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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00596817
First received: January 8, 2008
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Drug: Placebo
Drug: Vortioxetine (Lu AA21004)
Phase 3

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 [ Time Frame: Within first 24 weeks of the double-blind period ] [ 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:
  • 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 [ Time Frame: Within 64 weeks of the double-blind period ] [ Designated as safety issue: No ]
  • Change From Double-blind Baseline in MADRS Total Score After 24 Weeks of Double-blind Treatment [ Time Frame: Double-blind Baseline and Week 24 of the double-blind period ] [ Designated as safety issue: No ]
  • Change From Double-blind Baseline in HAM-D-17 Total Score After 24 Weeks of Double-blind Treatment [ Time Frame: Double-blind Baseline and Week 24 of the double-blind period ] [ Designated as safety issue: No ]
    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.

  • Change From Double-blind Baseline in HAM-A Total Score After 24 Weeks of Double-blind Treatment [ Time Frame: Double-blind Baseline and Week 24 of the double-blind period ] [ 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 Double-blind Baseline in CGI-S Score After 24 Weeks of Double-blind Treatment [ Time Frame: Double-blind Baseline and Week 24 of the double-blind period ] [ 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.

  • 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) [ Time Frame: Week 24 of the double-blind period (Counted From Open-label Baseline) ] [ Designated as safety issue: No ]
  • Proportion of Remitters at Week 24 of the Double-blind Period (Remission Defined as a MADRS Total Score <=10) [ Time Frame: Week 24 of the double-blind period ] [ Designated as safety issue: No ]
  • Change From Double-blind Baseline in SDS Total Score at Week 24 of the Double-blind Period [ Time Frame: Week 24 of the double-blind period (Counted From Double-blind Baseline) ] [ Designated as safety issue: No ]
    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.


Enrollment: 639
Study Start Date: December 2007
Study Completion Date: October 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
capsules, daily, orally
Experimental: Vortioxetine: 5 or 10 mg Drug: Vortioxetine (Lu AA21004)
encapsulated tablets, daily, orally
Other Name: Brintellix

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  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: NCT00596817

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: NCT00596817     History of Changes
Other Study ID Numbers: 11985A, 2007-001871-13
Study First Received: January 8, 2008
Results First Received: October 28, 2013
Last Updated: February 13, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Federal Office for Safety in Health Care
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Canada: Health Canada
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
India: Ministry of Health
Korea: Food and Drug Administration
Norway: Norwegian Medicines Agency
Poland: The Central Register of Clinical Trials
Sweden: Medical Products Agency
Taiwan: National Bureau of Controlled Drugs
Thailand: Food and Drug Administration
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
South Africa: Medicines Control Council

Keywords provided by H. Lundbeck A/S:
Relapse prevention
Antidepressants
Placebo-controlled
Double-blind
Multicentre study

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Vortioxetine
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin 5-HT1 Receptor Antagonists
Serotonin Antagonists
Serotonin 5-HT3 Receptor Antagonists

ClinicalTrials.gov processed this record on September 18, 2014