number of white blood cells\n\n  ≥ 3500\u002Fmm3 \\[3.5 x 109\u002Fl\\] and an absolute neutrophil count PNN ≥ 2000\u002Fmm3 \\[2 x 109\u002Fl\\])\n* patients in whom the number of white blood cells (WBC) and the absolute number of neutrophils (PNN) may be determined regularly at the following intervals: once a week during the first 18 weeks of treatment and, thereafter, at least every 4 weeks for the duration of the treatment. This monitoring must be continued throughout the treatment and for 4 weeks who follow the complete cessation of CLOZAPINE\n* Informed and written consent.\n* Affiliation to a social security system\n\nExclusion Criteria:\n\n* Patients with a contraindication to the use of Clozapine according to the summary of product characteristics (SPC)\n* Hypersensitivity to the active substance or to any of the excipients.\n* Patients who cannot receive regular blood tests.\n* History of granulopenia or toxic or idiosyncratic agranulocytosis (unless it results from previous chemotherapy).\n* History of agranulocytosis induced by CLOZAPINE\n* Treatment with CLOZAPINE should not be started at the same time as substances known to have a high potential for inducing agranulocytosis; The concomitant administration of depot antipsychotics is not recommended.\n* Functional bone marrow failure.\n* Uncontrolled epilepsy.\n* Alcoholic or induced psychosis, drug intoxication, comatose states.\n* Circulatory collapse and \u002F or CNS depression regardless of the aetiology.\n* Severe renal or cardiac disorders (eg: myocarditis).\n* Active liver disease with nausea, anorexia or jaundice; progressive liver disease, liver failure.\n* Paralytic ileus.\n* Patient with another potential cause of immunosuppression\n* Immunosuppressive or immune modulatory treatment active or stopped for less than 5 years\n* Anti-epileptic treatment active or stopped for less than 5 years\n* Chemotherapy active or stopped for less than 5 years\n* Solid or hematologic cancer active or treated for less than 5 years\n* Human immunodeficiency virus infection\n* Already known constitutional immune deficiency\n* Nephrotic syndrome\n* Protein-losing enteropathy\n* A history of radiotherapy\n* Long-term use of corticosteroids\n* Patient with potentially major cognitive disorders defined by a MoCA score less than or equal to 23\n* Pregnant or breastfeeding women\n* Patient under guardianship\u002Fcuratorship or deprived of liberty","ALL","18 Years",{"count":20,"type":21},24,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","Clozapine is a second generation antipsychotic drug used in psychiatry to treat schizophrenia, affective disorders or certain symptoms of dementia. In neurology, clozapine is frequently used and recommended to manage symptoms of psychosis associated with Parkinson's disease (PD). The risk of neutropenia or agranulocytosis associated with clozapine estimated at 1.3% is well known to doctors around the world with a peak at one month and a decrease in risk after more than a year of treatment. This risk has led to the policy of \"no blood, no drugs\" and monitoring of the complete blood count (CBC) weekly for 18 weeks and then monthly for the duration of treatment.\n\nSome studies suggest an increased risk of infections related to immunodeficiency induced by clozapine itself. This clozapine-induced immunodeficiency would be comparable to that encountered in patients with common variable immunodeficiency or under immunosuppressive treatment. In addition, this immunosuppressive effect linked to clozapine would not be dose dependent but time dependent. However, the only studies currently performed have been in psychiatric patients treated for schizophrenia.