Open-label Safety Extension Study of 15 and 20 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults

Lundbeck

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: Vortioxetine (Lu AA21004)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01323478

2010-024198-38 (EudraCT Number)

13267B

Details and patient eligibility

About

To evaluate the long-term safety and tolerability of flexible doses, 15 and 20 mg/day, of Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD)

Enrollment: 71 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients who completed 8-week short-term treatment study, 13267A (NCT01140906), for Major Depressive Episode immediately prior to enrolment in this extension study

Exclusion criteria

• Any current psychiatric disorder other than MDD as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV TR)
• Female patients of childbearing potential who are not using effective contraception
• Use of any psychoactive medication
• The patient, in the investigator's clinical judgment, has a significant risk of suicide.

Other protocol-defined inclusion and exclusion criteria applied.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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71 participants in 1 patient group

Vortioxetine

Experimental group

Treatment:

Drug: Vortioxetine (Lu AA21004)