Open-label Safety Extension Study of 2.5, 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, Flexible-dose, Extension 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: NCT00694304
• Other study ID #: 11984B
• Secondary ID: EudraCT 2007-004
• Status: Completed
• Phase: Phase 3
• First received: June 6, 2008
• Last updated: February 17, 2014
• Start date: May 2008
• Est. completion date: April 2010

Study information

• Verified date: February 2014
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationBulgaria: Bulgarian Drug AgencyCanada: Health CanadaCzech Republic: State Institute for Drug ControlEstonia: The State Agency of MedicineFinland: Finnish National Agency for MedicinesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Hong Kong: Department of HealthIndia: Drugs Controller General of IndiaKorea: Food and Drug AdministrationLatvia: State Agency of MedicinesLithuania: State Medicine Control Agency - Ministry of HealthMalaysia: Ministry of HealthPhilippines: Bureau of Food and DrugsRomania: National Agency for Medicines and Medical DevicesSlovenia: Agency for Medicinal Products - Ministry of HealthSpain: Spanish Agency of MedicinesTaiwan: National Bureau of Controlled DrugsTurkey: Ministry of HealthUkraine: Ministry of Health
• 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 8-week acute treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 535
• Est. completion date: April 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients who completed 8-week short-term treatment study for Major Depressive Episode, NCT00635219 / 11984A

Exclusion Criteria:

• Any current psychiatric disorder other than MDD as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Ed., 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)
2.5, 5, or 10 mg/day; tablets; orally

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

References & Publications (1)

Baldwin DS, Hansen T, Florea I. Vortioxetine (Lu AA21004) in the long-term open-label treatment of major depressive disorder. Curr Med Res Opin. 2012 Oct;28(10):1717-24. doi: 10.1185/03007995.2012.725035. Epub 2012 Sep 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Adverse Events (AEs)		Baseline to end of the 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	Change From Baseline in HAM-A Total Score After 52 Weeks of Treatment	The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe.	Baseline and Week 52	No
Secondary	Change From Baseline in CGI-S Score After 52 Weeks of Treatment	The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.	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
Secondary	Proportion of Patients With a MADRS Total Score >=22 After 52 Weeks of Treatment		Baseline and Week 52	No
Secondary	Change From Baseline in SDS Total Score After 52 Weeks of Treatment	The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe.	Baseline and Week 52	No