\n\nIt seems important to specifically explore clozapine-related immunodeficiency in PD patients treated with clozapine for PD-related psychosis. In this study, the investigators propose to evaluate the variations in serum immunoglobulin levels and lymphocyte subpopulations (B, T, NK) in parkinsonian patients treated with Clozapine at 6 months and 1 year after initiation of treatment.",[27,28,29,30],"Clozapine","Parkinson's Disease (PD)","Immunodeficiency","Psychosis",[32,33,34,35],"clozapine","parkinson's disease","immunodeficiency","psychosis","RECRUITING","2025-11-17",{"date":39,"type":40},"2025-11-19","ACTUAL",{"date":42,"type":40},"2024-10-01",{"date":44,"type":21},"2027-09",{"name":46,"class":47},"Centre Hospitalier Universitaire, Amiens","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":48},"100599492","early-phase-1-a-clinical-study-of-the-safety-and-efficacy-of-chemogenetics-therapy-in-the-treatment-of-parkinsons-disease-100599492","NCT07085195","A Clinical Study of the Safety and Efficacy of Chemogenetics Therapy in the Treatment of Parkinson's Disease","Inclusion criteria\n\nParticipants who meet all the following criteria can be included in this clinical study:\n\n1. Clinically diagnosed with idiopathic Parkinson's Disease \\[in accordance with the Diagnostic Criteria for Parkinson's Disease in China published in 2016, or in accordance with the Diagnostic Criteria for Primary PD of the International Parkinson's and Movement Disorders Society (MDS) in 2015\\];\n2. Subjects aged 40-65 years old (including the boundary value), regardless of gender;\n3. Medical history of disease ≥5 years;\n4. Hoehn-Yahr staging scale for \"off\" period is 2.5-4;\n5. Regular use of dopaminergic drugs before the screening period, including taking levodopa for at least 4 weeks;\n6. MDS-UPDRS III score \\>35 in the \"off\" period, and the improvement rate of acute levodopa stress test ≥30%;\n7. AAV neutralizing antibody titer ≤1:2000;\n8. The subject agrees to postpone other neurosurgery during the main study phase (including deep brain stimulation, except for sudden life-threatening conditions requiring neurosurgery during the trial);\n9. No acute adverse reactions to the scheduled therapeutic dose of clozapine (1-month observation period);\n10. The subject agrees not to participate in other therapeutic intervention studies during the trial;\n11. The subject agrees not to be vaccinated during the study phase;\n12. Use reliable contraceptive methods from the screening period to at least 8 weeks after drug infusion;\n13. The subject has good compliance and can follow up regularly. During the follow-up period, the PD patient diary can be accurately completed. Family members, guardians, or caregivers can help the subject fill in the patient diary;\n14. The subject fully understands the nature, purpose, methods, and possible adverse reactions of this clinical trial, voluntarily participates as a subject, and signs the informed consent form; if the subject is unable to read, the legal agent or impartial witness can read the informed consent form and other written materials and witness the informed consent.\n\nExclusion criteria\n\nIf any of the following criteria are met, the patient shall be excluded from this study:\n\n1. Atypical or secondary Parkinson's syndrome (such as Parkinson's plus syndrome, hereditary Parkinson's syndrome, drug-induced Parkinson's syndrome);\n2. Contraindications to surgery or previous deep brain stimulation surgery, pallidotomy, extrapyramidal surgery, other brain surgeries, or other neurosurgery that the researcher determines will affect their participation in this trial;\n3. Previous cranial imaging suggests abnormal brain structure, cerebrovascular malformations, intracranial tumors, intracranial hemorrhage risk, brain trauma, and other abnormalities;\n4. Mini-Mental State Examination (MMSE) score \\\u003C24 points;\n5. Montreal Cognitive Assessment (MoCA) score \\\u003C26 points;\n6. Mini-Mental State Questionnaire (PHQ-9) ≥16;\n7. Abnormal liver and kidney function: Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \\> 1.5 times the upper limit of normal value, serum creatinine (Cr) \\>1.5 times the upper limit of normal value;\n8. Abnormal coagulation function or using anticoagulants;\n9. Infectious disease screening: Hepatitis B surface antigen (HBsAg) or hepatitis B virus DNA (HBV-DNA) positive, hepatitis C virus RNA (HCV-RNA) positive, human immunodeficiency virus (HIV) positive, or syphilis serum positive;\n10. Undergoing antiviral