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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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Placebo
Vortioxetine (Lu AA21004)
Venlafaxine XL
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 Major depressive disorder, Placebo-controlled, Active reference, Multicenter study, Randomised study, Acute treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Other

    Arm Label

    Placebo

    Vortioxetine (Lu AA21004) 5 mg

    Vortioxetine (Lu AA21004) 10 mg

    Venlafaxine XL 225 mg

    Arm Description

    Active Reference

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Change From Baseline in MADRS Total Score After 1 Week of Treatment
    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.
    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.
    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.
    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.
    Proportion of Responders at Week 6 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)
    Proportion of Remitters at Week 6 (Remission is Defined as a MADRS Total Score <=10)

    Full Information

    First Posted
    February 6, 2009
    Last Updated
    April 22, 2014
    Sponsor
    H. Lundbeck A/S
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00839423
    Brief Title
    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
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2006 (undefined)
    Primary Completion Date
    August 2007 (Actual)
    Study Completion Date
    September 2007 (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
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Major Depressive Disorder
    Keywords
    Major depressive disorder, Placebo-controlled, Active reference, Multicenter study, Randomised study, Acute treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    426 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Title
    Vortioxetine (Lu AA21004) 5 mg
    Arm Type
    Experimental
    Arm Title
    Vortioxetine (Lu AA21004) 10 mg
    Arm Type
    Experimental
    Arm Title
    Venlafaxine XL 225 mg
    Arm Type
    Other
    Arm Description
    Active Reference
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Venlafaxine XL
    Other Intervention Name(s)
    Effexor®
    Intervention Description
    capsules, daily, orally
    Primary Outcome Measure Information:
    Title
    Change From Baseline in MADRS Total Score After 6 Weeks of Treatment
    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
    Baseline and Week 6
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in MADRS Total Score After 1 Week of Treatment
    Time Frame
    Baseline and Week 1
    Title
    Change From Baseline in HAM-D 24 Total Score After 6 Weeks of Treatment
    Description
    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.
    Time Frame
    Baseline and Week 6
    Title
    Change From Baseline in HAM-A Total Score After 6 Weeks of 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
    Baseline and Week 6
    Title
    Change From Baseline in CGI-S Score After 6 Weeks of 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
    Baseline and Week 6
    Title
    Change in Clinical Status Using CGI-I Score at Week 6
    Description
    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.
    Time Frame
    Week 6
    Title
    Proportion of Responders at Week 6 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)
    Time Frame
    Week 6
    Title
    Proportion of Remitters at Week 6 (Remission is Defined as a MADRS Total Score <=10)
    Time Frame
    Week 6

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    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
    21767441
    Citation
    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/S1461145711001027. Epub 2011 Jul 18.
    Results Reference
    result

    Learn more about this trial

    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

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