| 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
|
|
|
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
|
|
|
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. |