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Recruiting NCT07858565

Quality of Life, Safety and Compliance of Patients Using Monotherapy or Combinatorial Therapy With Quetiapine for Treatment of Schizophrenia or Bipolar Affective Disorder

Conditions: Schizophrenia, Bipolar Affective Disorder

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Enrollment: 500
Sponsor: Bosnalijek D.D

Location: Clinic of Psychiatry, University Clinical Center of Sarajevo Sarajevo

Summary

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/antipsychotics. The main outcome measures are: * quality of life using the World Health Organization Quality of Life questionnaire (WHOQOL) * 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 * therapy adherence using the Medication Adherence Rating Scale (MARS). The subjects will be divided into two groups: 1. 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: 1. monotherapy with the drug quetiapine 2. combined antipsychotic therapy with quetiapine and aripiprazole 3. combined antipsychotic therapy with quetiapine and haloperidol 2. 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: 1. combined antipsychotic therapy with quetiapine and aripiprazole 2. combined antipsychotic therapy with quetiapine and haloperidol Recruitment of subjects will be carried out by physicians/researchers 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). Patients will have four visits to physician/researcher: 1. First visit - baseline at which patient will be included in the study 2. Second visit - 4 months after the baseline 3. Third visit - 8 months after the baseline 4. Fourth visit - 12 months after the baseline

Eligibility Criteria

Inclusion Criteria: * Persons over 18 years of age and under 65 years of age. * Schizophrenia or bipolar affective disorder established by the usual diagnostic criteria applied in a psychiatric clinic or hospital ward/unit within the clinic or outpatient. * Patients who are treated as outpatients, inpatients or have been discharged from the clinic/hospital with a recommendation for quetiapine monotherapy or combination therapy of quetiapine with aripiprazole or haloperidol. Recommended by a specialist psychiatrist/neuropsychiatrist in clinical and hospital centers and through specialist-consultant outpatient clinics in Bosnia and Herzegovina. Exclusion Criteria: * Persons younger than 18 years and older than 65 years * Hypersensitivity to the components of the drug * Positive history of angioneurotic edema * Pregnancy * Breastfeeding * Simultaneous use with cytochrome P450 3A4 inhibitors, such as HIV-protease inhibitors, azole antifungals, erythromycin, clarithromycin and nefazodone * Patients who are planning to become pregnant in the near future * Diagnosed medical conditions that may constitute a contraindication for the use of the drug quetiapine Withdrawal Criteria: * Deterioration of the underlying disease that requires therapy discontinuation * Development of serious adverse events requiring therapy discontinuation * Occurence of pregnancy * Development of another disease that affects the course of the study

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07858565). StuddyBuddy aggregates publicly available trial information.