A Study to Estimate the Prevalence of Depression in Type2 Diabetes Patients as compared to non-diabetic patients in a Tertiary Care Centre

Completed

• Conditions: Prevelance of depression in Type 2 Diabetic Patients Vs Non Diabetic patients

• Registration Number: CTRI/2012/06/002747
• Lead Sponsor: Max Super Speciality Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-06
• Last Update Posted: 2016-01-05

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

• CASE GROUP •Patients having diagnosis of type 2 diabetes as defined by American Diabetes Association (ADA 2011) criteria.
• •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).

Exclusion Criteria

• CASE GROUP •Associated drug and alcohol dependence.
• •Presence of organic illness associated with depression.
• •Any other major psychiatric illness, like Schizophrenia and mental retardation.
• •Patients with severe cognitive impairment.
• •Patient already on any psychotropic drug.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PRIMARY-Presence of depression in both the case and control (non-diabetic) groups at the time of assessment.	2 months

Secondary Outcome Measures

Name	Time	Method
SECONDARY-	1.Higher depression score in case of poor glycemic control.

Trial Locations

Locations (1)

Max Super Speciality Hospital; 🇮🇳 Delhi, DELHI, India

Max Super Speciality Hospital

🇮🇳Delhi, DELHI, India

Dr Sujeet Jha

Principal investigator

9910609000

sujeet.jha@maxhealthcare.com