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)
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:
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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:
- monotherapy with the drug quetiapine
- combined antipsychotic therapy with quetiapine and aripiprazole
- combined antipsychotic therapy with quetiapine and haloperidol
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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:
- combined antipsychotic therapy with quetiapine and aripiprazole
- 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:
- First visit - baseline at which patient will be included in the study
- Second visit - 4 months after the baseline
- Third visit - 8 months after the baseline
- Fourth visit - 12 months after the baseline
研究概览
地位
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Halima Karakaš
- 电话号码：+38762478535
- 邮箱：HalimaK@Bosnalijek.ba
研究联系人备份
- 姓名：Una Glamoclija, PhD
- 电话号码：+38761147401
- 邮箱：UnaG@Bosnalijek.ba
学习地点
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-
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Sarajevo、波斯尼亚和黑塞哥维那、71000
- 招聘中
- Clinic of Psychiatry, University Clinical Center of Sarajevo
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接触：
- Gorana Sulejmanpašić, PhD
- 电话号码：+38733297359
- 邮箱：psihijatrija@kcus.ba
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Schizophrenia or bipolar affective disorder patients of both sexes aged 18 to 65 years.
描述
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
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Newly diagnosed patients
Newly diagnosed patients with a diagnosis of schizophrenia or bipolar affective disorder |
Monotherapy with the drug quetiapine Combined antipsychotic therapy with quetiapine and aripiprazole Combined antipsychotic therapy with quetiapine and haloperidol |
|
Previously diagnosed patients
Patients with a previous diagnosis of schizophrenia or bipolar affective disorder |
Combined antipsychotic therapy with quetiapine and aripiprazole Combined antipsychotic therapy with quetiapine and haloperidol |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Measurement of quality of life using the World Health Organization Quality of Life questionnaire (WHOQOL)-BREF
大体时间：12 months from inclusion into the study (baseline)
|
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). World Health Organization Quality of Life questionnaire (WHOQOL)-BREF will be used. It consists of 26 items that evaluate an individual's perception of their quality of life and consists of four domains: physical health (e.g., pain, energy, sleep, mobility, activities of daily living, work capacity); psychological health (e.g., positive and negative feelings, self-esteem, body image, cognition, spirituality); social relationships (e.g., personal relationships and social support) and environment. Domain scores are calculated according to the WHO scoring guidelines and can be transformed to a 0-100 scale, where higher scores represent a better quality of life. |
12 months from inclusion into the study (baseline)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
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
大体时间：12 months from baseline
|
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
|
|
Therapy adherence using the Medication Adherence Rating Scale (MARS)
大体时间：12 months from baseline
|
Medication Adherence Rating Scale (MARS), a validated self-report questionnaire designed to evaluate patients' adherence to prescribed medication regimens. The instrument was originally developed for patients receiving long-term pharmacological treatment and has been widely used in studies of psychiatric and chronic medical conditions. The MARS consists of 10 items that assess both medication-taking behavior and patients' attitudes toward medication, including forgetfulness, intentional omission of doses, discontinuation of treatment when feeling better or worse, and beliefs regarding the effects of medication. Responses are provided in a dichotomous (Yes/No) format. Individual item scores are summed to obtain a total score ranging from 0 to 10, with higher scores indicating better medication adherence. The scale enables the identification of both intentional and unintentional non-adherence and provides insight into factors affecting treatment adherence. |
12 months from baseline
|
合作者和调查者
调查人员
- 首席研究员：Gorana Sulejmanpašić, PhD、Clinic of Psychiatry, University Clinical Center of Sarajevo
- 首席研究员：Amra Memić Serdarević, PhD、Clinic of Psychiatry, University Clinical Center of Sarajevo
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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