| CTRI Number |
CTRI/2012/06/002747 [Registered on: 26/06/2012] Trial Registered Retrospectively |
| Last Modified On: |
01/05/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study to Estimate the Prevalence of Depression in Type2 Diabetes Patients as compared to non-diabetic patients in a Tertiary Care Centre |
|
Scientific Title of Study
|
Prospective Comparative Study to Estimate the Prevalence of Depression in Type2 Diabetes Patients in a Tertiary Care Centre |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DDM001 VERSION-1.1 DATE- 2nd May 2012 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Samreen Siddiqui |
| Designation |
Clinical Research Trainee |
| Affiliation |
Max Super Speciality Hospital |
| Address |
Clnical Research Department
2 Press Enclave Road Saket
New Delhi
Endocrinology Department
2 Press Enclave Road Saket
New Delhi
New Delhi
DELHI
110017
India |
| Phone |
9582865898 |
| Fax |
|
| Email |
sid_samreen@hotmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Samreen Siddiqui |
| Designation |
Clinical Research Trainee |
| Affiliation |
Max Super Speciality Hospital |
| Address |
Clnical Research Department
2 Press Enclave Road Saket
New Delhi
Endocrinology Department
2 Press Enclave Road Saket
New Delhi
New Delhi
DELHI
110017
India |
| Phone |
9582865898 |
| Fax |
|
| Email |
sid_samreen@hotmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Samreen Siddiqui |
| Designation |
Clinical Research Trainee |
| Affiliation |
Max Super Speciality Hospital |
| Address |
Clnical Research Department
2 Press Enclave Road Saket
New Delhi
Endocrinology Department
2 Press Enclave Road Saket
New Delhi
New Delhi
DELHI
110017
India |
| Phone |
9582865898 |
| Fax |
|
| Email |
sid_samreen@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Max super spciality Hospital |
|
|
Primary Sponsor
|
| Name |
Max Super Speciality Hospital |
| Address |
2 Press enclave road
saket
new delhi |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sujeet Jha |
Max Super Speciality Hospital |
Endocrinology Department
5th Floor
2 Press Enclave Road
Saket
New Delhi
New Delhi
DELHI |
9910609000
sujeet.jha@maxhealthcare.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee Max Super Speciality Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Prevelance of depression in Type 2 Diabetic Patients Vs Non Diabetic patients, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
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) |
|
| ExclusionCriteria |
| Details |
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.
•Any past history of psychiatric disorder.
CONTROL GROUP
•Any past history of psychiatric disorder.
•Patients with severe cognitive impairment
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
PRIMARY-Presence of depression in both the case and control (non-diabetic) groups at the time of assessment.
|
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
SECONDARY-
1.Higher depression score in case of poor glycemic control.
2Depression is associated with diabetic neuropathy, nephropathy and diabetic foot and not associated with diabetic retinopathy
|
SECONDARY-
1.Higher depression score in case of poor glycemic control.
2Depression is associated with diabetic neuropathy, nephropathy and diabetic foot and not associated with diabetic retinopathy
|
|
Target Sample Size
Modification(s)
|
Total Sample Size="260"
Sample Size from India="260"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Siddiqui S, Jha S, Agarwal NB. Waghdhare S, Singh K. Prevalence of Depression in patients with Type 2 diabetes attending a Tertiary Clinic in India. Postgrad Med J Published Online First: [04 Aug 2014]
doi:10.1136/postgradmedj-2014-132593.
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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.
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.
|