[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655928":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":49,"studyPopulation":42,"armGroups":50,"interventions":57,"overallOfficials":63,"centralContacts":67,"locations":76,"responsibleParty":97,"collaborators":100,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":42,"eligibilityCriteria":109,"healthyVolunteers":105,"sex":110,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":42,"studyType":116,"phases":117,"briefSummary":118,"conditions":119,"keywords":123,"overallStatus":79,"whyStopped":42,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"Faculty of Medicine, Sousse","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":42},[9,13],{"measure":10,"description":11,"timeFrame":12},"Body weight","Body weight, measured using a calibrated scale integrated into the bioelectrical impedance analyzer, with participants wearing light clothing.","baseline (T0), day 10 (T1), day 45 (T2), and day 90 (T3)",{"measure":14,"description":15,"timeFrame":12},"Waist circumference","Waist circumference, measured at the narrowest point between the lower rib margin and the iliac crest, as an indicator of abdominal adiposity.",[17,20,23,26,29,32,35,39],{"measure":18,"description":19,"timeFrame":12},"Other anthropometric measurements","Other anthropometric measurements including mid-upper arm circumference measured at the midpoint of the relaxed arm, and mid-thigh circumference measured at the midpoint of the thigh.",{"measure":21,"description":22,"timeFrame":12},"Body composition","Body composition, assessed via bioelectrical impedance analysis, including body fat percentage, muscle mass percentage, and body water percentage.",{"measure":24,"description":25,"timeFrame":12},"Concentration of Triglycerides","Fasting serum triglyceride (TG) concentration",{"measure":27,"description":28,"timeFrame":12},"Concentration of High-Density Lipoprotein Cholesterol","Fasting serum High-Density Lipoprotein Cholesterol (HDL-C) concentration",{"measure":30,"description":31,"timeFrame":12},"Concentration of Low-Density Lipoprotein Cholesterol","Fasting serum Low-Density Lipoprotein Cholesterol (LDL-C) concentration",{"measure":33,"description":34,"timeFrame":12},"Fasting Blood Glucose Level","Fasting plasma glucose concentration",{"measure":36,"description":37,"timeFrame":38},"Glycated Hemoglobin (HbA1c) Level","Percentage of glycated hemoglobin (HbA1c)","baseline (T0) and day 90 (T3)",{"measure":40,"description":41,"timeFrame":12},"Incidence of treatment-emergent abnormalities in Complete Blood Count, renal function, and hepatic Enzymes","Number of participants with clinically significant treatment-emergent abnormalities in complete blood count (CBC), renal function markers, or hepatic enzymes during the 90-day intervention period.",null,{"allocation":44,"interventionModel":45,"interventionModelDescription":42,"primaryPurpose":46,"observationalModel":42,"timePerspective":42,"maskingInfo":47},"NA","SINGLE_GROUP","TREATMENT",{"masking":48,"maskingDescription":42,"whoMasked":42},"NONE","A pilot, pre-experimental study will be conducted.\n\n1. Study population Patients will be recruited from the outpatient Department of Psychiatry at Farhat Hached Hospital (Sousse, Tunisia). Inclusion criteria are: (1) a diagnosis of treatment-resistant schizophrenia; (2) current treatment with clozapine monotherapy or clozapine combined with other psychotropics that have a minimal documented impact on body weight; (3) demonstration of a response to clozapine, defined as a reduction of at least 20% in the total score on the Positive and Negative Syndrome Scale (PANSS) or the Brief Psychiatric Rating Scale (BPRS) after 8-12 weeks of treatment at effective therapeutic doses; and (4) presence of obesity (Body Mass Index (BMI) \\> 30 kg\u002Fm²) or central obesity (waist circumference \\> 94 cm in men and \\> 80 cm in women), which developed following clozapine introduction. Non-inclusion criteria are: (1) concurrent use of clozapine with other psychotropic agents that have a documented moderate-to-high influence on body weight; (2) current treatment with metformin; and (3) pregnancy or breastfeeding.