Open-label Flexible-dose Study of Vortioxetine in Patients With Depression in India

  • STATUS
    Recruiting
  • participants needed
    400
  • sponsor
    H. Lundbeck A/S
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Updated on 16 February 2024
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depressive disorder
depressive episode
depression
vortioxetine
major depressive disorder, single episode

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

Details
Condition Major depression, Endogenous depression
Age 18years - 65years
Treatment Vortioxetine
Clinical Study IdentifierNCT04288895
SponsorH. Lundbeck A/S
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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