Status:
COMPLETED
Open-label, Flexible-dose Study of Vortioxetine in Patients With Depression in India
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Other in- and exclusion criteria may apply.
Key Trial Info
Start Date :
February 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 12 2022
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04288895
Start Date
February 20 2020
End Date
March 12 2022
Last Update
March 18 2022
Active Locations (24)
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1
Ratandeep Multispecialty Hospital (IN1002)
Ahmedabad, Gujarat, India, 380008
2
MITR Foundation 1 (IN1013)
Ahmedabad, Gujarat, India, 380013
3
BJ Medical College and Civil Hospital (IN028)
Ahmedabad, Gujarat, India, 380016
4
Shree Hatkesh Health Foundation (IN1016)
Jūnāgadh, Gujarat, India, 362001