[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561448":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":18,"responsibleParty":35,"collaborators":18,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":18,"eligibilityCriteria":44,"healthyVolunteers":40,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":18,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":18,"overallStatus":59,"whyStopped":18,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":18},{"fullName":5,"class":6},"Universiti Putra Malaysia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","The intervention group will be added 5 mg of aripiprazole as an adjunct with the usual antipsychotic treatment to the females on antipsychotic treatment",[13],"Drug: Adjunctive Aripiprazole for improving Weight and Metabolic Outcomes in Females",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","No intervention will be given except usual antipsychotic treatment",null,[20],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":18},"DRUG","Adjunctive Aripiprazole for improving Weight and Metabolic Outcomes in Females",[9],[25],{"name":26,"affiliation":27,"role":28},"MUHAMMAD ARSHED, PhD","University of Lahore","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},"Sumbal Shehbaz, PhD","CONTACT","+92 331 4569159","sumbal.shahbaz@dhpt.uol.edu.pk",{"type":28,"investigatorFullName":36,"investigatorTitle":37,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Arshed Muhammad","PhD studentship","100561448","phase-4-evaluating-the-effects-of-adjunctive-aripiprazole-on-weight-and-metabolic-outcomes-in-females-100561448",false,"NCT06590298","Evaluating the Effects of Adjunctive Aripiprazole on Weight and Metabolic Outcomes in Females","Evaluating the Effects of Adjunctive Aripiprazole on Weight and Metabolic Outcomes in Females Receiving Atypical Antipsychotics: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Females aged 18-65 years diagnosed with a mental health condition necessitating antipsychotic treatment.\n* Diagnosis of Schizophrenia or Schizoaffective Disorder\n* On stable doses of atypical antipsychotics, either Olanzapine, Clozapine, or Risperidone for at least 1 month\n* Willingness to comply with the study protocol.\n\nExclusion Criteria:\n\n* Pregnancy or lactation.\n* Severe medical conditions impacting weight or metabolism.\n* Previous intolerance or contraindications to Aripiprazole.\n* Non-compliant with prescribed medications\n* Mental Retardation\n* Participant with an eating disorder\n* Participants with serious suicidal thoughts, or who pose a serious risk of harm to self or to others.\n* Diagnosis of Hyper or Hypothyroidism; Evidence of thyroid dysfunction as evidenced by serum thyroid function tests (i.e Thyroid Stimulating Hormone and -Free Thyroxine (fT4) levels \\> 10 % above or below the limits of the normal range Use of any medication for weight loss within the past one month to the study entry\n* Clinically significant abnormalities in physical examinations, ECG or lab assessments","FEMALE","18 Years","65 Years",{"count":49,"type":50},600,"ESTIMATED","INTERVENTIONAL",[53],"PHASE4","Patients with psychiatric disorders, including depression, anxiety, and schizophrenia, often require antipsychotic medications for symptom management. However, metabolic changes, especially weight gain, are a common and challenging side effect of many antipsychotics. Aripiprazole, an atypical antipsychotic, has shown promise in mitigating this adverse effect when used in combination with other antipsychotic medications.",[56,57,58],"Psychosis","Metabolic Syndrome","Weight Gain","NOT_YET_RECRUITING","2024-09-06",{"date":62,"type":63},"2024-09-19","ACTUAL",{"date":65,"type":50},"2024-09-15",{"date":67,"type":50},"2025-04-10",{"name":5,"class":6}]