[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06174116":3,"trial-entities:NCT06174116":147,"trial-summary:NCT06174116":151},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":41,"secondary_outcomes":77,"sex":96,"minimum_age":97,"maximum_age":98,"healthy_volunteers":14,"eligibility_criteria":99,"std_ages":116,"locations":119,"central_contacts":138,"overall_officials":142,"references":145,"see_also_links":146},"NCT06174116","STUDY00001339","Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia","RECRUITING","2027-03","2026-05","2026-05-22","2024-04-02","University of Massachusetts, Worcester","OTHER",false,"The main question this study is trying to answer is whether lumateperone, an FDA-approved antipsychotic drug, can help reduce possible side effects of clozapine, such as weight gain and elevated levels of sugar and bad cholesterol.\n\nParticipants will be randomly assigned to either take lumateperone (Caplyta) or a placebo for 12 weeks, in addition to their regularly prescribed clozapine. During their participation, patients will answer questions about their psychiatric and daily functioning, have blood drawn, and have their body composition analyzed (similar to stepping on a scale).","This is a 12-week study in which we investigate how adjunctive lumateperone affects lipid particle size and body composition in clozapine-treated patients with schizophrenia; in addition, we will investigate if lumateperone improves insomnia. Outcome measures will record a variety of assessments related to participants' psychiatric symptoms, psychosocial functioning, and biological outcomes.",[18,19],"Schizophrenia","Schizo Affective Disorder",[21],"Clozapine","INTERVENTIONAL","TREATMENT",[25],"PHASE4",{"count":27,"type":28},50,"ESTIMATED",[30,37],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Lumateperone","Subject will take lumateperone (Caplyta) for 12 weeks, in addition to their regular medications.",[32],[36],"Caplyta",{"type":31,"name":38,"description":39,"armGroupLabels":40},"Placebo","Subject will take placebo for 12 weeks, in addition to their regular medications.",[38],[42,46,49,53,56,59,62,65,68,71,74],{"measure":43,"description":44,"timeFrame":45},"Body Mass Index (BMI)","Participant Body Mass Index will be measured by standard methods","Week 0, Week 6, and Week 12",{"measure":47,"description":48,"timeFrame":45},"Waist Circumference","Participant Waist Circumference will be measured by standard methods",{"measure":50,"description":51,"timeFrame":52},"Body Composition - Fat Mass","Body Composition will be assessed using the research-grade medical body composition analyzer Seca 515\u002F514. Fat mass will be measured in grams.","Week 0 and Week 12",{"measure":54,"description":55,"timeFrame":52},"Body Composition - Total Body Mass","Body Composition will be assessed using the research-grade medical body composition analyzer Seca 515\u002F514. Total Body Mass will be measured in grams.",{"measure":57,"description":58,"timeFrame":52},"Body Composition - Fat Percentage","Body Composition will be assessed using the research-grade medical body composition analyzer Seca 515\u002F514. Fat Percentage will be calculated as fat mass (in grams) divided by total mass (in grams).",{"measure":60,"description":61,"timeFrame":52},"HBA1C","Participant HBA1C will be measured using standard labs",{"measure":63,"description":64,"timeFrame":45},"Fasting Insulin","Participant Fasting Insulin will be measured using standard labs",{"measure":66,"description":67,"timeFrame":52},"LDL Particle","LDL particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)",{"measure":69,"description":70,"timeFrame":52},"Small LDL Particle","Small LDL particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)",{"measure":72,"description":73,"timeFrame":52},"Large HDL Particle","Large HDL Particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)",{"measure":75,"description":76,"timeFrame":52},"Large VLDL Particle","Large VLDL Particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)",[78,81,84,87,90,93],{"measure":79,"description":80,"timeFrame":45},"Positive and Negative Symptoms Scale (PANSS)","PANSS is a measure used to assess symptom severity in patients with schizophrenia. It consists of three sections: Positive scale has 7 items, Negative scale has 7 items, and General Psychopathology has 16 items. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme.",{"measure":82,"description":83,"timeFrame":45},"Calgary Depression Scale (CDRS)","The CDRS is used to assess depression symptoms in patients with schizophrenia.",{"measure":85,"description":86,"timeFrame":45},"Clinical Global Impression - Severity Scale (CGI-S)","The CGI-S is an observer rated scale. The CGI-S measures illness severity on a 7-point Likert scale 1) Normal, not at all ill, 2) Borderline mentally ill, 3) Mildly ill, 4) Moderately ill, 5) Markedly ill, 6) Severely ill, and 7) Among the most extremely ill patient.",{"measure":88,"description":89,"timeFrame":45},"Clinical Global Impression - Improvement Scale (CGI-I)","The CGI-I is an observer rated scale. The CGI-I is used to measure improvement in illness and