Open-label Safety Extension Study of 5 and 10 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults

H. Lundbeck A/S74 enrolled

Overview

The purpose of the study is to evaluate long-term safety and tolerability of Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD) having completed 6-week acute treatment in study NCT00839423 / 11492A.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Major Depressive Disorder

Interventions

Vortioxetine (Lu AA21004)DRUG

5 or 10 mg/day; tablets; orally

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: \- Patients who completed 6-week short-term treatment study for Major Depressive Episode (MDE), NCT00839423 / 11492A, followed by a 2-week taper period 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 Other protocol-defined inclusion and exclusion criteria may apply.

Outcomes

Primary Outcomes

Number of Patients With Adverse Events (AEs)

Time frame: Up to 52 weeks and a 4-week safety follow-up period

Percentage of Patients Who Withdrew Due to Intolerance to Treatment

Time frame: Baseline to Week 52

Secondary Outcomes

Change From Baseline in MADRS Total Score After 52 Weeks of Treatment

The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.

Time frame: Baseline and Week 52

Change From Baseline in HAM-D-24 Total Score After 52 Weeks of Treatment

The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.

Time frame: Baseline and Week 52

Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)

Time frame: Week 52

Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)

Time frame: Week 52

Data from ClinicalTrials.gov

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