\n2. Study procedure Eligible patients with treatment-resistant schizophrenia will be invited to take a daily Nitraria retusa extract infusion at approximately 9 PM for 90 consecutive days, as an adjunct to their usual medications. Patients will be instructed to maintain their usual diet, routine, and lifestyle throughout the study. Clinical and biological evaluations will be conducted prospectively at baseline (T0), day 10 (T1), day 45 (T2), and day 90 (T3).\n3. Plant material and preparation of Nitraria retusa extract Nitraria retusa was collected from saline soils in Kairouan (central Tunisia). The leaves were rinsed with water, air-dried in the shade at room temperature for 15 days, and crushed into a fine powder using a Moulinex grinder (MOULINEX SA, France). Nitraria retusa was supplied to participants in sachets containing 2,000 mg of powder. Participants were instructed to prepare the daily infusion by steeping 2,000 mg of the powder in 100 mL of boiled water for 15 minutes. Qualitative and quantitative analyses of the extract were performed using a validated ultra-high-performance liquid chromatography with diode-array detection method (UHPLC-DAD; SHIMADZU 8045).\n4. Outcome variables Outcome measures were categorized as primary and secondary.\n\n   Primary outcomes included:\n   * Body weight, measured using a calibrated scale integrated into the bioelectrical impedance analyzer, with participants wearing light clothing.\n   * Waist circumference, measured at the narrowest point between the lower rib margin and the iliac crest, as an indicator of abdominal adiposity.\n\n   Secondary outcomes encompassed:\n   * Other anthropometric measurements including mid-upper arm circumference measured at the midpoint of the relaxed arm, and mid-thigh circumference measured at the midpoint of the thigh.\n   * Body composition, assessed via bioelectrical impedance analysis, including body fat, muscle mass, and body water percentages.\n   * Metabolic panels, including triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), fasting blood glucose, and glycated hemoglobin (HbA1c).\n   * Intervention tolerability, monitored via CBC, renal function markers, and hepatic enzymes.\n5. Ethical considerations Each participant provided written informed consent after receiving a detailed oral explanation of the study objectives and procedure, and after being given the written information sheet. Participants were also informed about their rights to withdraw at any time without any impact on the quality of their clinical care. All data were handled confidentially.",[51],{"label":52,"type":53,"description":54,"interventionNames":55},"Treatment-resistant schizophrenia patients' with clozapine-induced obesity","EXPERIMENTAL","Inclusion criteria: (1) a diagnosis of treatment-resistant schizophrenia\\]; (2) current treatment with clozapine monotherapy or clozapine combined with other psychotropics that have a minimal documented impact on body weight; (3) demonstration of a response to clozapine, defined as a reduction of at least 20% in the total score on the Positive and Negative Syndrome Scale (PANSS) or the Brief Psychiatric Rating Scale (BPRS) after 8-12 weeks of treatment at effective therapeutic doses; and (4) presence of obesity (BMI \\> 30 kg\u002Fm²) or central obesity (waist circumference \\> 94 cm in men and \\> 80 cm in women), which developed following clozapine introduction.\n\nNon-inclusion criteria: (1) concurrent use of clozapine with other psychotropic agents that have a documented moderate-to-high influence on body weight; (2) current treatment with metformin; and (3) pregnancy or breastfeeding.",[56],"Dietary Supplement: The Nitraria retusa arm",[58],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":42},"DIETARY_SUPPLEMENT","The Nitraria retusa arm","A daily administration of Nitraria retusa extract infusion at approximately 9 PM for 90 consecutive days, as an adjunct to patients' usual medications, while maintaining usual diet, routine, and lifestyle throughout the study.