| CTRI Number |
CTRI/2024/07/071516 [Registered on: 29/07/2024] Trial Registered Prospectively |
| Last Modified On: |
27/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of CD4 T cell count and its subsets in patients with major depressive disorder |
|
Scientific Title of Study
|
Evaluation of CD4 T cell count and its subsets Th1 ,Th2 and Th17 cells in patients with major depressive disorder |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Madhumitha Surulirajan |
| Designation |
Post graduate |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Biochemistry Maulana Azad Medical College New Delhi Department of Biochemistry Maulana Azad Medical College New Delhi Central DELHI 110002 India |
| Phone |
6379797569 |
| Fax |
|
| Email |
Madhu.surulirajan96@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Lal Chandra |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no 207 Pathology block Maulana Azad Medical College
Central DELHI 110002 India |
| Phone |
9873167313 |
| Fax |
|
| Email |
lchandra70@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Madhumitha Surulirajan |
| Designation |
Post graduate |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Biochemistry Maulana Azad Medical College New Delhi
Central DELHI 110002 India |
| Phone |
6379797569 |
| Fax |
|
| Email |
Madhu.surulirajan96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Biochemistry, Maulana Azad medical college,New Delhi -110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College New Delhi 110002 |
| 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 Madhumitha surulirajan |
GB pant hospital |
Department of psychiatry,OPD ground floor Central DELHI |
6379797569
madhu.surulirajan96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstitutionalEthicsCommittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age more than eighteen years
Patient having major depressive episode without psychotic symptoms for at least two weeks according to ICD eleven criteria
First onset MDD
Patients attended and evaluated by senior residents or consultants
Indication of anti depressant therapy
Patients agreeing to be part of the study
Brief Adherence Rating Scale more than eighty percent on follow up after eight weeks of treatment
Controls
Age and gender matched healthy volunteers who come to OPD of GIPMER LNH GNEC New Delhi
General Health Questionnaire twelve items (GHQ less than three |
|
| ExclusionCriteria |
| Details |
Any other psychiatric diagnosis except MDD
Substance use except nicotine containing agents Disorders due to substance use include disorders that result from a single occasion or repeated use of substances that have psychoactive properties including certain medications
Acute and chronic major physical illness
Independent variables
MDD and its severity
Anti depressant therapy
Demography and socioeconomic status
Patient with MDD will be treated as per SOP of Department of Psychiatry GIPMER
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
CD 4 T Cell count
Th1 th2 th17 cell count
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Treatment response treatment resistant depression |
6 months |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Depression is one of the most burdensome psychiatric conditions having atleast five of the symptoms occurring most of the day, nearly every day for past two weeks as mentioned in ICD-11 criteria.1 As per ICD 11, depressive episodes are classified based severity and associated psychotic symptoms as (a) mild depressive episode, (b) moderate depressive episode without psychotic symptoms, (c) moderate depressive episode with psychotic symptoms, (d) Severe depressive episode without psychotic symptoms and (e) severe depressive episode with psychotic symptoms.1 It has been studied that 1 in 40 persons have history of depression in the past, 1 in 20 persons suffer from current depression and 0.9 % of population have high self-injury and suicide risk.2 There are many etiologic factors that causes depression e.g., stressful life events, early maladaptive schema, genetic, hormonal, Immune dysfunction, etc.3 Alteration in innate and adaptive immune status affects the prognosis and action of antidepressant.3 IL-6 and TNF alpha are elevated in acute depressive episode and are decreased after treatment.4 Th17 cells are increased in patients showing non- responsiveness to antidepressant therapy.4 Peripheral T-cells are responsible for neuroplasticity and plays a role in both the development and resolution of depression.5 Neurogenic stress induced in the body alters the permeability of the blood brain barrier resulting in entry of peripheral cytokines to brain causing mood disorder.5 Depression itself disturbs the Hypothalamo-Pituitary-Adrenal axis and autonomic nervous system which induces production of more cytokines worsening the symptoms.6 The drug of choice for the patients with major depressive disorder (MDD) were Tricyclic anti-depressants previously.7 But, now Selective serotonin reuptake inhibitors (SSRI) and atypical antidepressants has become the choice.7-8 Despite the advancement in treatment options, one third of patient develops treatment resistance.9 However, there is hardly any method to know among the patients who is going to develop Treatment Resistant Depression (TRD). This will be an attempt to find out if CD4+ T-cell count and its subsets alter in MDD and can differentiate Treatment Resistant Depression (TRD) and non-Treatment Resistant Depression at the time of presentation. This study will also assess if immune status of MDD patient with tendency for self-injury and suicide differs from those MDD patients without having those tendency.
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