Efficacy and Safety Study of Vortioxetine (Lu AA21004) for Treatment of Major Depressive Disorder
A Multinational, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Assess the Efficacy and Safety of Lu AA21004 in Patients With Major Depressive Disorder
5 other identifiers
interventional
600
16 countries
70
Brief Summary
The purpose of this study is to assess the efficacy and safety of multiple doses of vortioxetine, once daily (QD), in participants with major depressive disorder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2010
Shorter than P25 for phase_2
70 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 6, 2010
CompletedFirst Posted
Study publicly available on registry
December 7, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedResults Posted
Study results publicly available
December 18, 2013
CompletedDecember 18, 2013
October 1, 2013
1.3 years
December 6, 2010
October 25, 2013
October 25, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least squares (LS) means were from an Analysis of Covariance (ANCOVA) model with treatment as a fixed factor and the Baseline value as a covariate.
Baseline and Week 8
Secondary Outcomes (4)
Percentage of Participants With a MADRS Response at Week 8
Baseline and Week 8
Percentage of Participants in MADRS Remission at Week 8
Week 8
Mean Clinical Global Impression Scale - Improvement (CGI-I) Score at Week 8
Week 8
Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8
Baseline and Week 8
Study Arms (4)
Placebo
EXPERIMENTALVortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
Vortioxetine 5 mg
EXPERIMENTALVortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
Vortioxetine 10 mg
EXPERIMENTALVortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
Vortioxetine 20 mg
EXPERIMENTALVortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
Interventions
Vortioxetine tablets
Vortioxetine placebo-matching tablets
Eligibility Criteria
You may qualify if:
- Suffers from Major Depressive Disorder as the primary diagnosis according to 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.
- Has a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥26 at the Screening and Baseline Visits.
- Has a Clinical Global Impression Scale-Severity (CGI-S) score ≥4 at the Screening and Baseline Visits.
You may not qualify if:
- Has one or more of the following conditions:
- Any current psychiatric disorder other than Major Depressive Disorder as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR; assessed by the Mini International Neuropsychiatric Interview: MINI). A participant who exhibits symptoms of anxiety is eligible unless fulfilling 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. Participant with confirmed positive urine drug screens (except prescribed medications or a medication that does not constitute drug abuse) will be excluded.
- 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 participant are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.
- Has received electroconvulsive, vagal nerve stimulation, or repetitive transcranial magnetic stimulation therapy within 6 months prior to the Screening Visit.
- Is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
- Is at significant risk of suicide or has a score ≥5 on Item 10 (suicidal thoughts) of the MADRS, or has attempted suicide within 6 months prior to the Screening Visit.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (70)
Unknown Facility
Split, Croatia, Croatia
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Zagreb, Croatia, Croatia
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Helsinki, Finland, Finland
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Kuopio, Finland, Finland
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Oulu, Finland, Finland
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Tampere, Finland, Finland
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Berlin, Germany, Germany
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Bochum, Germany, Germany
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Chemnitz, Germany, Germany
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Hanover, Germany, Germany
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Leipzig, Germany, Germany
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München, Germany, Germany
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Nuremberg, Germany, Germany
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Schwerin, Germany, Germany
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Westerstede, Germany, Germany
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Wiesbaden, Germany, Germany
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Hong Kong, Hong Kong, Hong Kong
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Hyderabad, Andhra Pradesh, India
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Ahmedabad, Gujarat, India
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Kanpur, Uttar Pradesh, India
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Lucknow, Uttar Pradesh, India
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Varanasi, Uttar Pradesh, India
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Tokoname-shi, Aichi-ken, Japan
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Fukuoka, Fukuoka, Japan
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Kitakyushu-shi, Fukuoka, Japan
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Omuta-shi, Fukuoka, Japan
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Shirakawa-shi, Fukushima, Japan
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Sapporo, Hokkaido, Japan
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Yokohama, Kanagawa, Japan
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Kumamoto, Kumamoto, Japan
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Tokyo, Tokyo, Japan
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Liepāja, Latvia, Latvia
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Riga, Latvia, Latvia
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Sigulda, Latvia, Latvia
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Johor Bahru, Malaysia, Malaysia
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Kuala Lumpur, Malaysia, Malaysia
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Makati City, NCR, Philippines
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Mandaluyong, NCR, Philippines
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Manila, NCR, Philippines
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Quezon City, NCR, Philippines
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Bialystok, Poland, Poland
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Gorlice, Poland, Poland
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Leszno, Poland, Poland
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Torun, Poland, Poland
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Żuromin, Poland, Poland
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Iași, Lasi, Romania
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Târgu Mureş, Mureș County, Romania
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Bucharest, Romania, Romania
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Nizhny Novgorod, Russia, Russia
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Rostov-on-Don, Russia, Russia
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Saint Petersburg, Russia, Russia
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Smolensk, Russia, Russia
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Stavropol, Russia, Russia
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Yekaterinburg, Russia, Russia
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Belgrade, Serbia, Serbia
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Kragujevac, Serbia, Serbia
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Senta, Serbia, Serbia
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Sungnam-si, Gyeonggi-do, South Korea
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Incheon, Korea, South Korea
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Seoul, Korea, South Korea
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Yangsan, Korea, South Korea
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Changhua, Taiwan, Taiwan
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Kaohsiung City, Taiwan, Taiwan
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Taipei, Taiwan, Taiwan
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Taoyuan Hsien, Taiwan, Taiwan
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Chernigiv Region, Ukraine, Ukraine
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Dnipropetrovsk, Ukraine, Ukraine
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Kharkiv, Ukraine, Ukraine
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Kiev, Ukraine, Ukraine
Unknown Facility
Luhansk, Ukraine, Ukraine
Related Publications (2)
Adair M, Christensen MC, Florea I, Loft H, Fagiolini A. Vortioxetine in patients with major depressive disorder and high levels of anxiety symptoms: An updated analysis of efficacy and tolerability. J Affect Disord. 2023 May 1;328:345-354. doi: 10.1016/j.jad.2023.01.074. Epub 2023 Jan 26.
PMID: 36708956DERIVEDNishimura A, Aritomi Y, Sasai K, Kitagawa T, Mahableshwarkar AR. Randomized, double-blind, placebo-controlled 8-week trial of the efficacy, safety, and tolerability of 5, 10, and 20 mg/day vortioxetine in adults with major depressive disorder. Psychiatry Clin Neurosci. 2018 Feb;72(2):64-72. doi: 10.1111/pcn.12565. Epub 2017 Oct 3.
PMID: 28858412DERIVED
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
Medical Director Clinical Science
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- 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
December 6, 2010
First Posted
December 7, 2010
Study Start
November 1, 2010
Primary Completion
March 1, 2012
Study Completion
April 1, 2012
Last Updated
December 18, 2013
Results First Posted
December 18, 2013
Record last verified: 2013-10