Prevalence of Depressive Symptoms in Manic Episodes of Bipolar Patients: an Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Score of the MADRS (Montgomery-Asberg Depression Rating Scale) in bipolar patients with acute mania.
研究概览
简要总结
Observational, non-interventional, transversal, multicenter, open label (No treatment is involved). The primary objective is to detect the prevalence of depressive symptoms in bipolar patients admitted to a psychiatric Unit due to an acute mania episode. Secondary objectives include 1) to evaluate, the relationship between depressive symptoms and severity of mania; 2) to evaluate, the relationship between depressive symptoms and anxiety; 3) to evaluate, the relationship between depressive symptoms and psychotic symptoms; 4) to evaluate, the relationship between depressive symptoms and insight; 5) to evaluate, the relationship between depressive symptoms and clinical global impression; 6) to evaluate, the relationship between depressive symptoms and previous treatment with antipsychotics (whatever the antipsychotic was); 7) to evaluate, the relationship between depressive symptoms and length of admission; 8) to evaluate factors (demographic, evolution...) which could be involved in the presence of depressive symptoms within an acute manic episode; 9) to evaluate, the difference on the initial prescription due to the detection of depressive symptoms; 10) to evaluate, if exists, differences on the previous psychiatric diagnosis in patients with and without depressive symptoms. The primary endpoint is score of the MADRS (Montgomery-Asberg Depression Rating Scale) in bipolar patients with acute mania
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed of Bipolar Disorder based on DSM-IV-TR
- •Patients admitted to an acute inpatient psychiatric Unit due to an acute manic episode (as defined in DSM-IV_TR)
- •Provision of written informed consent.
- •Total score in Young Mania Rating Scale >=20
- •Able to understand and comply with the requirements of the study
排除标准
- •Mental retardation
- •Patients with manic symptoms are due to substance use, based in the investigator opinion
- •Patients with unstable organic diseases, who are not receiving adequate treatment, according the investigator opinion.
- •Participation in a trial with drugs within 4 weeks of enrolment into this study.
结局指标
主要结局
Score of the MADRS (Montgomery-Asberg Depression Rating Scale) in bipolar patients with acute mania.
时间窗: once during study
次要结局
- Anxiety symptoms measures with HARS (Hamilton Anxiety Rating Scale).(once during study)
- Hamilton Depression Rating Scale (5 items)(once during study)
- Mania symptoms measured with YMRS (Young Mania Rating Scale).(once during study)
- Scale of Unawareness of Mental Disorders (SUMD)(once during study)
- Days of hospitalization, MADRS (6 items)(once during study)
- Psychotic symptoms measured with BPRS (Brief Psychosis Rating Scale).(once during study)
- Clinical status and improvement measured with CGI-BP (Clinical Global Impression - Bipolar scale).(once during study)
