Efficacy and Safety of Vortioxetine (Lu AA21004) in Treating Adults With Major Depressive Disorder
A Randomized, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study Comparing the Efficacy and Safety of Lu AA21004 Versus Placebo in Acute Treatment of Adults With Major Depressive Disorder
2 other identifiers
interventional
600
3 countries
33
Brief Summary
The purpose of this study is to determine the efficacy and safety of once daily vortioxetine (Lu AA21004) in adults 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_3 major-depressive-disorder
Started Apr 2008
Shorter than P25 for phase_3 major-depressive-disorder
33 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
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 2, 2008
CompletedFirst Posted
Study publicly available on registry
May 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedResults Posted
Study results publicly available
December 13, 2013
CompletedDecember 13, 2013
October 1, 2013
7 months
May 2, 2008
April 19, 2013
October 24, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Week 6
The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range is from 0 to 74 where a higher score indicates a greater depressive state. Least squares (LS) means were from an Analysis of Covariance (ANCOVA) model with treatment and center as fixed factors and the baseline value as a covariate.
Baseline and Week 6
Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed
The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.
Baseline and Weeks 1, 2, 3, 4 and 5
Secondary Outcomes (11)
Percentage of Responders in HAM-D24 Total Score by Study Visit
Baseline and Weeks 1, 2, 3, 4, 5 and 6.
Percentage of Participants in MADRS Remission at Week 6
Week 6
Percentage of Participants With a Sustained Response in HAM-D24
Baseline to Week 6
Change From Baseline in Montgomery Ã…sberg Depression Rating Scale (MADRS) Total Score
Baseline and Weeks 1, 2, 3, 4, 5 and 6.
Change From Baseline in Hamilton Anxiety Scale (HAM-A)
Baseline and Weeks 1, 2, 4 and 6.
- +6 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORVortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
Vortioxetine
EXPERIMENTALVortioxetine 5 mg, encapsulated tablet, orally, once daily for up to 6 weeks.
Interventions
Encapsulated immediate-release tablets.
Eligibility Criteria
You may qualify if:
- Suffers from a major depressive episode (MDE) as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria.
- The reported duration of the current MDE is at least 3 months.
- Has a Montgomery Ã…sberg Depression Rating Scale total score greater than or equal to 30.
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
You may not qualify if:
- Has received any investigational compound less than 30 days before Screening or 5 half-lives prior to Screening, whichever is longer.
- Has received Lu AA21004 in a previous clinical study.
- Has 1 or more the following:
- Any current psychiatric disorder other than major depressive disorder as defined in the DSM-IV-TR (as assessed by the Mini International Neuropsychiatric Interview)
- Current or past 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.
- Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR.
- Presence or history of a clinically significant neurological disorder (including epilepsy).
- Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
- Any Axis II disorder that might compromise the study.
- Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
- Narcotic analgesics
- Nonsteroidal anti-inflammatory drugs
- Rifampin
- Macrolide antibiotics
- Hormones (only thyroid hormone replacement, contraceptives \[oral, patch\], estrogen and progesterone replacement therapy are allowed in chronic use)
- +20 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
- H. Lundbeck A/Scollaborator
Study Sites (33)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Cerritos, California, United States
Unknown Facility
Encino, California, United States
Unknown Facility
Fresno, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Farmington, Connecticut, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
North Miami, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Hoffman Estate, Illinois, United States
Unknown Facility
Lafayette, Indiana, United States
Unknown Facility
Valparaiso, Indiana, United States
Unknown Facility
Shreveport, Louisiana, United States
Unknown Facility
Saint Paul, Minnesota, United States
Unknown Facility
Florissant, Missouri, United States
Unknown Facility
Saint Charles, Missouri, United States
Unknown Facility
Las Vegas, Nevada, United States
Unknown Facility
Rochester, New York, United States
Unknown Facility
Dayton, Ohio, United States
Unknown Facility
Toledo, Ohio, United States
Unknown Facility
Tulsa, Oklahoma, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Lincoln, Rhode Island, United States
Unknown Facility
North Charleston, South Carolina, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Lake Jackson, Texas, United States
Unknown Facility
Wichita Falls, Texas, United States
Unknown Facility
Brown Deer, Wisconsin, United States
Unknown Facility
Middleton, Wisconsin, United States
Unknown Facility
Hull, Quebec, Canada
Unknown Facility
Mexico City, Mexico
Unknown Facility
San Luis Potosà City, Mexico
Related Publications (1)
Jain R, Mahableshwarkar AR, Jacobsen PL, Chen Y, Thase ME. A randomized, double-blind, placebo-controlled 6-wk trial of the efficacy and tolerability of 5 mg vortioxetine in adults with major depressive disorder. Int J Neuropsychopharmacol. 2013 Mar;16(2):313-21. doi: 10.1017/S1461145712000727. Epub 2012 Sep 11.
PMID: 22963932RESULT
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 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2008
First Posted
May 6, 2008
Study Start
April 1, 2008
Primary Completion
November 1, 2008
Study Completion
November 1, 2008
Last Updated
December 13, 2013
Results First Posted
December 13, 2013
Record last verified: 2013-10