| CTRI Number |
CTRI/2026/01/101457 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
17/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to understand how substance use affects the severity of depression. |
|
Scientific Title of Study
|
Pattern of comorbid substance use in
depressive disorders |
| 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 Sagar Sondhi |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
Government Medical College and Hospital, Sector 32, Chandigarh |
| Address |
Department of Psychiatry, Level 5, D block, Government Medical
College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160032
India
Chandigarh
CHANDIGARH
160032
India |
| Phone |
9417103660 |
| Fax |
|
| Email |
Sondhi.sagar11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajeet Sidana |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Sector 32, Chandigarh |
| Address |
Department of Psychiatry, Level 5, D block, Government Medical
College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160032
India
Chandigarh
CHANDIGARH
160032
India |
| Phone |
9056422679 |
| Fax |
0172-2609360 |
| Email |
ajeetsidana@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajeet Sidana |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Sector 32, Chandigarh |
| Address |
Department of Psychiatry, Level 5, D block, Government Medical
College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160032
India
CHANDIGARH
160032
India |
| Phone |
9056422679 |
| Fax |
0172-2609360 |
| Email |
ajeetsidana@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital, Sector 32, Chandigarh.
India.
160032. |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital Sector Chandigarh |
| Address |
Sector 32, Chandigarh
India.
160032 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sagar Sondhi |
Mental Health Institute, sector 32, Chandigarh |
ground floor
Chandigarh
CHANDIGARH |
9417103660
Sondhi.sagar11@gmail.com |
| Dr Sagar Sondhi |
Govenment Medical College and Hospital, Sector 32, Chandigarh. OPD |
Room no 4212, Level 4,
D block,
Chandigarh
CHANDIGARH |
9417103660
Sondhi.sagar11@gmail.com |
| Dr Sagar Sondhi |
Government Medical College and Hospital, South Campus, Sector 48, Chandigarh.IPD |
Level 3
Chandigarh
CHANDIGARH |
9417103660
Sondhi.sagar11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, GMCH Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F320||Major depressive disorder, singleepisode, mild, (2) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate, (3) ICD-10 Condition: F322||Major depressive disorder, singleepisode, severe without psychotic features, (4) ICD-10 Condition: F324||Major depressive disorder, singleepisode, in partial remission, (5) ICD-10 Condition: F325||Major depressive disorder, singleepisode, in full remission, (6) ICD-10 Condition: F328||Other depressive episodes, (7) ICD-10 Condition: F329||Major depressive disorder, singleepisode, unspecified, (8) ICD-10 Condition: F330||Major depressive disorder, recurrent, mild, (9) ICD-10 Condition: F331||Major depressive disorder, recurrent, moderate, (10) ICD-10 Condition: F332||Major depressive disorder, recurrent severe without psychotic features, (11) ICD-10 Condition: F334||Major depressive disorder, recurrent, in remission, (12) ICD-10 Condition: F338||Other recurrent depressive disorders, (13) ICD-10 Condition: F339||Major depressive disorder, recurrent, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient fulfilling the criteria for depressive disorders as per ICD 11 |
|
| ExclusionCriteria |
| Details |
1.Patients with acute medical or surgical illness
2.Uncooperative and violent patient
3. Patients with active psychotic symptoms hampering the interview
4.Actively suicidal patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the pattern of comorbid substance use in depressive disorders. |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess the types of substance use & its association with the severity of depressive
disorders.
2.To assess the quality of life in subjects using different substances. |
baseline |
|
|
Target Sample Size
|
Total Sample Size="262"
Sample Size from India="262"
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)
|
28/01/2026 |
| 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
|
This study is a cross-sectional observational study designed to assess the occurrence and patterns of substance use among patients diagnosed with depressive disorder as per ICD-11. Depression is commonly associated with substance use, which can worsen symptom severity, delay remission and reduce quality of life. The study will be conducted in the walk-in clinic, inpatient department and community outreach services of the Department of Psychiatry at Government Medical College and Hospital, Chandigarh. A total of 262 adult patients, aged 18 to 60 years, who fulfil the inclusion and exclusion criteria, will be enrolled after obtaining written informed consent. Participants will be assessed using standard clinical rating scales to evaluate depressive symptoms, anxiety, substance use, and quality of life. There is no additional financial burden or risk to the participants. All information collected will be kept confidential. Participation in the study is voluntary, and participants may withdraw at any time without affecting their ongoing treatment. |