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CTRI Number  CTRI/2024/10/075579 [Registered on: 21/10/2024] Trial Registered Prospectively
Last Modified On: 19/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Six months follow up study on functioning disability, real world outcome and recovery of participants in depression 
Scientific Title of Study   A six months follow up of unipolar depression-recovery and dysfunction in a naturalistic prospective 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 Titir Surai 
Designation  Junior Resident,Department of Psychiatry 
Affiliation  Kasturba Medical College,Manipal 
Address  Department of Psychiatry, OPD block,3rd floor, Room no:33, Kasturba Hospital, Manipal 576104
Manipal Academy of Higher Education,Madhav Nagar,Manipal
Udupi
KARNATAKA
576104
India 
Phone  7278826158  
Fax    
Email  tsurai14@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr PSVN Sharma 
Designation  Professor,Department of Psychiatry 
Affiliation  Kasturba Medical College,Manipal 
Address  Department of Psychiatry, OPD block,3rd floor, Room no:33, Kasturba Hospital, Manipal 576104

Udupi
KARNATAKA
576104
India 
Phone  08202922778  
Fax    
Email  psvn.sharma@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Abhiram PN 
Designation  Assistant Professor,Department of Psychiatry 
Affiliation  Kasturba Medical College,Manipal 
Address  Department of Psychiatry, OPD block,3rd floor, Room no:33, Kasturba Hospital, Manipal 576104

Udupi
KARNATAKA
576104
India 
Phone  08202922217  
Fax    
Email  abhiram.pn@manipal.edu  
 
Source of Monetary or Material Support  
Department of Psychiatry, OPD block,3rd floor, Room no:33, Kasturba Hospital, Manipal 576104 
 
Primary Sponsor  
Name  Department of Psychiatry 
Address  Department of Psychiatry, OPD block,3rd floor, Room no:33, Kasturba Hospital, Manipal 576104 
Type of Sponsor  Private 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 Titir Surai  Kasturba Hospital  Department of Psychiatry, OPD block,3rd floor, Room no:33, Kasturba Hospital, Manipal 576104
Udupi
KARNATAKA 
7278826158

tsurai14@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 (Student Research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F32||Major depressive disorder, singleepisode, (2) ICD-10 Condition: F33||Major depressive disorder, recurrent,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Any patient with current diagnosis of depressive episode(single episode/recurrent)as per ICD-11.
Those who are on adequate doses of antidepressants therapy.
Those coming for follow up at the Department of Psychiatry,Kasturba Hospital 
 
ExclusionCriteria 
Details  Those not able to read English/Hindi/Kannada.
Those not willing to consent. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The correlation between baseline symptom severity, melancholic symptoms, suicidality and functioning in patients with major depressive episode at 1st,3rd and 6th-month follow-up
 
O,4-6 weeks, 12-14 weeks, 24-28 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
The severity of depressive symptoms in patients with major depressive episode at 1st,3rd and 6th-month follow-up in a naturalistic treatment setting.
 
O,4-6 weeks, 12-14 weeks, 24-28 weeks 
 
Target Sample Size   Total Sample Size="65"
Sample Size from India="65" 
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)   01/11/2024 
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="2"
Months="0"
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  

The study will evaluate the short-term outcome of major depressive episode in a naturalistic treatment setting. 

OBJECTIVES- 1)To assess the severity of depressive symptoms in patients with major depressive episode at 1st,3rd and 6th-month follow-up in a naturalistic treatment setting. 2)To assess melancholic symptoms in patients with Major depressive episode at 1st,3rd and 6th-month follow-up in a naturalistic treatment setting. 3) To assess the correlation between baseline symptom severity, melancholic symptoms, suicidality and functioning in patients with major depressive episode at 1st,3rd and 6th-month follow-up in a naturalistic treatment setting.

The study will be carried out over a period of around 24 months on 65 patients from psychiatry OPD or inpatient ward..Patients with current Diagnosis of Depressive episode (single episode/recurrent) as per ICD-11 and The inventory of depressive symptomatology : Clinician (IDS-C) score of >13, aged 18-60 years, either gender, able to give written informed consent; able to understand English, Hindi or Kannada, on adequate dose of antidepressant treatment will be included except patients non-compliance to medications, not cooperative for comprehensive assessments, receive ECT or ketamine infusion therapy. Primary data will be collected by obtaining first-hand information from the respondents themselves regarding the socio-demographic details based on a semi-structured proforma followed by administration of a series of rating scales over a period of one and half to two hours to evaluate melancholic symptoms, suicidal risk and functioning at baseline.Same patients will be interviewed again in follow up at first(4-6 weeks), third(12-14 weeks) and sixth(24-26 weeks)month during their out-patient visit over a period of 40-50 minutes. During this interview depressive symptoms and functioning will be assessed. Finally the data will be streamlined and statistical analysis will be carried out to assess analyse and correlate the symptoms of the illness and findings of the study using scientific methods. 

 
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