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

Lundbeck

Status and phase: Completed; Phase 4

Conditions: Major Depressive Disorder

Treatments: Drug: Vortioxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04288895

17775A

Details and patient eligibility

About

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

Enrollment: 400 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

400 participants in 1 patient group

Vortioxetine

Experimental group

Description:

flexible-dose

Treatment:

Drug: Vortioxetine