Efficacy Study of Vortioxetine (Lu AA21004) for Treatment of Major Depressive Disorder
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase III Study to Assess the Efficacy and Safety of Lu AA21004 in Patients With Major Depressive Disorder
3 other identifiers
interventional
366
1 country
32
Brief Summary
The purpose of this study is to assess the efficacy, safety and tolerability of 8-week treatment with Vortioxetine (Lu AA21004), once daily (QD), in Japanese participants with major depressive disorder. The purpose of this study is to assess the efficacy, safety and tolerability of 8-week treatment with Lu AA21004, once daily (QD), in Japanese participants with major depressive disorder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 major-depressive-disorder
Started May 2011
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 16, 2011
CompletedFirst Posted
Study publicly available on registry
May 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
November 11, 2014
CompletedNovember 11, 2014
November 1, 2014
1.6 years
May 16, 2011
November 4, 2014
November 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score After 8 Weeks of Treatment
MADRS is a 10-item clinician rated scale that measures overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. A negative change from Baseline indicates that symptoms have improved. An analysis of covariance (ANCOVA) model was used with change in MADRS total score as a dependent variable, treatment as a fixed effect and the baseline MADRS total score as a covariate.
Baseline, Week 8
Secondary Outcomes (5)
Percentage of Patients With MADRS Response After 8 Weeks of Treatment
Baseline, Week 8
Percentage of Patients With MADRS Remission After 8 Weeks of Treatment
Week 8
Change From Baseline in the Hamilton Depression Scale (HAM-D17) Total Score After 8 Weeks of Treatment
Baseline, Week 8
Clinical Global Impression Scale-Improvement (CGI-I) Score After 8 Weeks of Treatment
Baseline, Week 8
Change From Baseline in Sheehan Disability Scale (SDS) Total Score After 8 Weeks of Treatment
Baseline, Week 8
Study Arms (3)
Vortioxetine 5 mg
EXPERIMENTALVortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
Vortioxetine 10 mg
EXPERIMENTALVortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
Placebo
PLACEBO COMPARATORVortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
Interventions
Vortioxetine tablets
Eligibility Criteria
You may qualify if:
- The subject suffers from Major Depressive Disorder (MDD) as the primary diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria (classification code 296.2x and 296.3x).
- The reported duration of the current major depressive episode is at least 3 months at the Screening Visit.
- The subject has a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥26 at the Screening and Baseline Visits.
- The subject has a Clinical Global Impression Scale-Severity (CGI-S) score ≥4 at the Screening and Baseline Visits
You may not qualify if:
- The subject has one or more of the following conditions:
- Any current psychiatric disorder other than MDD as defined in the DSM-IV-TR. A subject who exhibits symptoms of anxiety is eligible unless the subject fulfills the diagnostic criteria for a current anxiety disorder per DSM-IV-TR.
- Current diagnosis or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
- Current diagnosis or history of any substance-related disorder (except nicotine and caffeine-related disorders) as defined in the DSM-IV-TR.
- Presence or history of a clinically significant neurological disorder (including epilepsy).
- Neurodegenerative disorder (Alzheimer's disease, Parkinson's disease, multiple sclerosis, Huntington's disease, etc.).
- Any DSM-IV-TR axis II disorder that might compromise the study.
- The current depressive symptoms of the subject are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.
- The subject is at significant risk of suicide or has a score ≥5 on Item 10 (suicidal thoughts) of the MADRS at the Screening and Baseline Visit, or has attempted suicide within 6 months prior to the Screening Visit.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (32)
Unknown Facility
Inzai-shi, Chiba, Japan
Unknown Facility
Noda, Chiba, Japan
Unknown Facility
Fukuoka, Fukuoka, Japan
Unknown Facility
Kitakyushu-shi, Fukuoka, Japan
Unknown Facility
Annaka-shi, Gunma, Japan
Unknown Facility
Fujioka-shi, Gunma, Japan
Unknown Facility
Takasaki-shi, Gunma, Japan
Unknown Facility
Hatsukaichi-shi, Hiroshima, Japan
Unknown Facility
Hiroshima, Hiroshima, Japan
Unknown Facility
Sapporo, Hokkaido, Japan
Unknown Facility
Amagasaki-shi, Hyōgo, Japan
Unknown Facility
Kobe, Hyōgo, Japan
Unknown Facility
Ibaraki, Ibaraki, Japan
Unknown Facility
Fujisawa-shi, Kanagawa, Japan
Unknown Facility
Kawasaki-shi, Kanagawa, Japan
Unknown Facility
Sagamihara-shi, Kanagawa, Japan
Unknown Facility
Yokohama, Kanagawa, Japan
Unknown Facility
Osaka, Kita-ku, Japan
Unknown Facility
Kumamoto, Kumamoto, Japan
Unknown Facility
Kyoto, Kyoto, Japan
Unknown Facility
Kurashiki-shi, Okayama-ken, Japan
Unknown Facility
Osaka, Osaka, Japan
Unknown Facility
Fukaya-shi, Saitama, Japan
Unknown Facility
Saitama, Saitama, Japan
Unknown Facility
Utsunomiya, Tochigi, Japan
Unknown Facility
Anan-shi, Tokushima, Japan
Unknown Facility
Tokushisma-shi, Tokushima, Japan
Unknown Facility
Hachioji-shi, Tokyo, Japan
Unknown Facility
Katsushika-ku, Tokyo, Japan
Unknown Facility
Musashino-shi, Tokyo, Japan
Unknown Facility
Tokyo, Tokyo, Japan
Unknown Facility
Nanyo-shi, Yamagata, Japan
Related Publications (1)
Inoue T, Nishimura A, Sasai K, Kitagawa T. Randomized, 8-week, double-blind, placebo-controlled trial of vortioxetine in Japanese adults with major depressive disorder, followed by a 52-week open-label extension trial. Psychiatry Clin Neurosci. 2018 Feb;72(2):103-115. doi: 10.1111/pcn.12623. Epub 2017 Dec 27.
PMID: 29160598DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director, Clinical Science
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Senior Manager
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2011
First Posted
May 17, 2011
Study Start
May 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
November 11, 2014
Results First Posted
November 11, 2014
Record last verified: 2014-11