[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619295":3},{"organization":4,"outcomesModule":7,"designInfo":47,"detailedDescription":56,"studyPopulation":50,"armGroups":57,"interventions":69,"overallOfficials":81,"centralContacts":85,"locations":91,"responsibleParty":116,"collaborators":50,"id":119,"slug":120,"hasResults":121,"nctId":122,"briefTitle":123,"officialTitle":123,"acronym":50,"eligibilityCriteria":124,"healthyVolunteers":121,"sex":125,"minAge":126,"maxAge":127,"enrollmentInfo":128,"targetDuration":50,"studyType":131,"phases":132,"briefSummary":134,"conditions":135,"keywords":138,"overallStatus":146,"whyStopped":50,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},{"fullName":5,"class":6},"Sultan Qaboos University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":43},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Body Weight","Change in body weight from baseline to the primary endpoint. Body weight will be measured using standardized procedures and compared between the dapagliflozin plus common lifestyle program arm and the metformin plus common lifestyle program arm.","Baseline, Week 12, and Week 26 at the maximum tolerated dose",[14,18,21,24,27,30,33,36,40],{"measure":15,"description":16,"timeFrame":17},"Change in Body Mass Index (BMI)","Change in BMI (kg\u002Fm²) from baseline to week 26 to evaluate overall body composition changes associated with each intervention.","Baseline, Week 12, and Week 26",{"measure":19,"description":20,"timeFrame":17},"Change in Waist Circumference","Change in waist circumference (measured at the midpoint between the lowest rib and iliac crest) from baseline to week 26, assessing central fat distribution.",{"measure":22,"description":23,"timeFrame":17},"Change in Fasting Plasma Glucose","Difference in fasting plasma glucose levels from baseline to week 26, reflecting glucose metabolism and glycemic control.",{"measure":25,"description":26,"timeFrame":17},"Change in Glycated Hemoglobin (HbA1c)","Change in HbA1c (%) from baseline to week 26, assessing long-term glucose regulation.",{"measure":28,"description":29,"timeFrame":17},"Change in Lipid Profile","Change in total cholesterol, LDL, HDL, and triglycerides from baseline to week 26, evaluating metabolic health and cardiovascular risk.",{"measure":31,"description":32,"timeFrame":17},"Change in psychiatric symptom severity","* Psychotic symptom severity will be assessed using the Brief Psychiatric Rating Scale, an 18-item clinician-rated scale. Total scores range from 18 to 126, with higher scores indicating greater psychotic symptom severity.\n* Depressive symptom severity will be assessed using the 17-item Hamilton Depression Rating Scale. Total scores range from 0 to 52, with higher scores indicating greater depressive symptom severity.\n* Manic symptom severity will be assessed using the Young Mania Rating Scale, an 11-item clinician-rated scale. Total scores range from 0 to 60, with higher scores indicating greater manic symptom severity.\n* Obsessive-compulsive symptom severity will be assessed using the Yale-Brown Obsessive Compulsive Scale. Total scores range from 0 to 40, with higher scores indicating greater obsessive-compulsive symptom severity.",{"measure":34,"description":35,"timeFrame":17},"Change in quality of life","Change in health-related quality of life assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L).",{"measure":37,"description":38,"timeFrame":39},"Medication adherence","Assessment of participant adherence to the assigned intervention during scheduled visits and telephone follow-up.","Week 2, Week 6, Week 12, Week 18, and Week 26",{"measure":41,"description":42,"timeFrame":39},"Adverse events and tolerability","Frequency, severity, duration, action taken, and outcome of adverse events and tolerability issues reported during the study period.",[44],{"measure":45,"description":46,"timeFrame":17},"Physical activity assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF)","Self-reported physical activity will be assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). Physical activity will be measured to describe participant activity levels and to support adjustment for physical activity as a potential confounding variable in analyses of body weight and metabolic outcomes.",{"allocation":48,"interventionModel":49,"interventionModelDescription":50,"primaryPurpose":51,"observationalModel":50,"timePerspective":50,"maskingInfo":52},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":53,"maskingDescription":50,"whoMasked":54},"SINGLE",[55],"OUTCOMES_ASSESSOR","This is an open-label, pragmatic, parallel-group pilot randomized controlled trial comparing dapagliflozin with metformin for the management of antipsychotic-induced weight gain. The study will be conducted at the Department of Behavioral Medicine, Sultan Qaboos University Hospital, University Medical City, Muscat, Oman.