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CTRI Number  CTRI/2023/09/057824 [Registered on: 18/09/2023] Trial Registered Prospectively
Last Modified On: 11/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Single Arm Study 
Public Title of Study   Evaluation of medication response in individuals having depressive disorder using blood test and brain activity and comparing them to healthy individuals 
Scientific Title of Study   A longitudinal observational study to evaluate antidepressant medication response using brain derived nerve growth factor and cortical hemodynamic and electrical activity  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ahmad Najjad Husain 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences New Delhi 
Address  Department of Psychiatry AIIMS New Delhi Ansari Nagar east

South West
DELHI
110029
India 
Phone  9447941574  
Fax    
Email  anajjadpatla@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rohit Verma 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences New Delhi 
Address  Department of Psychiatry, Room no. 4095 4th floor, Teaching block AIIMS, Ansari Nagar, New Delhi

South West
DELHI
110029
India 
Phone  9868005491  
Fax    
Email  rohit.aiims@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rohit Verma 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences New Delhi 
Address  Department of Psychiatry, Room no. 4095 4th floor, Teaching block AIIMS, Ansari Nagar, New Delhi

South West
DELHI
110029
India 
Phone  9868005491  
Fax    
Email  rohit.aiims@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Science, New Delhi, India 
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  Department of Psychiatry AIIMS New Delhi Ansari Nagar east 110029 
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 Ahmad Najjad Husain  All India Institute of Medical Science New Delhi  Room No. 4096, 4th Floor, Teaching Block Department of Psychiatry, AIIMS, Ansari Nagar New Delhi
South West
DELHI 
9447941574

anajjadpatla@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics committee for postgraduate research, AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Not suffering from any psychiatric illness on clinical evaluation 
Patients  (1) ICD-10 Condition: F332||Major depressive disorder, recurrent severe without psychotic features,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Inclusion criteria – MDD group
1. Age 18 to 55 years
2. Any gender
3. Right-handed subjects
4. Willing to give written informed consent
5. Ability to read Hindi or English language
6. Meeting DSM 5 criteria for Major Depressive Disorder (MDD)
7. Treatment naïve or Treatment free from prior 2 weeks or on a stable standard antidepressant regimen with no change in treatment in previous 4-weeks.
8. Prescribed antidepressants for treatment of MDD on the day of screening/recruitment
9. HAMD score ≥ 17 (moderate to severe depression) (Zimmerman et al., 2013)

Inclusion criteria – Healthy controls
1. Age (18 to 55 years) matched (± 5 years) and Gender matched
2. Right-handed
3. Willing to give written informed consent
4. Ability to read Hindi or English language
5. Not suffering from any psychiatric illness (on clinical evaluation) 
 
ExclusionCriteria 
Details 
1. Suffering from any psychotic symptoms or other psychiatric disorder or substance use disorder (except caffeine & nicotine) through clinical interview using DSM 5
2. Persistent Depressive Disorder (dysthymia), Premenstrual Dysphoric Disorder, Depressive Disorder Due to Another Medical Condition, Substance/ Medication Induced Depressive Disorder, Other and Unspecified Depressive Disorders based on DSM 5
3. History of seizures
4. Pregnancy/ Lactation
5. Uncontrolled medical illness
6. History suggestive of space occupying brain lesion or cerebrovascular accident
7. Current prescription or history within last 3-months of receiving any Psychotherapy/Neuromodulation
8. Actively suicidal as defined by a score of 4 on item 3 of HAMD
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in HAMD scores & cortical activity within patient group & comparison of cortical activity between patient group & healthy group  at baseline & after 4 & 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
BDNF gene polymorphism correlation with depression severity  baseline 
 
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)   25/09/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Worldwide, there is high prevalence of depressive disorder. Pharmacological treatment strategies to manage depression are limited by effectiveness as well as tolerability issues apart from the late onset of action. Extent of antidepressant medication response often differs with individual variation and surrogate markers predicting non-response at the earliest possible time are needed to avoid leaving patients under an inefficient medication/ treatment. The use of brain imaging techniques like fNIRS/qEEG can depict the cortical activity associated with the changes in symptoms of depression. Literature has reported lower levels of BDNF in depression that improves with response to treatment.  BDNF Val66Met polymorphism may help in predicting treatment responders.

The study hypothesizes that individuals with MDD differ from healthy individuals for prefrontal hemodynamic activity assessed using fNIRS and cortical electrical activity assessed using qEEG and that individuals with MDD after treatment with antidepressant medications demonstrate changes in depressive symptoms, Prefrontal hemodynamic activity assessed using fNIRS, cortical electrical activity assessed using qEEG and serum BDNF levels. The study also hypothesizes that the presence of Val66Met BDNF gene polymorphism is associated with change in depressive symptoms after antidepressant treatment in individuals with MDD.

Consultants and Senior Residents in the outpatient department (OPD) and inpatient department (IPD) of Psychiatry, AIIMS, New Delhi shall be requested to refer all the patients with depression. Out of the referred patients, those with HAMD score >17 (moderate depression) will be chosen by a purposive method for participation in the study. Diagnosis of severe depression will be confirmed using DSM-5 criteria by clinical interview and participants fulfilling the inclusion and exclusion criteria will be recruited. Participants will be screened for psychiatric comorbidities using clinical interview. Physical, neurological and substance use comorbidity as well as pregnancy/lactation will be ruled out by history and clinical examination. Written consent will be taken prior to participation in the study. Healthy controls will also be recruited similarly from the outpatient department (OPD) and inpatient department (IPD) of Psychiatry, AIIMS, New Delhi, who are meeting inclusion and exclusion criteria.

For both the groups baseline assessment will be done within 2 days of assessments by sociodemographic and clinical data using semi structured datasheet and outcome parameters by fNIRS and qEEG for both the group. For other outcome parameters will also be assessed namely HAMD, HAMA, BDNF and BDNF gene polymorphism.

Only the MDD group will be reassessed at 4 and 8 weeks (±2-3 days) using HAMD, HAMA, BDNF level, fNIRS, qEEG.

 
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