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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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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