Overview
Open-label, Flexible-dose Study of Vortioxetine in Patients With Depression in India
Status:
Recruiting
Recruiting
Trial end date:
2022-03-18
2022-03-18
Target enrollment:
0
0
Participant gender:
All
All
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 IndiaPhase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
H. Lundbeck A/STreatments:
VortioxetineCriteria
Inclusion Criteria:- 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 Criteria:
- 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.