\n\nNitraria retusa was collected from saline soils in Kairouan (central Tunisia). The leaves were rinsed with water, air-dried in the shade at room temperature for 15 days, and crushed into a fine powder using a Moulinex grinder (MOULINEX SA, France). Nitraria retusa was supplied to participants in sachets containing 2,000 mg of powder. Participants were instructed to prepare the daily infusion by steeping 2,000 mg of the powder in 100 mL of boiled water for 15 minutes. Qualitative and quantitative analyses of the extract were performed using a validated high-performance liquid chromatography method (UHPLC-DAD, SHIMADZU 8045).",[52],[64],{"name":65,"affiliation":5,"role":66},"Saad Saguem, Professor","STUDY_DIRECTOR",[68,73],{"name":69,"role":70,"phone":71,"phoneExt":42,"email":72},"Bochra Nourhène Saguem, M.D.; Associate Professor","CONTACT","+21655617728","saguem.bochra@gmail.com",{"name":65,"role":70,"phone":74,"phoneExt":42,"email":75},"+21653673851","khaled_saguem@yahoo.fr",[77],{"facility":78,"status":79,"city":80,"state":42,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"Farhat Hached University Hospital","RECRUITING","Sousse","4000","Tunisia","TN",{"type":85,"coordinates":86},"Point",[87,88],10.63699,35.82539,{"lat":88,"lon":87},[91,92,95],{"name":69,"role":70,"phone":71,"phoneExt":42,"email":72},{"name":93,"role":94,"phone":42,"phoneExt":42,"email":42},"Jaâfar Nakhli, Professor","SUB_INVESTIGATOR",{"name":69,"role":96,"phone":42,"phoneExt":42,"email":42},"PRINCIPAL_INVESTIGATOR",{"type":96,"investigatorFullName":98,"investigatorTitle":99,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Bochra Nourhène Saguem","Psychiatrist, CBT psychotherapist, Music Therapist at the Psychiatry Department, Farhat Hached Hospital, Sousse; Associate professor in psychiatry, Faculty of Medicine of Sousse",[101],{"name":102,"class":6},"University of Tsukuba","100655928","effects-of-nitraria-retusa-infusion-on-clozapine-induced-metabolic-side-effects-100655928",false,"NCT07817069","Effects of Nitraria Retusa Infusion on Clozapine-induced Metabolic Side Effects","Efficacy of Nitraria Retusa Infusion in Significantly Reducing Clozapine-induced Metabolic Side Effects in Patients With Treatment-resistant Schizophrenia: A Pre-Experimental Pilot Study","Inclusion Criteria:\n\n* a diagnosis of treatment-resistant schizophrenia;\n* current treatment with clozapine monotherapy or clozapine combined with other psychotropics that have a minimal documented impact on body weight; - demonstration of a response to clozapine, defined as a reduction of at least 20% in the total score on the Positive and Negative Syndrome Scale (PANSS) or the Brief Psychiatric Rating Scale (BPRS) after 8-12 weeks of treatment at effective therapeutic doses;\n* presence of obesity (BMI \\> 30 kg\u002Fm²) or central obesity (waist circumference \\> 94 cm in men and \\> 80 cm in women), which developed following clozapine introduction.\n* free informed written consent\n\nExclusion Criteria:\n\n* concurrent use of clozapine with other psychotropic agents that have a documented moderate-to-high influence on body weight\n* current treatment with metformin\n* pregnancy or breastfeeding\n* non acceptance to take part to the study","ALL","18 Years","65 Years",{"count":114,"type":115},30,"ESTIMATED","INTERVENTIONAL",[44],"The primary objective of the study is to assess the efficacy and tolerability of a 90-day daily supplementation with a Nitraria retusa dried crushed leaves infusion on the iatrogenic metabolic side effects induced in patients with treatment-resistant schizophrenia following clozapine treatment.\n\nAfter providing written informed consent, eligible patients with treatment-resistant schizophrenia will be invited to receive a daily Nitraria retusa extract infusion at approximately 9 PM for 90 consecutive days, as an adjunct to their usual medications. Patients will be instructed to maintain their usual diet, routine, and lifestyle throughout the study.\n\nClinical and biological evaluations will be conducted prospectively at baseline (T0), day 10 (T1), day 45 (T2), and day 90 (T3). Two additional assessments will be planned at day 30 and day 60 to comply with the monthly complete blood count (CBC) surveillance recommended for patients receiving clozapine. Assessments include anthropometric measures, body composition, vital signs, CBC, metabolic panels, and renal and hepatic function. All biological samples were collected after a 12-hour fast.",[120,121,122],"Treatment Resistant Schizophrenia","Obesity & Overweight","Abdominal Obesity",[124,125,126,127,128,129,130],"Nitraria retusa","Flavonoids","Clozapine","Treatment-resistant schizophrenia","Metabolic syndrome","Obesity","Antipsychotic-induced weight gain","2026-09-09",{"date":133,"type":134},"2026-09-14","ACTUAL",{"date":136,"type":134},"2026-01-03",{"date":138,"type":115},"2028-12",{"name":5,"class":6},1]