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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00761306
• Other study ID #: 11492C
• Secondary ID: 2007-000905-31
• Status: Completed
• Phase: Phase 2
• First received: September 26, 2008
• Last updated: December 23, 2013
• Start date: June 2007
• Est. completion date: October 2008

Study information

• Verified date: December 2013
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research CouncilCanada: Health CanadaCzech Republic: State Institute for Drug ControlFinland: Finnish Medicines AgencyItaly: The Italian Medicines AgencyMalaysia: Ministry of HealthSlovakia: State Institute for Drug ControlSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: October 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Vortioxetine (Lu AA21004)
5 or 10 mg/day; tablets; orally

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Adverse Events (AEs)		Up to 52 weeks and a 4-week safety follow-up period	Yes
Primary	Percentage of Patients Who Withdrew Due to Intolerance to Treatment		Baseline to Week 52	Yes
Secondary	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.	Baseline and Week 52	No
Secondary	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.	Baseline and Week 52	No
Secondary	Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)		Week 52	No
Secondary	Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)		Week 52	No