| CTRI Number |
CTRI/2025/07/090799 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
12/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Vortioxetine and Escitalopram, in Adults with Depression |
|
Scientific Title of Study
|
Vortioxetine versus Escitalopram in Major Depressive Disorder A Comparative Study of Efficacy, Safety, Functional Improvement and Quality of Life |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR GARIMA GUPTA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
SANTOSH MEDICAL COLLEGE, SDTU |
| Address |
Department of Pharmacology, Santosh Medical College 1, Santosh Nagar, Pratap Vihar
Department of Pharmacology, Santosh Medical College 1, Santosh Nagar, Pratap Vihar
Ghaziabad
UTTAR PRADESH
201009
India |
| Phone |
8700331910 |
| Fax |
|
| Email |
garima.gupta15.gg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MOHD SAJID KHAN |
| Designation |
PROFESSOR |
| Affiliation |
SANTOSH MEDICAL COLLEGE, SDTU |
| Address |
Department of Pharmacology, Santosh Medical College 1, Santosh Nagar, Pratap Vihar
Department of Pharmacology, Santosh Medical College 1, Santosh Nagar, Pratap Vihar
Ghaziabad
UTTAR PRADESH
201009
India |
| Phone |
9810849797 |
| Fax |
|
| Email |
drsajidrana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR GARIMA GUPTA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
SANTOSH MEDICAL COLLEGE, SDTU |
| Address |
DEPARTMENT OF PHARMACOLOGY, SANTOSH MEDICAL COLLEGE 1, SANTOSH NAGAR, PRATAP VIHAR, GHAZIABAD, UTTAR PRADESH- 201009 (DELHI NCR) INDIA
SANTOSH MEDICAL COLLEGE 1, SANTOSH NAGAR, PRATAP VIHAR, GHAZIABAD, UTTAR PRADESH- 201009 (DELHI NCR)
Ghaziabad
UTTAR PRADESH
201009
India |
| Phone |
8700331910 |
| Fax |
|
| Email |
garima.gupta15.gg@gmail.com |
|
|
Source of Monetary or Material Support
|
| SANTOSH MEDICAL COLLEGE AND HOSPITAL GHAZIABAD, UTTAR PRADESH |
|
|
Primary Sponsor
|
| Name |
DR GARIMA GUPTA |
| Address |
DEPARTMENT OF PHARMACOLOGY, SANTOSH MEDICAL COLLEGE 1, SANTOSH NAGAR, PRATAP VIHAR, GHAZIABAD, UTTAR PRADESH- 201009 (DELHI NCR) INDIA
SANTOSH MEDICAL COLLEGE 1, SANTOSH NAGAR, PRATAP VIHAR, GHAZIABAD, UTTAR PRADESH- 201009 (DELHI NCR) |
| Type of Sponsor |
Other [] |
|
|
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 GARIMA GUPTA |
Santosh Medical College and Hospital |
Room no. 1, third floor, Department of Pharmacology, Santosh Medical College, Santosh nagar, Pratap vihar , 201009
Ghaziabad
UTTAR PRADESH |
8700331910
garima.gupta15.gg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ESCITALOPRAM |
20mg/day per oral for a total duration of 24 weeks |
| Intervention |
VORTIOXETINE |
20mg/day, per oral , for a total duration of 24 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1) Adults aged 18-55 years diagnosed with moderate major depressive disorder based on DSM-5 criteria.
2) Patients with a Hamilton Depression Rating Scale score between 14-22 indicating moderate depression.
3) Those who have not used antidepressants in the past three months.
4) Those patients or caregivers who are willing to give written infomred consent form. |
|
| ExclusionCriteria |
| Details |
1) Who have not previously experienced hypersensitivity or contraindication to vortioxetine or escitalopram
2)Clinical situation requiring alternative drugs or intervention.
3)Drugs which are CYP3A4/2D6 and CYP2C19 inhibitors and inducers ( Concomitant medication)
4)Any co-morbid neurological or mental disorder.
5)Any serious medical/surgical illness.
6)Established treatment resistance to antidepressants
7)History of drug or alcohol abuse in the last six months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of vortioxetine and escitalopram in improving depressive symptoms in patients with moderate to major depressive disorder, using standardized rating scales over a 24-week treatment period. |
baseline, 8, 16 and 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the safety & tolerability of vortioxetine & escitalopram by assessing adverse events & dropout rates during the treatment course.
To assess functional improvement in patients receiving either vortioxetine or escitalopram using tools like the Sheehan Disability Scale (SDS).
To compare quality of life outcomes using validated questionnaires between the two treatment groups.
|
0,8,16,24 weeks |
|
|
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)
|
28/07/2025 |
| 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="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
|
The study " Vortioxetine versus Escitalopram in Major Depressive Disorder: A Comparative Study of Efficacy, Safety, Functional Improvement and Quality of Life" will be conducted at the Department of Pharmacology in association with the Department of Psychiatry, Santosh Medical College and Hospital, Ghaziabad, Uttar Pradesh, 201009. The subjects of the study will be the patients of Major Depressive Disorder attending the Psychiatry Outpatient Department, Santosh hospital, Ghaziabad, Uttar Pradesh based on the inclusion and exclusion criteria. All patients selected for the study will be well informed about the study and a written informed consent will be taken. After recruitments patients will be allocated into two groups by randomization technique. Group A will be treated with Vortioxetine 20mg/day for 24 weeks. Group B will be treated with Escitalopram 20mg/day for 24 weeks. |