| CTRI Number |
CTRI/2024/06/069550 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
31/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Serum level of Interleukin 4, Interleukin 6 in patients
with major depressive disorder considering history of suicide attempts
|
|
Scientific Title of Study
|
Evaluation of serum level of Interleukin 4, Interleukin 6 in patients
with major depressive disorder considering history of suicide attempts
in a tertiary care hospital of Eastern India – A cross sectional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gunjan Gayen |
| Designation |
Post Graduate Trainee |
| Affiliation |
R G Kar Medical College and Hospital |
| Address |
Department of Pharmacology
2nd Floor Academic Building
R G kar Medical College and Hospital
1 Khudiram Bose Sarani
Kolkata
West Bengal
Kolkata
WEST BENGAL
700004
India |
| Phone |
6290918629 |
| Fax |
|
| Email |
gunjangayen75@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Payel Talukdar |
| Designation |
Associate Professor and Head Department of Psychiatry |
| Affiliation |
R G Kar Medical College and Hospital |
| Address |
Department of Psychiatry
4th Floor Academic Building
R G kar Medical College and Hospital
1 Khudiram Bose Sarani
Kolkata
West Bengal
Kolkata
WEST BENGAL
700004
India |
| Phone |
9433272944 |
| Fax |
|
| Email |
drpayeltalukdar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Payel Talukdar |
| Designation |
Associate Professor and Head Department of Psychiatry |
| Affiliation |
R G Kar Medical College and Hospital |
| Address |
Department of Psychiatry
4th Floor Academic Building
R G kar Medical College and Hospital
1 Khudiram Bose Sarani
Kolkata
West Bengal
WEST BENGAL
700004
India |
| Phone |
9433272944 |
| Fax |
|
| Email |
drpayeltalukdar@gmail.com |
|
|
Source of Monetary or Material Support
|
| R G Kar Medical College and Hospital
1 Khudiram Bose Sarani
Kolkata - 700004
West Bengal
India
|
|
|
Primary Sponsor
|
| Name |
R G Kar Medical College and Hospital |
| Address |
1 Khudiram Bose Sarani
Kolkata 700004
West Bengal |
| Type of Sponsor |
Government medical college |
|
|
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 Gunjan Gayen |
R G Kar Medical College and Hospital |
Out Patient Department
Room No 404
Department of Psychiatry
3rd Floor OPD Building
R G Kar Medical College and Hospital
1 khudiram Bose Sarani
Kolkata 700004
West Bengal
Kolkata
WEST BENGAL |
6290918629
gunjangayen75@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee R G Kar Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F329||Major depressive disorder, singleepisode, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient of age above 18 years suffering from major depressive disorder with a history of
suicide attempts.
2. Patients who will give informed consent for the study. |
|
| ExclusionCriteria |
| Details |
1. Patients who disagree to give consent.
2. Patients with a history of substance abuse except tobacco and alcohol.
3. Any chronic condition with cognitive dysfunction.
4. Clinical history of systemic autoimmune disease.
5. Patients receiving recent (last week) anti-inflammatory medication.
6. Patients with severe injuries will not be recruited in the first month following suicide attempts
(They will not be considered as a recent suicide attempt group). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out the link between serum IL 6, IL 4 and psychosocial variables in suicide attempts |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To enquire for the correlation between serum IL 6, IL 4 and major depressive disorder (MDD)
2. To assess the relationship between inflammatory markers (IL 6 and IL 4) and MDD considering
socio demographic factors of the patients |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="41"
Sample Size from India="41"
Final Enrollment numbers achieved (Total)= "41"
Final Enrollment numbers achieved (India)="41" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/07/2024 |
| Date of Study Completion (India) |
10/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patient suffering from Major Depressive Disorder (MDD) with a history of suicide attempts attending the in and outpatient department of Psychiatry of R G kar Medical College & Hospital, having given proper consent and fulfilling inclusion and exclusion criteria are taken into the study. Patients will be assessed using Mini International Neuropsychiatric Interview (M.I.N.I). Depressive symptoms will be evaluated using the Public Health Questionnaire (PHQ-9), Hamilton Depression Rating Scale (HDRS). Suicide attempts will be assessed by the Pierce Suicide Intent Scale. Serum IL 4 and IL 6 will be measured by ELISA technique. Descriptive statistics will be utilized for the expression of data. The P value of< 0.05 will be considered statistically significant at a 95 confidence interval. All the analysis will be done by using the SPSS version 27, Graphpad prism etc |