| CTRI Number |
CTRI/2022/07/043662 [Registered on: 04/07/2022] Trial Registered Prospectively |
| Last Modified On: |
02/07/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical efficacy of Vortioxetine vs Escitalopram in depressive disorder |
|
Scientific Title of Study
|
A 12-week Randomized Controlled Study to compare the antidepressant efficacy of Vortioxetine and Escitalopram in patients with depressive episode |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vikhram Ramasubramanian |
| Designation |
Consultant Psychiatrist |
| Affiliation |
Ahana hospitals, LLP |
| Address |
Ahana hospitals, Department of psychiatry Research Division. 2nd floor, No.11.Subburam Street, Gandhi Nagar, Madurai.
Madurai
TAMIL NADU
625020
India |
| Phone |
9443772233 |
| Fax |
|
| Email |
vikhram@ahanahospitals.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Vikhram Ramasubramanian |
| Designation |
Consultant Psychiatrist |
| Affiliation |
Ahana hospitals, LLP |
| Address |
Ahana hospitals, Department of psychiatry Research Division. 2nd floor, No.11.Subburam Street, Gandhi Nagar, Madurai.
Madurai
TAMIL NADU
625020
India |
| Phone |
9443772233 |
| Fax |
|
| Email |
vikhram@ahanahospitals.in |
|
Details of Contact Person
Public Query
|
| Name |
Vikhram Ramasubramanian |
| Designation |
Consultant Psychiatrist |
| Affiliation |
Ahana hospitals, LLP |
| Address |
Ahana hospitals, Department of psychiatry Research Division. 2nd floor, No.11.Subburam Street, Gandhi Nagar, Madurai.
Madurai
TAMIL NADU
625020
India |
| Phone |
9443772233 |
| Fax |
|
| Email |
vikhram@ahanahospitals.in |
|
|
Source of Monetary or Material Support
|
| Ahana Hospitals LLP, No.11.Subburam Street, Gandhi Nagar, Madurai-625020, Tamilnadu, India |
|
|
Primary Sponsor
|
| Name |
Ahana Hospitals LLP |
| Address |
Ahana Hospitals LLP
11,subburam street, Madurai |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| vikhram ramasubramanian |
Ahana hospitals LLP |
Department of Psychiatry, Research division, No 11, subburaman street, Madurai
Madurai
TAMIL NADU |
9443772233
vikhram@ahanahospitals.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Radianz Healthcare and Research |
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 |
Escitalopram |
Escitalopram will be started at a dose of 10 mg once daily
and increased to 20 mg/day after 2 weeks. |
| Intervention |
Vortioxetine |
Vortioxetine will be started at a dose of 10 mg once daily
and increased to 20 mg/day after 2 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are meeting International Classification of Diseases 10 criteria for major depressive disorder
Patients who gave informed written consent. |
|
| ExclusionCriteria |
| Details |
Patients with other comorbid psychiatric disorder (except major depressive disorder)
Patients who were having comorbid substance
dependence
Patients with any other medical disorder which is
confounding our inclusion diagnosis |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 17-item Hamilton Depression Scale (HAM-D17) done at baseline, 2nd week, 4th week and 12th weeks |
17-item Hamilton Depression Scale (HAM-D17) done at baseline, 2nd week, 4th week and 12th weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| CGI- severity of illness (CGI-S) and improvement scale (CGI-I) done at baseline, 2nd week, 4th week and 12th week |
CGI- severity of illness (CGI-S) and improvement scale (CGI-I) done at baseline, 2nd week, 4th week and 12th week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
04/07/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Vortioxetine is a novel antidepressant, promoted for its multi-modal actions and comparatively lesser side effects. Not many studies have compared the clinical efficacy of vortioxetine to commonly prescribed oral antidepressants. Hence in our study we intend to compare the efficacy of vortioxetine to escitalopram for a period of 12 weeks. |