Efficacy of Vortioxetine (Lu AA21004) in the Prevention of Relapse of Major Depressive Episodes

Major Depressive Disorder Clinical Trial

Official title:

A Double-blind, Randomised, Placebo-controlled, Multicentre, Relapse-prevention Study With Two Doses of [Vortioxetine] Lu AA21004 in Patients With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00596817
• Other study ID #: 11985A
• Secondary ID: 2007-001871-13
• Status: Completed
• Phase: Phase 3
• First received: January 8, 2008
• Last updated: February 13, 2014
• Start date: December 2007
• Est. completion date: October 2009

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 AdministrationAustria: Federal Office for Safety in Health CareBelgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentCanada: Health CanadaFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesIndia: Ministry of HealthKorea: Food and Drug AdministrationNorway: Norwegian Medicines AgencyPoland: The Central Register of Clinical TrialsSweden: Medical Products AgencyTaiwan: National Bureau of Controlled DrugsThailand: Food and Drug AdministrationTurkey: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencySouth Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy of Vortioxetine in the prevention of relapse of major depressive episodes in patients who responded to open-label treatment with Vortioxetine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 639
• Est. completion date: October 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Major Depressive Episode (MDE) as the primary diagnosis according to DSM-IV TR criteria

• At least one other MDE before the current one

• Moderate to severe depression

Exclusion Criteria:

• Any current psychiatric disorder other than Major Depressive Disorder (MDD) as defined in the DSM-IV TR

• Any substance disorder within the previous 6 months

• Female patients of childbearing potential who are not using effective contraception

• Use of any psychoactive medication 2 weeks prior to screening and during the study

Randomisation Criteria: Patients in remission (MADRS total score <=10) at both Week 10 and Week 12

Other protocol-defined inclusion and exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Placebo
capsules, daily, orally
• Vortioxetine (Lu AA21004)
encapsulated tablets, daily, orally

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

References & Publications (1)

Boulenger JP, Loft H, Florea I. A randomized clinical study of Lu AA21004 in the prevention of relapse in patients with major depressive disorder. J Psychopharmacol. 2012 Nov;26(11):1408-16. doi: 10.1177/0269881112441866. Epub 2012 Apr 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse Within First 24 Weeks of the Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator	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.	Within first 24 weeks of the double-blind period	No
Secondary	Relapse During the Entire Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator		Within 64 weeks of the double-blind period	No
Secondary	Change From Double-blind Baseline in MADRS Total Score After 24 Weeks of Double-blind Treatment		Double-blind Baseline and Week 24 of the double-blind period	No
Secondary	Change From Double-blind Baseline in HAM-D-17 Total Score After 24 Weeks of Double-blind Treatment	The Hamilton Depression Scale - 17 items (HAM-D-17) 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 52. The higher the score, the more severe.	Double-blind Baseline and Week 24 of the double-blind period	No
Secondary	Change From Double-blind Baseline in HAM-A Total Score After 24 Weeks of Double-blind 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.	Double-blind Baseline and Week 24 of the double-blind period	No
Secondary	Change From Double-blind Baseline in CGI-S Score After 24 Weeks of Double-blind 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.	Double-blind Baseline and Week 24 of the double-blind period	No
Secondary	Proportion of Responders at Week 24 of the Double-blind Period (Response Defined as a >=50% Reduction in MADRS Total Score From Open-label Baseline)		Week 24 of the double-blind period (Counted From Open-label Baseline)	No
Secondary	Proportion of Remitters at Week 24 of the Double-blind Period (Remission Defined as a MADRS Total Score <=10)		Week 24 of the double-blind period	No
Secondary	Change From Double-blind Baseline in SDS Total Score at Week 24 of the Double-blind Period	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.	Week 24 of the double-blind period (Counted From Double-blind Baseline)	No