treatment for hepatitis B and hepatitis C;\n11. Suffering from unstable or severe other systemic diseases: including active tuberculosis, cardiovascular system, respiratory system, Diseases of the digestive system, urinary system, mental and nervous system (such as epilepsy), blood system, immune system, etc., or abnormal laboratory test values, the investigator determines that the patient is not suitable for participating in this trial;\n12. Suffering from malignant tumors or having a history of malignant tumors;\n13. Having had severe allergic reactions, allergic to contrast agents, or being unable to accept surgical anesthesia;\n14. Participating in other clinical trials or having participated in other clinical trials within 3 months before the screening period;\n15. Having received gene therapy before being enrolled into this trial;\n16. Having received stem cell therapy within 6 months before the screening period;\n17. Having used other investigational drugs within 4 weeks before screening or within 5 half-lives of the investigational drug (whichever is longer), or drugs that the investigator determines affect this trial;\n18. Having received live vaccines within 2 months before the screening period or having a history of vaccination within 30 days before the screening period;\n19. Have a history of alcohol dependence or drug addiction and cannot stop drinking as advised by the doctor during the trial;\n20. Female subjects who are pregnant or breastfeeding;\n21. Severe motor complications after anti-PD drug treatment and no suitable alternative treatment options;\n22. Subjects who are assessed by the researchers as unsuitable for inclusion.","40 Years","65 Years",{"count":58,"type":21},6,[60],"EARLY_PHASE1","The investigators propose a gene therapy strategy using chemical genetic inhibition to intervene in the abnormal activity of the subthalamic nucleus in Parkinson's disease. The investigators design and construct a highly efficient therapeutic injection STP-001 (first drug), through the efficient adeno-associated virus capsid (AAV), neuronal promoter (hSyn), and chemical genetic effector element (hM4Di), and accurately inject the drug into the bilateral subthalamic nucleus, the core pathological nucleus of Parkinson's disease, through stereotactic technology. Combined with a very low dose of clozapine (the second drug), the abnormal activity of the subthalamic nucleus is precisely intervened to improve the core motor symptoms of Parkinson's disease.",[63,64,65,27],"Parkinson Disease (PD)","Gene Therapy","Safety and Efficacy","NOT_YET_RECRUITING","2025-07-24",{"date":69,"type":40},"2025-07-25",{"date":71,"type":21},"2025-08-01",{"date":73,"type":21},"2025-12-30",{"name":75,"class":47},"Ruijin Hospital",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":17,"minAge":18,"maxAge":56,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":48},"100560144","effect-of-exercise-on-clinical-symptoms-cognitive-performance-and-quality-of-life-in-schizophrenia-patients-treated-with-clozapine-100560144","NCT06573320","Effect of Exercise on Clinical Symptoms, Cognitive Performance, and Quality of Life in Schizophrenia Patients Treated With Clozapine","Investigating the Effect of Exercise on Clinical Symptoms, Cognitive Performance, and Quality of Life in Schizophrenia Patients Treated With Clozapine","Inclusion Criteria:\n\n* Patients treated who were diagnosed with schizophrenia according to DSM-V criteria by psychiatrist at the Turkish Ministry of Health Kartal Dr. Lütfi Kırdar City Hospital\n* using a therapeutic dose of 300-500 mg\u002Fday of clozapine,\n\nExclusion Criteria:\n\n* pregnancy",true,{"count":85,"type":21},60,[87],"NA","This prospective study aims to investigate the effects of exercise on clinical symptoms, cognitive performance, and quality of life in schizophrenia patients treated with Clozapine.",[90,27,91],"Schizophrenia","Exercise","2024-08-24",{"date":94,"type":40},"2024-08-27",{"date":96,"type":40},"2024-03-14",{"date":98,"type":21},"2024-08-31",{"name":100,"class":101},"Dr. Lutfi Kirdar Kartal Training and Research Hospital","OTHER_GOV"]