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临床试验/NCT00690248
NCT00690248已完成不适用

Prevalence of Depressive Symptoms in Manic Episodes of Bipolar Patients: an Observational Study

AstraZeneca1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2007年11月最近更新:
适应症

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

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)

研究者

发起方
AstraZeneca
申办方类型
Industry

研究点 (1)

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