A Long-term, Open-label Study Evaluating the Safety and Tolerability of [Vortioxetine] Lu AA21004 in Patients With Major Depressive Disorder

H. Lundbeck A/S0 sites74 target enrollmentJune 2007

ConditionsMajor Depressive Disorder

InterventionsVortioxetine (Lu AA21004)

DrugsVortioxetine (Lu AA21004)

Overview

Phase: Phase 2
Intervention: Vortioxetine (Lu AA21004)
Conditions: Major Depressive Disorder
Sponsor: H. Lundbeck A/S
Enrollment: 74
Primary Endpoint: Number of Patients With Adverse Events (AEs)
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2007

End Date

October 2008

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

H. Lundbeck A/S

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

Vortioxetine

Intervention: Vortioxetine (Lu AA21004)

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(Baseline and Week 52)
Change From Baseline in HAM-D-24 Total Score After 52 Weeks of Treatment(Baseline and Week 52)
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)