| CTRI Number |
CTRI/2024/09/073258 [Registered on: 03/09/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To check safety, effectiveness and utility of vortioxetine as initial line therapy in the Management of depression |
|
Scientific Title of Study
|
To assess the safety, effectiveness and utility of vortioxetine as initial line therapy in the Management of depression through an observational, multicenter Study |
| Trial Acronym |
IMPRESS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TPL2306463 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vishal Damani |
| Designation |
Principal Investigator |
| Affiliation |
OM psychiatric clinic |
| Address |
Ground floor, Shashwat Arcade, Opposite BOB, Bhulabhai Char rasta, Kankaria Rd
Ahmadabad
GUJARAT
380022
India |
| Phone |
7096586855 |
| Fax |
|
| Email |
vishaldamani123@proton.me |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishal Damani |
| Designation |
Principal Investigator |
| Affiliation |
OM psychiatric clinic |
| Address |
Ground floor, Shashwat Arcade, Opposite BOB, Bhulabhai Char rasta, Kankaria Rd
GUJARAT
380022
India |
| Phone |
7096586855 |
| Fax |
|
| Email |
vishaldamani123@proton.me |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishnaprasad K |
| Designation |
General Manager - Medical Strategic Affairs (India,RoW) |
| Affiliation |
Torrent Pharmaceuticals Ltd. |
| Address |
Torrent Pharmaceuticals Ltd., Torrent House, Ashram Road - Navrangpura, Ahmedabad
Ahmadabad
GUJARAT
380009
India
Ahmadabad
GUJARAT
380009
India |
| Phone |
7069000572 |
| Fax |
|
| Email |
krishnaprasadkorukonda@torrentpharma.com |
|
|
Source of Monetary or Material Support
|
| Torrent Pharmaceuticals Ltd., Ashram Road - Navrangpura, Ahmedabad, GUJARAT-380009, India |
|
|
Primary Sponsor
|
| Name |
Torrent Pharmaceuticals Ltd. |
| Address |
Torrent Pharmaceuticals Ltd., Torrent House, Ashram Road, Navrangpura, Ahmedabad 380009 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Vishal Damani |
OM psychiatric clinic |
Ground floor, Shashwat Arcade, Opposite BOB, Bhulabhai Char rasta, Kankaria Rd
Ahmadabad
GUJARAT
380022
India
Ahmadabad
GUJARAT |
7096586855
vishaldamani123@proton.me |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sangini Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F329||Major depressive disorder, singleepisode, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Adult Male or female patients
Treatment Naïve or known cases of MDD and treated with Vortioxetine as initial line therapy
|
|
| ExclusionCriteria |
| Details |
Are allergic to vortioxetine or any of the ingredients in medicine |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Safety assessment
Usage pattern for Vortioxetine
o Dose of Vortioxetine
o Duration of Vortioxetine therapy
o Co-prescription(s) along with Vortioxetine
|
At 4 week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in depression severity based on PHQ-9 scores
Demographic pattern
Physician Global Assessment on Effectiveness of Vortioxetine
Patient treatment acceptability
Prevalence of other co-morbid conditions along with Depression
Prescribed medications used for co-morbid conditions along with depression
|
At 4 week |
|
|
Target Sample Size
|
Total Sample Size="3500"
Sample Size from India="3500"
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)
|
02/07/2025 |
| 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="0"
Months="0"
Days="30" |
|
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
|
To
evaluate the safety effectiveness and utility of vortioxetine as initial line
therapy in Indian patients with major depressive disorder (MDD) . study design: Post Approval Observation Study Duration of Observation: 4 weeks Study Drug: vortioxetine
|