Clinical Research Directory

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

Sponsor: Bosnalijek D.D

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

Official title: 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)

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