Prospective Comparative Study to Estimate the Prevalence of Depression in Type2 Diabetes Patients in a Tertiary Care Centre
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- PRIMARY-Presence of depression in both the case and control (non-diabetic) groups at the time of assessment.
研究概览
简要总结
The Primary purpose of the study is to estimate the prevalence of clinically relevant depression in type 2 diabetic patients as compared to non-diabetic group. and to to determine the relation of depression with glycemic control and also to determine the association of depression with co-morbid complications of T2DM.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
The hypothesis being tested is:
H0: pT = pC vs. H1: pT ≠pC
Where pT and pC are the proportion of depression in diabetes and non diabetes groups respectively, rejection of the null hypothesis at a two sided significance level of 0.05 indicates a significant difference between two arms.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •CASE GROUP •Patients having diagnosis of type 2 diabetes as defined by American Diabetes Association (ADA 2011) criteria.
- •â€¢Patients with absence of diagnosis of depression/anxiety before the diagnosis of DM.
- •CONTROL GROUP •Absence of diagnosed type 2 diabetes mellitus as defined by ADA criteria (2011).
排除标准
- •CASE GROUP •Associated drug and alcohol dependence.
- •â€¢Presence of organic illness associated with depression.
- •â€¢Any other major psychiatric illness, like Schizophrenia and mental retardation.
- •â€¢Patients with severe cognitive impairment.
- •â€¢Patient already on any psychotropic drug.
结局指标
主要结局
PRIMARY-Presence of depression in both the case and control (non-diabetic) groups at the time of assessment.
时间窗: 2 months
次要结局
- SECONDARY-(1.Higher depression score in case of poor glycemic control.)