[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658899":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":20,"studyPopulation":24,"armGroups":25,"interventions":37,"overallOfficials":51,"centralContacts":58,"locations":68,"responsibleParty":85,"collaborators":20,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":20,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":20,"studyType":100,"phases":20,"briefSummary":101,"conditions":102,"keywords":20,"overallStatus":70,"whyStopped":20,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Bosnalijek D.D","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Measurement of quality of life using the World Health Organization Quality of Life questionnaire (WHOQOL)","Evaluation of the quality of life of patients during treatment for schizophrenia or bipolar affective disorder using monotherapy with the drug quetiapine or combination therapy with the drug quetiapine and another antipsychotic (aripiprazole or haloperidol).","12 months from inclusion into the study (baseline)",[14,18],{"measure":15,"description":16,"timeFrame":17},"Safety assessment through incidence of possible adverse drug events and evaluation of the association between the administration of the drug and the occurrence of an adverse reaction","Safety through the monitoring of the incidence of possible adverse drug events by the researcher, with the assessment of the association between the administration of the drug and the occurrence of an adverse reaction","12 months from baseline",{"measure":19,"description":20,"timeFrame":17},"Therapy adherence using the Medication Adherence Rating Scale (MARS)",null,{"allocation":20,"interventionModel":20,"interventionModelDescription":20,"primaryPurpose":20,"observationalModel":22,"timePerspective":23,"maskingInfo":20},"COHORT","PROSPECTIVE","Schizophrenia or bipolar affective disorder patients of both sexes aged 18 to 65 years.",[26,33],{"label":27,"type":20,"description":28,"interventionNames":29},"Newly diagnosed patients","Newly diagnosed patients with a diagnosis of schizophrenia or bipolar affective disorder",[30,31,32],"Drug: Quetiapine (drug)","Drug: quetiapine + aripiprazole","Drug: quetiapine + haloperidol",{"label":34,"type":20,"description":35,"interventionNames":36},"Previously diagnosed patients","Patients with a previous diagnosis of schizophrenia or bipolar affective disorder",[31,32],[38,43,47],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":20},"DRUG","Quetiapine (drug)","Monotherapy with the drug quetiapine",[27],{"type":39,"name":44,"description":45,"armGroupLabels":46,"otherNames":20},"quetiapine + aripiprazole","Combined antipsychotic therapy with quetiapine and aripiprazole",[27,34],{"type":39,"name":48,"description":49,"armGroupLabels":50,"otherNames":20},"quetiapine + haloperidol","Combined antipsychotic therapy with quetiapine and haloperidol",[27,34],[52,56],{"name":53,"affiliation":54,"role":55},"Gorana Sulejmanpašić, PhD","Clinic of Psychiatry, University Clinical Center of Sarajevo","PRINCIPAL_INVESTIGATOR",{"name":57,"affiliation":54,"role":55},"Amra Memić Serdarević, PhD",[59,64],{"name":60,"role":61,"phone":62,"phoneExt":20,"email":63},"Halima Karakaš","CONTACT","+38762478535","HalimaK@Bosnalijek.ba",{"name":65,"role":61,"phone":66,"phoneExt":20,"email":67},"Una Glamoclija, PhD","+38761147401","UnaG@Bosnalijek.ba",[69],{"facility":54,"status":70,"city":71,"state":20,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"RECRUITING","Sarajevo","71000","Bosnia and Herzegovina","BA",{"type":76,"coordinates":77},"Point",[78,79],18.35644,43.84864,{"lat":79,"lon":78},[82],{"name":53,"role":61,"phone":83,"phoneExt":20,"email":84},"+38733297359","psihijatrija@kcus.ba",{"type":86,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100658899","quality-of-life-safety-and-compliance-of-patients-using-monotherapy-or-combinatorial-therapy-with-quetiapine-for-treatment-of-schizophrenia-or-bipolar-affective-disorder-100658899",false,"NCT07858565","Quality of Life, Safety and Compliance of Patients Using Monotherapy or Combinatorial Therapy With Quetiapine for Treatment of Schizophrenia or Bipolar Affective Disorder","Study of Quality of Life, Safety and Compliance During Treatment of Schizophrenia or Bipolar Affective Disorder, in Patients Using the Drug Kvepin® (Quetiapine) as Monotherapy or Combination Therapy With Other Antipsychotics (Ispitivanje Kvalitete života, Sigurnosti i Saradljivosti u Toku liječenja Shizofrenije Ili Bipolarnog Afektivnog poremećaja, Kod Pacijenata Koji Koriste Lijek Kvepin® (Kvetiapin) Kao Monoterapiju Ili Kombinovanu Terapiju sa Drugim Antipsihoticima)","Inclusion Criteria:\n\n* Persons over 18 years of age and under 65 years of age.