First choIce Antidepressants: General Practitioner's Treatment Approach in the Czech Republic (FIAT)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 6
- 主要终点
- Description of the dose of the antidepressant
研究概览
简要总结
According to the local guidelines (Recommendation for General Practitioners), the first choice Anti-Depressant (AD) in Major Depressive Disorder (MDD) in primary care should be selective serotonin reuptake inhibitors (SSRI), e.g. citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, in depression with anxiety and insomnia is preferable trazodone and in severer disorders mirtazapine. Despite all these molecules have a very good antidepressant effect, there are differences in side effect scale and tolerability.
The aim of this Study is describing of real treatment practice and MDD management in primary care - aimed to evaluate effectiveness of the treatments in depression and related symptoms: insomnia, anxiety, anhedonia and sexual dysfunction.
The primary objective of the Study is to describe the diagnostic process and treatment patterns in MDD- treatment of choice (pharmacologic with details of first choice antidepressant) in the office of GP's.
The secondary objective is to evaluate efficiency of the treatments in depression and related symptoms: insomnia, anxiety, anhedonia and sexual dysfunction and to monitor the type of side effects and comedication during the 8-weeks treatment.
详细描述
Research question:
What are the common clinical practices adopted by general practitioner - diagnostic process and treatment of choice (pharmacologic with details of first choice antidepressant) in patients with newly diagnosed depression and how the diagnosis is performed.
Data sources:
Validated questionnaires (PHQ-9, GAD-7, SHAPS), quality of sleep measures with wrist actigraphy monitor. Questions dedicated to sexual dysfunctions. Data about patient's history, diagnosis, treatment and relevant side effects collected directly to the database.
Variables:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signing of the Inform Consent Form (Personal Data Protection Consent included)
- •Adults male and female newly diagnosed with depression in care of the general practitioner
排除标准
- •Patients previously treated with depression or patients treated by a psychiatrist
- •Pregnancy and breast-feeding
- •Acute myocardial infarction
- •Significant risk of suicide
- •Concomitant antidepressant medication
结局指标
主要结局
Description of the dose of the antidepressant
时间窗: patient duration: from enrollment to end of treatment for 8 weeks
The difference between the therapeutic and prescribed dose of antidepressant will be computed as therapeutic dose - prescribed dose.
Description of the increase of dose
时间窗: patient duration: from enrollment to end of treatment for 8 weeks
The variable the increase of dose will be computed as changes of dose of comedication drug at the end of follow-up - dose of the drug at the start of follow-up.
Description of the maximum daily dose of antidepressant
时间窗: patient duration: from enrollment to end of treatment for 8 weeks
The variable maximum total daily dose will be observed and evaluated.
Description of the type of antidepressant
时间窗: patient duration: from enrollment to end of treatment for 8 weeks
The variable type of antidepressant will be observed and evaluated.
Description of the time on an antidepressant without change of dose
时间窗: patient duration: from enrollment to end of treatment for 8 weeks
Time on an antidepressant without change of dose will be computed as date of increase of dose - date of enrolment visit.
次要结局
- Treatment efficiency - level of depression(patient duration: from enrollment to end of treatment for 8 weeks)
- Treatment efficiency - adverse events(patient duration: from enrollment to end of treatment for 8 weeks)
- Treatment efficiency - insomnia - change in total sleep time(patient duration: from enrollment to end of treatment for 8 weeks)
- Treatment efficiency - anhedonia(patient duration: from enrollment to end of treatment for 8 weeks)
- Treatment efficiency - insomnia - sleep efficiency(patient duration: from enrollment to end of treatment for 8 weeks)
- Treatment efficiency - insomnia - sleep latency(patient duration: from enrollment to end of treatment for 8 weeks)
- Treatment efficiency - insomnia - sleep fragmentation index(patient duration: from enrollment to end of treatment for 8 weeks)
- Treatment efficiency - insomnia - sleep bouts(patient duration: from enrollment to end of treatment for 8 weeks)
- Treatment efficiency - anxiety(patient duration: from enrollment to end of treatment for 8 weeks)
- Treatment efficiency - sexual dysfunction(patient duration: from enrollment to end of treatment for 8 weeks)
- Monitoring of the type of comedication during the 8-weeks(patient duration: from enrollment to end of treatment for 8 weeks)