Back to resultsStudy of Vortioxetine (Lu AA21004) in Major Depressive Disorder in Asian Countries
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Vortioxetine (Lu AA21004)
Venlafaxine extended release
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring MDD
Eligibility Criteria
Inclusion Criteria:
- The patient suffers from recurrent MDD as the primary diagnosis according to DSM-IVTR™ criteria. The current Major Depressive Episode (MDE) should be confirmed using the Mini International Neuropsychiatric Interview (MINI)
- The patient has a MADRS total score ≥26
- The patient has a CGI-S score ≥4
- The reported duration of the current MDE is ≥3 months.
Other inclusion criteria may apply.
Exclusion Criteria:
- The patient meets any of the exclusion criteria listed in the protocol or, in the investigator's opinion, is unlikely to comply with the protocol or is unsuitable for any reason.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Vortioxetine (Lu AA21004)
Venlafaxine extended release
Arm Description
Outcomes
Primary Outcome Measures
Change From Baseline in MADRS Total Score at Week 8
Montgomery and Asberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. The total score of the ten items ranges from 0 to 60. The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
Secondary Outcome Measures
Change in CGI-S Score From Baseline to Week 8
Clinical Global Impression Scale - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). Higher score indicates that the subject is more ill, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
CGI-I Score at Week 8
The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not. Higher score = more affected.
Change in HAM-A Total Score From Baseline to Week 8
Hamilton Anxiety Rating Scale (HAM-A) is a 14-item rating scale designed to assess the global anxiety. Each symptom is rated from 0 (absent) to 4 (maximum severity). The total score of the 14 items ranges from 0 to 56. Higher score indicates greater anxiety, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
MADRS Response at Week 8 (Response Defined as a ≥50% Decrease in the MADRS Total Score From Baseline)
Remission at Week 8 (Remission Defined as a MADRS Total Score ≤10)
Number of Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01571453
Brief Title
Study of Vortioxetine (Lu AA21004) in Major Depressive Disorder in Asian Countries
Official Title
Randomised, Double-blind, Parallel-group, Active-comparator (Venlafaxine Extended Release), Fixed-dose Study of [Vortioxetine] Lu AA21004 in Major Depressive Disorder in Asian Countries
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
undefined (undefined)
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 be conducted with the aim of investigating the efficacy, safety and tolerability of 10 mg/day Vortioxetine in Asian patients compared to an approved active comparator (venlafaxine extended release 150 mg/day).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
MDD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
437 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vortioxetine (Lu AA21004)
Arm Type
Experimental
Arm Title
Venlafaxine extended release
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Vortioxetine (Lu AA21004)
Other Intervention Name(s)
Brintellix
Intervention Description
10 mg/day
Intervention Type
Drug
Intervention Name(s)
Venlafaxine extended release
Other Intervention Name(s)
Efexor® XL
Intervention Description
150 mg/day
Primary Outcome Measure Information:
Title
Change From Baseline in MADRS Total Score at Week 8
Description
Montgomery and Asberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. The total score of the ten items ranges from 0 to 60. The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
Time Frame
Baseline and Week 8
Secondary Outcome Measure Information:
Title
Change in CGI-S Score From Baseline to Week 8
Description
Clinical Global Impression Scale - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). Higher score indicates that the subject is more ill, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
Time Frame
Baseline and Week 8
Title
CGI-I Score at Week 8
Description
The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not. Higher score = more affected.
Time Frame
Week 8
Title
Change in HAM-A Total Score From Baseline to Week 8
Description
Hamilton Anxiety Rating Scale (HAM-A) is a 14-item rating scale designed to assess the global anxiety. Each symptom is rated from 0 (absent) to 4 (maximum severity). The total score of the 14 items ranges from 0 to 56. Higher score indicates greater anxiety, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
Time Frame
Baseline and Week 8
Title
MADRS Response at Week 8 (Response Defined as a ≥50% Decrease in the MADRS Total Score From Baseline)
Time Frame
Week 8
Title
Remission at Week 8 (Remission Defined as a MADRS Total Score ≤10)
Time Frame
Week 8
Title
Number of Adverse Events
Time Frame
Baseline to Week 12
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:
The patient suffers from recurrent MDD as the primary diagnosis according to DSM-IVTR™ criteria. The current Major Depressive Episode (MDE) should be confirmed using the Mini International Neuropsychiatric Interview (MINI)
The patient has a MADRS total score ≥26
The patient has a CGI-S score ≥4
The reported duration of the current MDE is ≥3 months.
Other inclusion criteria may apply.
Exclusion Criteria:
- The patient meets any of the exclusion criteria listed in the protocol or, in the investigator's opinion, is unlikely to comply with the protocol or is unsuitable for any reason.
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
31990207
Citation
Wang G, Zhao K, Reynaud-Mougin C, Loft H, Ren H, Eriksen HF, Ettrup A. Successfully treated patients with vortioxetine versus venlafaxine: a simplified cost-effectiveness analysis based on a head-to-head study in Asian patients with major depressive disorder. Curr Med Res Opin. 2020 May;36(5):875-882. doi: 10.1080/03007995.2020.1723072. Epub 2020 Feb 13.
Results Reference
derived
PubMed Identifier
25650503
Citation
Wang G, Gislum M, Filippov G, Montgomery S. Comparison of vortioxetine versus venlafaxine XR in adults in Asia with major depressive disorder: a randomized, double-blind study. Curr Med Res Opin. 2015 Apr;31(4):785-94. doi: 10.1185/03007995.2015.1014028. Epub 2015 Feb 19.
Results Reference
derived
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Study of Vortioxetine (Lu AA21004) in Major Depressive Disorder in Asian Countries
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