\n\nAntipsychotic-induced weight gain is a common and clinically important adverse effect of antipsychotic treatment. It may contribute to reduced treatment adherence, poorer quality of life, and increased cardiometabolic risk. Metformin is commonly used to manage antipsychotic-associated weight gain, but its use may be limited by gastrointestinal adverse effects, dose titration, and pill burden. Dapagliflozin, a sodium-glucose cotransporter 2 inhibitor, has demonstrated weight-reducing and metabolic benefits in other clinical populations, but its role in antipsychotic-induced weight gain remains insufficiently studied.\n\nParticipants will be randomized in a 1:1 ratio to receive either dapagliflozin plus a common lifestyle program or metformin plus a common lifestyle program. The trial will use a pragmatic PROBE-style design, with open-label treatment allocation and blinded outcome assessment and statistical analysis where feasible. Randomization will use a computer-generated sequence with allocation concealment.\n\nThe study is designed as a pilot trial to assess feasibility, tolerability, adherence, safety, and preliminary estimates of treatment effect to inform a future definitive trial. Standardized procedures will be used for participant follow-up, medication review, safety monitoring, and data collection. Adverse events and treatment tolerability will be monitored throughout the study, and serious adverse events will be reported according to institutional and ethics committee procedures.\n\nData will be collected by trained study personnel and entered into an electronic database with procedures to support completeness and accuracy. Analyses will be primarily descriptive and exploratory, consistent with the pilot nature of the trial, and will be used to refine assumptions for a future larger randomized controlled trial.",[58,64],{"label":59,"type":60,"description":50,"interventionNames":61},"Metformin","ACTIVE_COMPARATOR",[62,63],"Drug: Metformin","Other: Common Lifestyle Program",{"label":65,"type":66,"description":50,"interventionNames":67},"Dapagliflozin","EXPERIMENTAL",[68,63],"Drug: Dapagliflozin",[70,74,77],{"type":71,"name":65,"description":72,"armGroupLabels":73,"otherNames":50},"DRUG","Dapagliflozin will be administered orally at a dose of 10 mg once daily. Treatment will continue for 26 weeks. Participants will be monitored for adherence, tolerability, and adverse events, including genitourinary symptoms, dehydration, sick-day events, and symptoms suggestive of ketoacidosis.",[65],{"type":71,"name":59,"description":75,"armGroupLabels":76,"otherNames":50},"Metformin will be administered orally. Participants will start with 500 mg twice daily, taken with meals, and will be titrated to 1000 mg twice daily by the second week as tolerated. Slower titration may be used if gastrointestinal side effects occur. Treatment will continue for the study period, with the primary endpoint assessed after 26 weeks at the maximum tolerated dose.",[59],{"type":6,"name":78,"description":79,"armGroupLabels":80,"otherNames":50},"Common Lifestyle Program","All participants will receive a standardized common lifestyle program. This will include dietary counselling, physical activity counselling, and behavioural support delivered at baseline and reinforced during scheduled in-person visits and telephone follow-up. Physical activity will be assessed using the International Physical Activity Questionnaire.",[65,59],[82],{"name":83,"affiliation":5,"role":84},"Mohammed Al Alawi, MD, PhD","STUDY_CHAIR",[86],{"name":87,"role":88,"phone":89,"phoneExt":50,"email":90},"Said A Al Farsi, MD","CONTACT","00968 95783006","said.alfarsi96@gmail.com",[92],{"facility":93,"status":50,"city":94,"state":50,"zip":50,"country":95,"countryCode":96,"cosmosGeoPoint":97,"geoPoint":102,"contacts":103},"SQU","Muscat","Oman","OM",{"type":98,"coordinates":99},"Point",[100,101],58.40778,23.58413,{"lat":101,"lon":100},[104,107,109,112,114],{"name":83,"role":88,"phone":105,"phoneExt":50,"email":106},"00968 92291145","m.alalawi2@squ.edu.om",{"name":83,"role":108,"phone":50,"phoneExt":50,"email":50},"PRINCIPAL_INVESTIGATOR",{"name":110,"role":111,"phone":50,"phoneExt":50,"email":50},"Said Al Farsi, MD","SUB_INVESTIGATOR",{"name":113,"role":111,"phone":50,"phoneExt":50,"email":50},"Ghadeer Al Nuaimi, MD",{"name":115,"role":111,"phone":50,"phoneExt":50,"email":50},"Merah Al Busaidi, MD",{"type":108,"investigatorFullName":117,"investigatorTitle":118,"investigatorAffiliation":5,"oldNameTitle":50,"oldOrganization":50},"Mohammed Al Alawi MD PhD MRCPsych ARABpsych OMSBpsych","Consultant and Assistant Professor","100619295","phase-4-dapagliflozin-versus-metformin-for-the-management-of-antipsychotic-induced-weight-gain-a-pragmatic-pilot-randomized-controlled-trial-100619295",false,"NCT07342764","Dapagliflozin Versus Metformin for the Management of Antipsychotic-Induced