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

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

Recruiting
18-65 years
All
Phase 4

Overview

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

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.

Study details
    Major depression
    Endogenous depression

NCT04288895

H. Lundbeck A/S

16 February 2024

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