| CTRI Number |
CTRI/2025/07/090857 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Creating a treatment plan for depressive patients using patient focused Holistic (Mind, Body and Social support) approach |
|
Scientific Title of Study
|
Formulating CARE plan in treatment of Major Depressive Disorder using Bio-Psycho-Social model : A case series 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 |
Dr. Utkarsh Mittal |
| Designation |
MD Part 1 Resident |
| Affiliation |
Dr.M.L.Dhawale memorial homoeopathic institute |
| Address |
301-Department of Psychiatry, Dr ML Dhawale Memorial Homoeopathic institute, ST Workshop, Boisar - Palghar Rd, Palghar Taluka Industrial Co Operative Estate, Palghar, Maharashtra 401404
301-Department of Psychiatry, Dr ML Dhawale Memorial Homoeopathic institute, ST Workshop, Boisar - Palghar Rd, Palghar Taluka Industrial Co Operative Estate, Palghar, Maharashtra 401404
Thane
MAHARASHTRA
401404
India |
| Phone |
9773060860 |
| Fax |
|
| Email |
utkarsh.mittal1963@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. RAJESH YADAV |
| Designation |
READER |
| Affiliation |
Dr.M.L.Dhawale memorial homoeopathic institute |
| Address |
301-Department of Psychiatry, Dr ML Dhawale Memorial Homoeopathic institute, ST Workshop, Boisar - Palghar Rd, Palghar Taluka Industrial Co Operative Estate, Palghar, Maharashtra 401404
Thane
MAHARASHTRA
401404
India |
| Phone |
9975023272 |
| Fax |
|
| Email |
docrajesh87h@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR. RAJESH YADAV |
| Designation |
READER |
| Affiliation |
Dr.M.L.Dhawale memorial homoeopathic institute |
| Address |
301-Department of Psychiatry, Dr ML Dhawale Memorial Homoeopathic institute, ST Workshop, Boisar - Palghar Rd, Palghar Taluka Industrial Co Operative Estate, Palghar, Maharashtra 401404
301-Department of Psychiatry, Dr ML Dhawale Memorial Homoeopathic institute, ST Workshop, Boisar - Palghar Rd, Palghar Taluka Industrial Co Operative Estate, Palghar, Maharashtra 401404
Thane
MAHARASHTRA
401404
India |
| Phone |
9975023272 |
| Fax |
|
| Email |
docrajesh87h@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr.M.L Dhawale memorial homoepathic institute |
| Address |
301,Dr M L Dhawale Memorial Homoeopathic Institute, Palghar
Palghar – Boisar Road, Opp. S.T. Workshop, Palghar-401 404, Dist. Palghar, Maharashtra, India |
| Type of Sponsor |
Private 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 Rajesh Yadav |
Dr M.L DHAWALE HOMEOPATHIC MEMORIAL INSTITUTES |
301-Department of Psychiatry, Dr ML Dhawale Memorial Homoeopathic institute, ST Workshop, Boisar - Palghar Rd, Palghar Taluka Industrial Co Operative Estate, Palghar, Maharashtra 401404
Thane
MAHARASHTRA |
9975023272
docrajesh87h@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, MLDMHI, Palghar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G50-G59||Nerve, nerve root and plexus disorders, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients from age group 18 years and above
Patients of all sexes
Patients diagnosed with Major Depressive Disorder using ICD11 |
|
| ExclusionCriteria |
| Details |
Major depressive disorder cases with psychosis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To formulate care plan by identifying the various Biological, Psychological and Social factors using Diagnostic Net Tool in cases of major depressive disorder. |
1.5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| no secondary outcome |
no secondary outcome |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
25/07/2025 |
| 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="5"
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
|
Background:
Major Depressive Disorder (MDD) is a multifactorial condition influenced by biological vulnerabilities, psychological processes, and social stressors. While pharmacotherapy remains the cornerstone of treatment, evidence supports better outcomes with integrated approaches. The Biopsychosocial (BPS) model provides a comprehensive framework for understanding and managing MDD, yet there is limited clinical documentation on individualized care plans developed using this model in real-world settings.
Purpose:
This case series aims to develop and implement individualized care plans for patients with MDD using the Biopsychosocial model. The objective is to assess feasibility, clinical response, and engagement when biological (pharmacological), psychological (therapy-based), and social (support-system based) interventions are integrated. This study will help generate insights into holistic management strategies and provide a structured template for multidisciplinary care in MDD.
|