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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Placebo
Vortioxetine (Lu AA21004)
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Relapse prevention, Antidepressants, Placebo-controlled, Double-blind, Multicentre study

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Placebo

    Vortioxetine: 5 or 10 mg

    Arm Description

    Outcomes

    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
    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
    Change From Double-blind Baseline in MADRS Total Score After 24 Weeks of Double-blind Treatment
    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.
    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.
    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.
    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)
    Proportion of Remitters at Week 24 of the Double-blind Period (Remission Defined as a MADRS Total Score <=10)
    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.

    Full Information

    First Posted
    January 8, 2008
    Last Updated
    February 13, 2014
    Sponsor
    H. Lundbeck A/S
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00596817
    Brief Title
    Efficacy of Vortioxetine (Lu AA21004) in the Prevention of Relapse of Major Depressive Episodes
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2007 (undefined)
    Primary Completion Date
    September 2009 (Actual)
    Study Completion Date
    October 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    H. Lundbeck A/S

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Major Depressive Disorder
    Keywords
    Relapse prevention, Antidepressants, Placebo-controlled, Double-blind, Multicentre study

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    639 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Title
    Vortioxetine: 5 or 10 mg
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    capsules, daily, orally
    Intervention Type
    Drug
    Intervention Name(s)
    Vortioxetine (Lu AA21004)
    Other Intervention Name(s)
    Brintellix
    Intervention Description
    encapsulated tablets, daily, orally
    Primary Outcome Measure Information:
    Title
    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
    Description
    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.
    Time Frame
    Within first 24 weeks of the double-blind period
    Secondary Outcome Measure Information:
    Title
    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
    Title
    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
    Title
    Change From Double-blind Baseline in HAM-D-17 Total Score After 24 Weeks of Double-blind Treatment
    Description
    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.
    Time Frame
    Double-blind Baseline and Week 24 of the double-blind period
    Title
    Change From Double-blind Baseline in HAM-A Total Score After 24 Weeks of Double-blind Treatment
    Description
    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.
    Time Frame
    Double-blind Baseline and Week 24 of the double-blind period
    Title
    Change From Double-blind Baseline in CGI-S Score After 24 Weeks of Double-blind Treatment
    Description
    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.
    Time Frame
    Double-blind Baseline and Week 24 of the double-blind period
    Title
    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)
    Title
    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
    Title
    Change From Double-blind Baseline in SDS Total Score at Week 24 of the Double-blind Period
    Description
    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.
    Time Frame
    Week 24 of the double-blind period (Counted From Double-blind Baseline)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Email contact via H. Lundbeck A/S
    Organizational Affiliation
    LundbeckClinicalTrials@lundbeck.com
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22495621
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    31818787
    Citation
    Christensen MC, Florea I, Loft H, McIntyre RS. Efficacy of vortioxetine in patients with major depressive disorder reporting childhood or recent trauma. J Affect Disord. 2020 Feb 15;263:258-266. doi: 10.1016/j.jad.2019.11.074. Epub 2019 Nov 13.
    Results Reference
    derived
    PubMed Identifier
    27780334
    Citation
    McIntyre RS, Florea I, Tonnoir B, Loft H, Lam RW, Christensen MC. Efficacy of Vortioxetine on Cognitive Functioning in Working Patients With Major Depressive Disorder. J Clin Psychiatry. 2017 Jan;78(1):115-121. doi: 10.4088/JCP.16m10744.
    Results Reference
    derived

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

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