CTRI/2018/09/015861已完成不适用
Multicenter, Noninterventional, Cross-sectional Study to Evaluate the Clinical Characteristics, Sociodemographic Profile, and Treatment Patterns in Patients with Bipolar Disorder in India
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 33
- 主要终点
- 1. Description of detailed illness pattern of BPD
研究概览
简要总结
This is a Multicenter, Noninterventional, Cross-sectional Study to understand the Clinical Characteristics, Sociodemographic Profile, and Treatment Patterns in Patients with Bipolar Disorder in India. This study neither involve drug nor it involves any intervention.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female patients aged between 18 and 65 years
- •Patients who are able to read and write
- •Patients diagnosed with BPD type I or II per DSM-5 criteria, with a duration of at least 2 years
- •Patients and family care giver/legally acceptable representative (LAR) who are willing and competent to sign and date a patient authorization form (PAF) for participation in the study.
排除标准
- •Patients with a diagnosis of any schizophrenia spectrum disorder after the diagnosis of BPD
- •Patients with mental disorders of organic origin.
- •Patients with any condition that in the opinion of the investigator makes the patient unsuitable for inclusion based on clinical judgment.
结局指标
主要结局
1. Description of detailed illness pattern of BPD
时间窗: 1
2. Description of detailed pharmacological treatments
时间窗: 1
次要结局
- 1. Description of sociodemographic and clinical factors associated with BPD(2. Functional impairment as assessed by WHO DAS 2.0, 12-Item version)
研究者
研究点 (33)
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