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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00839423
First received: February 6, 2009
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

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).


Condition Intervention Phase
Major Depressive Disorder
Drug: Placebo
Drug: Vortioxetine (Lu AA21004)
Drug: Venlafaxine XL
Phase 2

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

Resource links provided by NLM:


Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • Change From Baseline in MADRS Total Score After 6 Weeks of Treatment [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change From Baseline in MADRS Total Score After 1 Week of Treatment [ Time Frame: Baseline and Week 1 ] [ Designated as safety issue: No ]
  • Change From Baseline in HAM-D 24 Total Score After 6 Weeks of Treatment [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in HAM-A Total Score After 6 Weeks of Treatment [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in CGI-S Score After 6 Weeks of Treatment [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    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.

  • Change in Clinical Status Using CGI-I Score at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    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.

  • Proportion of Responders at Week 6 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Proportion of Remitters at Week 6 (Remission is Defined as a MADRS Total Score <=10) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Enrollment: 426
Study Start Date: August 2006
Study Completion Date: September 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
capsules, daily, orally
Experimental: Vortioxetine (Lu AA21004) 5 mg Drug: Vortioxetine (Lu AA21004)
encapsulated tablets, daily, orally
Other Name: Brintellix
Experimental: Vortioxetine (Lu AA21004) 10 mg Drug: Vortioxetine (Lu AA21004)
encapsulated tablets, daily, orally
Other Name: Brintellix
Venlafaxine XL 225 mg
Active Reference
Drug: Venlafaxine XL
capsules, daily, orally
Other Name: Effexor®

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00839423

Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  More Information

Publications:
Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT00839423     History of Changes
Other Study ID Numbers: 11492A, 2006-001515-29
Study First Received: February 6, 2009
Results First Received: October 28, 2013
Last Updated: April 22, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Agency for Health and Food Safety
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: The Italian Medicines Agency
Malaysia: Ministry of Health
Slovakia: State Institute for Drug Control
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency

Keywords provided by H. Lundbeck A/S:
Major depressive disorder
Placebo-controlled
Active reference
Multicenter study
Randomised study
Acute treatment

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Venlafaxine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014