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

Phase 2

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Vortioxetine (Lu AA21004)

• Registration Number: NCT00761306
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Primary Completion: 2008-09
• Study First Submitted: 2008-09-26
• Study First Submitted QC: 2008-09-26
• Study First Posted: 2008-09-29
• Study Completion: 2008-10
• Results First Submitted: 2013-10-28
• Results First Submitted QC: 2013-10-28
• Status Verified: 2013-12
• Results First Posted: 2013-12-17
• Last Update Submitted: 2013-12-23
• Last Update Posted: 2014-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vortioxetine	Vortioxetine (Lu AA21004)	-

Primary Outcome Measures

Name	Time	Method
Number of Patients With Adverse Events (AEs)	Up to 52 weeks and a 4-week safety follow-up period
Percentage of Patients Who Withdrew Due to Intolerance to Treatment	Baseline to Week 52

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in MADRS Total Score After 52 Weeks of Treatment	Baseline and Week 52	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.
Change From Baseline in HAM-D-24 Total Score After 52 Weeks of Treatment	Baseline and Week 52	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.
Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)	Week 52
Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)	Week 52