| CTRI Number |
CTRI/2022/04/041636 [Registered on: 04/04/2022] Trial Registered Prospectively |
| Last Modified On: |
24/03/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Suicide crisis syndrome and depression |
|
Scientific Title of Study
|
Correlates of the suicide crisis syndrome in major depression: A multicentric exploratory study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Niteen Nagnath Abhivant |
| Designation |
Associate Professor |
| Affiliation |
BJ Govt Medical college and SGH,Pune |
| Address |
Block no 26, Department of Psychiatry, B.J. Govt. Medical college and Sasoon General Hospital,Pune
Sassoon General Hospital,Agarkar Nagar Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
|
| Fax |
|
| Email |
abhivantniteen@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Niteen Nagnath Abhivant |
| Designation |
Associate Professor |
| Affiliation |
BJ Govt Medical college and SGH,Pune |
| Address |
BJ Govt Medical college and Sasoon General Hospital,Pune
Sassoon General Hospital,Agarkar Nagar Pune
MAHARASHTRA
411011
India |
| Phone |
|
| Fax |
|
| Email |
abhivantniteen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Niteen Nagnath Abhivant |
| Designation |
Associate Professor |
| Affiliation |
BJ Govt Medical college and SGH,Pune |
| Address |
Block no 26, Department of Psychiatry, B.J. Govt Medical college and Sasoon General Hospital,Pune
Sassoon General Hospital,Agarkar Nagar Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
|
| Fax |
|
| Email |
abhivantniteen@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Psychiatry, B.J.Govt. Medical college and Sassoon general hospital, Pune |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Niteen Abhivant |
BJGMC & SGH, PUNE |
Block no. 26, Department of Psychiatry, Sassoon general hospital, Near Railway station, Agarkar Nagar, Pune -411001
Pune
MAHARASHTRA |
9323931441
abhivantniteen@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BJ Govt Medical College, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F32||Major depressive disorder, singleepisode, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
For cases
All consenting adult individuals between the age of 18-65 years diagnosed with major depressive disorder will be included.
For comparison group
All consenting consecutive age (±5years) and gender matched apparently healthy individuals aged between 18-65 years. They will be selected from healthy, non-biological relatives/friends accompanying patients in psychiatry OPD or healthy volunteers/ non-biological attendants in psychiatry ward. |
|
| ExclusionCriteria |
| Details |
1. Patients with evidence of intellectual disability
2. Patients with psychotic symptoms
3. Patients who are medically unstable enough for interview
4. Pregnant women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the socio-demographic and clinical correlates of the suicide crisis syndrome in patients with MDD. |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
02/05/2022 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This will be a cross sectional study with a comparison group conducted at outpatient as well as inpatient departments of multiple centres across India. The present study aims to study the correlates of the Suicide Crisis Syndrome(SCS) in an Indian sample with major depressive disorder(MDD). The primary objective of the study is to assess the socio-demographic and clinical correlates of the suicide crisis syndrome in patients with MDD. WE hypothesize that the SCS will have statistically significant correlation with socio-demographic and clinical correlates of the patient suffering from MDD. |