uses a 7-point Likert scale: 1) Very much improved, 2) Much improved, 3) Minimally improved, 4) No change 5) Minimally worse, 6) Much worse, 7) Very much worse.",{"measure":91,"description":92,"timeFrame":45},"Insomnia Severity Index (ISI)","The ISI is a 7-question survey assessing symptoms of insomnia. The maximum score is 28 with higher scores indicating greater severity. The ISI is a reliable and valid instrument to assess insomnia and treatment response.",{"measure":94,"description":95,"timeFrame":45},"Henrichs Carpenter Quality of Life Scale (QLS)","The QLS is a 21-item scale providing information on symptoms and functioning in patients with schizophrenia.","ALL","18 Years","65 Years",{"inclusion":100,"exclusion":106,"raw_text":115},[101,102,103,104,105],"Meets the DSM-5 criteria for diagnoses of schizophrenia or schizoaffective disorder based on the MINI International Neuropsychiatric Interview (MINI 7.0)","On clozapine treatment for at least 6 months","Stable dose of antipsychotic treatment for at least 1 month","Well established compliance with outpatient medications","Subjects of child-bearing potential are required to practice appropriate birth control methods during the study.",[107,108,109,110,111,112,113,114],"Psychiatrically unstable per clinical judgement by the principal investigator","Patients not on stable dose of antipsychotic medications","Currently meets DSM-5 criteria for any substance use disorder other than caffeine and nicotine","Significant, unstable medical conditions including severe cardiovascular, hepatic, renal or other medical diseases","History of a seizure disorder","Pregnancy or breastfeeding","On lumateperone treatment in the past 3 months","On a dopamine partial agonist antipsychotic agent in the past 3 months (aripiprazole, brexpiprazole, cariprazine)","Inclusion Criteria:\n\n* Meets the DSM-5 criteria for diagnoses of schizophrenia or schizoaffective disorder based on the MINI International Neuropsychiatric Interview (MINI 7.0)\n* On clozapine treatment for at least 6 months\n* Stable dose of antipsychotic treatment for at least 1 month\n* Well established compliance with outpatient medications\n* Subjects of child-bearing potential are required to practice appropriate birth control methods during the study.\n\nExclusion Criteria:\n\n* Psychiatrically unstable per clinical judgement by the principal investigator\n* Patients not on stable dose of antipsychotic medications\n* Currently meets DSM-5 criteria for any substance use disorder other than caffeine and nicotine\n* Significant, unstable medical conditions including severe cardiovascular, hepatic, renal or other medical diseases\n* History of a seizure disorder\n* Pregnancy or breastfeeding\n* On lumateperone treatment in the past 3 months\n* On a dopamine partial agonist antipsychotic agent in the past 3 months (aripiprazole, brexpiprazole, cariprazine)",[117,118],"ADULT","OLDER_ADULT",[120],{"facility":121,"status":7,"city":122,"state":123,"zip":124,"country":125,"contacts":126,"geoPoint":135},"UMass Chan Medical School","Worcester","Massachusetts","01655","United States",[127,132],{"name":128,"role":129,"phone":130,"email":131},"Abaigeal Grant","CONTACT","508-856-3027","abaigeal.grant2@umassmed.edu",{"name":133,"role":134},"Xiaoduo Fan, MD, MPH","PRINCIPAL_INVESTIGATOR",{"lat":136,"lon":137},42.26259,-71.80229,[139],{"name":140,"role":129,"phone":141,"email":131},"Abaigeal Grant, BA","5088563027",[143],{"name":144,"affiliation":121,"role":134},"Xiaoduo Fan, MD",[],[],{"nct_id":4,"conditions":148,"biomarkers":150},[149,18],"Schizoaffective Disorder",[],{"nct_id":4,"found":152,"summary":153,"prompt_version":163},true,{"design":154,"status":155,"heading":156,"summary":157,"follow_up":158,"word_count":159,"commitments":160,"compensation":161,"drugs_mentioned":162},"This is an interventional study with 50 planned participants. You will be randomly assigned to receive either lumateperone or a placebo in addition to your regular medication.","completed","Lumateperone for Metabolic Side Effects in Clozapine-Treated Schizophrenia","This study is looking into whether adding lumateperone (Caplyta) to your current clozapine medication can help reduce common side effects like weight gain and changes in blood sugar or cholesterol levels. You could be eligible if you are 18-65 years old, have schizophrenia or schizoaffective disorder, and have been taking clozapine for at least six months. Participants will be randomly assigned to take either lumateperone or a placebo (an inactive pill) for 12 weeks, in addition to their regular clozapine. Researchers will measure your Body Mass Index (BMI), waist size, and body fat to see if lumateperone helps. The study aims to enroll 50 participants, but its current status is unclear.","Your BMI and waist circumference will be measured at Week 0, Week 6, and Week 12. Body composition will be measured at Week 0 and Week 12.",111,"You will take either lumateperone or a placebo for 12 weeks. During this time, you will answer questions, have blood drawn, and have your body composition analyzed.","Not stated in the trial record.",[32,38],"v2"]