NCT01255982已完成不适用
Functional Assessment of Patients With Acute Bipolar Depression After 8 Months of Follow-up
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
- 249
- 试验地点
- 1
- 主要终点
- Difference between basal and final Functional Assessment Staging (FAST) score to evaluate the functional change
研究概览
简要总结
This study aims to study prospectively for 8 months a sample of bipolar patients with acute depressive episode in order to identify that factors associated with functional impairment, with especial attention to the presence of subsyndromal symptoms beyond the acute phase.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Bipolar Disorder I or II (DSM-IV-TR)
- •Acute depressive episode at inclusion
排除标准
- •Inability (in investigator´s opinion) to carry out the follow-up plan
- •Patients participating or having participated within previous 6 months, in clinical trials
- •Mental retardation or any other medical condition affecting cognitive performance
结局指标
主要结局
Difference between basal and final Functional Assessment Staging (FAST) score to evaluate the functional change
时间窗: Range of Days 0-3
次要结局
- FAST score to estimate the proportion of patients that not achieve functional remission(Range of Days 0-3)
- Test Screen for Cognitive Impairment in Psychiatry (SCIP) to evaluate cognitive impairment both in the depressive phase and during clinical remission(Range of Days 0-3)
- Mood chart (self-report)(Range of Days 0-3)
- The presence of subsyndromal symptoms after the acute depressive phase using Montgomery-Asberg Depression Rating Scale (MADRS), Young Mania Rating Scale (YMRS), Diagnostic and Statistical Manual of Mental disorders (DSM-IV-TR)(Range of Days 0-3)
研究者
研究点 (1)
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