\n* Schizophrenia or bipolar affective disorder established by the usual diagnostic criteria applied in a psychiatric clinic or hospital ward\u002Funit within the clinic or outpatient.\n* Patients who are treated as outpatients, inpatients or have been discharged from the clinic\u002Fhospital with a recommendation for quetiapine monotherapy or combination therapy of quetiapine with aripiprazole or haloperidol. Recommended by a specialist psychiatrist\u002Fneuropsychiatrist in clinical and hospital centers and through specialist-consultant outpatient clinics in Bosnia and Herzegovina.\n\nExclusion Criteria:\n\n* Persons younger than 18 years and older than 65 years\n* Hypersensitivity to the components of the drug\n* Positive history of angioneurotic edema\n* Pregnancy\n* Breastfeeding\n* Simultaneous use with cytochrome P450 3A4 inhibitors, such as HIV-protease inhibitors, azole antifungals, erythromycin, clarithromycin and nefazodone\n* Patients who are planning to become pregnant in the near future\n* Diagnosed medical conditions that may constitute a contraindication for the use of the drug quetiapine\n\nWithdrawal Criteria:\n\n* Deterioration of the underlying disease that requires therapy discontinuation\n* Development of serious adverse events requiring therapy discontinuation\n* Occurence of pregnancy\n* Development of another disease that affects the course of the study","ALL","18 Years","65 Years",{"count":98,"type":99},500,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to evaluate the quality of life, drug safety and therapy compliance of schizophrenia or bipolar affective disorder patients during the treatment with quetiapine monotherapy or in combination with another antipsychotic\u002Fantipsychotics. The main outcome measures are:\n\n* quality of life using the World Health Organization Quality of Life questionnaire (WHOQOL)\n* safety through the monitoring of the incidence of possible adverse drug events by the researcher, with the assessment of the association between the administration of the drug and the occurrence of an adverse reaction\n* therapy adherence using the Medication Adherence Rating Scale (MARS).\n\nThe subjects will be divided into two groups:\n\n1. Newly diagnosed patients with a diagnosis of schizophrenia or bipolar affective disorder whose individual therapeutic approach, based on the clinical assessment of the research physician, includes one of the following therapies:\n\n   1. monotherapy with the drug quetiapine\n   2. combined antipsychotic therapy with quetiapine and aripiprazole\n   3. combined antipsychotic therapy with quetiapine and haloperidol\n2. Patients with a diagnosis of schizophrenia or bipolar affective disorder who are on therapy with one of the antipsychotics (aripiprazole or haloperidol), and who, based on the clinical assessment of the investigator, require adjunctive quetiapine therapy. This group will include two subgroups of patients:\n\n   1. combined antipsychotic therapy with quetiapine and aripiprazole\n   2. combined antipsychotic therapy with quetiapine and haloperidol Recruitment of subjects will be carried out by physicians\u002Fresearchers based on the patient's history and diagnosis. The diagnosis of schizophrenia or bipolar affective disorder will be based on the standard diagnostic criteria in medical practice (validated measurement scales in psychiatry - Young's Mania Scale, Beck Depression Scale and PANNS Schizophrenia Scale).\n\nPatients will have four visits to physician\u002Fresearcher:\n\n1. First visit - baseline at which patient will be included in the study\n2. Second visit - 4 months after the baseline\n3. Third visit - 8 months after the baseline\n4. Fourth visit - 12 months after the baseline",[103,104],"Schizophrenia","Bipolar Affective Disorder","2026-09-29",{"date":107,"type":108},"2026-10-05","ACTUAL",{"date":110,"type":108},"2025-10-30",{"date":112,"type":99},"2027-05",{"name":5,"class":6},1]