Randomised Placebo-controlled Venlafaxine-referenced Study of Efficacy and Safety of 5 and 10 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Adults

Major Depressive Disorder Clinical Trial

Official title:

Double-blind, Randomised, Placebo-controlled Study Comparing the Efficacy and Safety of Two Fixed Dosages of a Novel Antidepressant Compound to That of Placebo in Patients With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00839423
• Other study ID #: 11492A
• Secondary ID: 2006-001515-29
• Status: Completed
• Phase: Phase 2
• First received: February 6, 2009
• Last updated: April 22, 2014
• Start date: August 2006
• Est. completion date: September 2007

Study information

• Verified date: April 2014
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationAustria: Agency for Health and Food SafetyCanada: Health CanadaCzech Republic: State Institute for Drug ControlFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Italy: The Italian Medicines AgencyMalaysia: Ministry of HealthSlovakia: State Institute for Drug ControlSpain: Spanish Agency of MedicinesSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this Venlafaxine-referenced study is to evaluate the efficacy, safety and tolerability of two fixed doses of Vortioxetine in the acute treatment of Major Depressive Disorder (MDD).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 426
• Est. completion date: September 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• MDE as primary diagnosis according to DSM-IV-TR criteria (classification code 296.xx)

• Current MDE duration of at least 3 months and less than 12 months

• The patient has a MADRS total score >=30

Exclusion Criteria:

• Any current psychiatric disorder other than 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

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
• Venlafaxine XL
capsules, daily, orally

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

References & Publications (1)

Alvarez E, Perez V, Dragheim M, Loft H, Artigas F. A double-blind, randomized, placebo-controlled, active reference study of Lu AA21004 in patients with major depressive disorder. Int J Neuropsychopharmacol. 2012 Jun;15(5):589-600. doi: 10.1017/S146114571 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in MADRS Total Score After 6 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 6	No
Secondary	Change From Baseline in MADRS Total Score After 1 Week of Treatment		Baseline and Week 1	No
Secondary	Change From Baseline in HAM-D 24 Total Score After 6 Weeks of Treatment	The 24-item Hamilton Depression Rating Scale (HAM-D) is based on the 21-item HAM-D plus an additional 3 items (helplessness, hopelessness, and worthlessness). The observer makes his/her assessment on the basis of a specific statement, content, tone, facial expression, and gestures of the patient during the interview, and scores each item from 0 to 2 or 0 to 4. Total score from 0 to 76. The higher the score, the more severe.	Baseline and Week 6	No
Secondary	Change From Baseline in HAM-A Total Score After 6 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 6	No
Secondary	Change From Baseline in CGI-S Score After 6 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 6	No
Secondary	Change in Clinical Status Using CGI-I Score at Week 6	The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment.	Week 6	No
Secondary	Proportion of Responders at Week 6 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)		Week 6	No
Secondary	Proportion of Remitters at Week 6 (Remission is Defined as a MADRS Total Score <=10)		Week 6	No