Weight Gain: A Pragmatic Pilot Randomized Controlled Trial","Inclusion criteria:\n\n* Patients aged ≥16 years\n* Diagnosis according to DSM-5 criteria, including:\n\nSchizophrenia spectrum and other psychotic disorders, as summarized in the DSM-5 chapter Schizophrenia Spectrum and Other Psychotic Disorders, excluding:\n\nSubstance\u002Fmedication-induced psychotic disorder Psychotic disorder due to another medical condition Catatonia associated with another mental disorder Catatonic disorder due to another medical condition Unspecified catatonia Bipolar and related disorders, as summarized in the DSM-5 chapter Bipolar and Related Disorders Depressive disorders, as summarized in the DSM-5 chapter Depressive Disorders Obsessive-compulsive and related disorders, as summarized in the DSM-5 chapter Obsessive-Compulsive and Related Disorders Other psychiatric conditions for which antipsychotic treatment is clinically indicated, as judged by the investigator Other conditions where antipsychotics are indicated\n\n* Receiving stable antipsychotic treatment for ≥3 months prior to enrollment\n* Evidence of antipsychotic-induced weight gain (AiWG), defined as:\n\n  1. ≥7% increase in body weight from baseline following initiation of antipsychotic treatment, or\n  2. BMI \\>25 kg\u002Fm² with clinically established antipsychotic-associated weight gain\n* Able to understand and comply with study procedures, as judged by the investigator\n* Able to provide written informed consent. For participants aged 16-17 years, assent and\u002For guardian consent will be obtained according to local ethics committee requirements.\n\nExclusion criteria:\n\n* Diabetes mellitus\n* Diagnosed patients of polycystic ovarian syndrome (PCOS)\n* Renal impairment defined as estimated glomerular filtration rate (eGFR \\\u003C45 mL\u002Fmin\u002F1.73 m²)\n* Significant hepatic disease or other serious or unstable medical conditions that, in the opinion of the investigator, would make participation unsafe\n* Pregnant or breastfeeding females\n* Current use of metformin, dapagliflozin, or another sodium-glucose cotransporter 2 inhibitor.\n* Use of weight-loss medications or participation in structured weight-loss programs within the past 3 months\n* Recurrent genitourinary infections (if dapagliflozin is used)\n* Use of non-antipsychotic medications known to cause clinically significant weight gain, including but not limited to selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), mirtazapine, tricyclic antidepressants, valproate, lithium, corticosteroids, sedating antihistamines, or other medications as judged by the investigator\n* Unstable psychiatric condition or active substance use disorder that may impair the ability to adhere to study procedures, as judged by the investigator","ALL","16 Years","60 Years",{"count":129,"type":130},110,"ESTIMATED","INTERVENTIONAL",[133],"PHASE4","The goal of this clinical trial is to learn whether dapagliflozin can help manage weight gain caused by antipsychotic medications in people aged 16 years or older who are receiving antipsychotic treatment and have developed antipsychotic-induced weight gain.\n\nThe main questions it aims to answer are:\n\nCan dapagliflozin reduce body weight as effectively and safely as metformin over the study period?\n\nHow do dapagliflozin and metformin compare in their effects on body weight, body mass index, waist circumference, blood sugar, HbA1c, lipid profile, psychiatric symptoms, quality of life, medication adherence, and side effects?\n\nResearchers will compare dapagliflozin plus a common lifestyle program with metformin plus a common lifestyle program to see which treatment is more effective, better tolerated, and more acceptable for managing antipsychotic-induced weight gain.\n\nParticipants will:\n\nBe randomly assigned to receive either dapagliflozin or metformin. Receive lifestyle advice, including dietary counselling, physical activity counselling, and behavioural support.\n\nAttend clinic visits at baseline, Week 12, and Week 26 for weight, waist circumference, blood tests, medication review, and other assessments.\n\nReceive telephone follow-up at Week 2, Week 6, and Week 18 to check medication adherence, side effects, tolerability, and lifestyle progress.\n\nComplete questionnaires and clinical assessments related to physical activity, quality of life, psychiatric symptoms, and treatment tolerability.",[136,137],"Antipsychotic-induced Weight Gain (AIWG)","Antipsychotic-induced Weight Gain",[65,59,139,140,141,142,143,144,145],"Antipsychotic-induced weight gain","Psychotic disorders","Randomized controlled trial","Weight management","Metabolic side effects","Lifestyle intervention","SGLT2 inhibitor","NOT_YET_RECRUITING","2026-06-06",{"date":149,"type":150},"2026-06-10","ACTUAL",{"date":152,"type":130},"2026-09",{"date":154,"type":130},"2028-12",{"name":5,"class":6},1]