Open-label, Flexible-dose Study of Vortioxetine in Patients With Depression in India
1 other identifier
interventional
400
1 country
24
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of flexible doses of vortioxetine (5 - 20 mg/day) over a period of 12 weeks in patients with depression in India
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 major-depressive-disorder
Started Feb 2020
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 20, 2020
CompletedFirst Submitted
Initial submission to the registry
February 26, 2020
CompletedFirst Posted
Study publicly available on registry
February 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 11, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 12, 2022
CompletedMarch 18, 2022
March 1, 2022
2 years
February 26, 2020
March 17, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with Treatment-Emergent Adverse Events
From baseline to week 12
Secondary Outcomes (3)
Change in Patient Health Questionnaire-9 (PHQ-9) total score
From baseline to week 12
Change in Clinical Global Impression-severity of illness (CGI-S) score
From baseline to week 12
Clinical Global Impression-improvement (CGI-I)
At week 12
Study Arms (1)
Vortioxetine
EXPERIMENTALflexible-dose
Interventions
Eligibility Criteria
You may qualify if:
- The patient has a Major Depressive Episode (MDE), is diagnosed with Major Depressive Disorder (MDD) according to DSM-5® and would benefit from pharmacological treatment with vortioxetine. The current MDE should be confirmed using the Mini International Neuropsychiatric Interview (MINI).
- The patient has a CGI-S ≥4 at screening.
You may not qualify if:
- The patient has a significant risk of suicide according to investigator's clinical judgment or has made an actual suicide attempt in the period of 6 months prior to screening.
- The patient previously received vortioxetine.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lundbeck A/Slead
Study Sites (24)
Ratandeep Multispecialty Hospital (IN1002)
Ahmedabad, Gujarat, 380008, India
MITR Foundation 1 (IN1013)
Ahmedabad, Gujarat, 380013, India
BJ Medical College and Civil Hospital (IN028)
Ahmedabad, Gujarat, 380016, India
Shree Hatkesh Health Foundation (IN1016)
Jūnāgadh, Gujarat, 362001, India
Nagecha Hospital, Creative Chamber (IN1015)
Rajkot, Gujarat, 360001, India
Divyam Clinic (IN1025)
Surat, Gujarat, 395001, India
GMERS Medical College and Hospital,Department of Psychiatry (IN1004)
Vadodara, Gujarat, 390021, India
People Tree Hospitals (IN1027)
Bengaluru, Karnataka, 560 022, India
Vinaya Hospital & Research Centre (IN1007)
Mangalore, Karnataka, 575 003, India
Mangala Hospital & Mangala Kidney Foundation (IN1006)
Mangalore, Karnataka, 575003, India
K. S. Hegde Medical Academy (IN1003)
Mangalore, Karnataka, 575018, India
Department of Psychiatry K R Hospital Mysore Medical College and Research Institute (IN1020)
Mysuru, Karnataka, 570001, India
IQRAA International Hospital & Research Centre (IN030)
Kozhikode, Kerala, 673009, India
Society for Psychiatric Update and Research, Shanti Nursing Home (IN1008)
Aurangabad, Maharashtra, 431005, India
Arneja Heart and Multispeciality Hospital (IN1022)
Nagpur, Maharashtra, 440010, India
Central Institute of Behavioural Sciences (IN1019)
Nagpur, Maharashtra, 440010, India
Chopda Medicare & Research Centre (IN023)
Nashik, Maharashtra, 422005, India
Lata Mangeshkar Medical Foundation's (IN1001)
Pune, Maharashtra, 411004, India
Oyster and Pearl Hospital (IN1014)
Pune, Maharashtra, 411005, India
Dayanand Medical College and Hospital (IN024)
Ludhiana, Punjab, 141001, India
ASHA hospital (IN1018)
Hyderabad, Telangana, 500034, India
Deva Institute of Healthcare and Research PVT ltd. (IN1005)
Varanasi, Uttar Pradesh, 221005, India
Institute of Post Graduate Medical Education and Research (IN1026)
Kolkata, West Bengal, 700020, India
Maharaja Agarsen Hospital (IN1021)
Delhi, 110026, India
Related Publications (1)
Adair M, Bose R, Schmidt SN. Safety and effectiveness of vortioxetine in patients with major depressive disorder in a real-life clinical setting in India: results from an interventional, flexible-dose study. Curr Med Res Opin. 2024 Sep;40(9):1637-1645. doi: 10.1080/03007995.2024.2382773. Epub 2024 Aug 7.
PMID: 39110846DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Email contact via H. Lundbeck A/S
LundbeckClinicalTrials@Lundbeck.com
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2020
First Posted
February 28, 2020
Study Start
February 20, 2020
Primary Completion
February 11, 2022
Study Completion
March 12, 2022
Last Updated
March 18, 2022
Record last verified: 2022-03