Safety and Efficacy Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder
NCT ID: NCT01179516
Last Updated: 2013-12-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
469 participants
INTERVENTIONAL
2010-08-31
2012-06-30
Brief Summary
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Detailed Description
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The study enrolled 469 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):
* Vortioxetine 10 mg
* Vortioxetine 15 mg
* Placebo (dummy inactive capsule) - this was a capsule that looked like the study drug but had no active ingredient.
All participants were asked to take one capsule at the same time each day throughout the study.
This multi-center trial was conducted in the United States. The overall time to participate in this study was up to 14 weeks. Participants made 7 visits to the clinic, and were contacted by telephone 4 weeks after the last dose of study drug for a follow-up assessment.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Placebo
Vortioxetine placebo-matching capsules
Vortioxetine 10 mg
Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
Vortioxetine
Encapsulated vortioxetine immediate release tablets
Vortioxetine 15 mg
Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
Vortioxetine
Encapsulated vortioxetine immediate release tablets
Interventions
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Vortioxetine
Encapsulated vortioxetine immediate release tablets
Placebo
Vortioxetine placebo-matching capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The reported duration of the current MDE is at least 3 months.
* Has a Montgomery Åsberg Depression Rating Scale (MADRS) total score of 26 or greater at Screening and Baseline Visits.
* Has a Clinical Global Impression - Severity of Illness (CGI-S) score of 4 or greater at Screening and Baseline Visits.
Exclusion Criteria
* Has received Lu AA21004 in a previous clinical study.
* Has 1 or more the following:
1. Any current psychiatric disorder other than MDD as defined in the DSM-IV-TR .
2. Current 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.
3. Diagnosis of alcohol or other substance abuse or dependence (excluding nicotine or caffeine) as defined in the DSM-IV-TR that had not been in sustained full remission for at least 2 years prior to Screening.
4. Presence or history of a clinically significant neurological disorder (including epilepsy).
5. Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
6. Any Axis II disorder that might compromise the study.
* The current depressive symptoms of the patient were considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.
* Has received electroconvulsive therapy, vagal nerve stimulation, or repetitive transcranial magnetic stimulation within 6 months prior to Screening.
* Was currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or planned to initiate such therapy during the study.
* Has a significant risk of suicide according to the investigator's clinical judgment or had a score ≥5 on item 10 (suicidal thoughts) of the MADRS or had made a suicide attempt in the previous 6 months.
* Was required to take excluded medications or it was anticipated that would require treatment with at least 1 of the disallowed concomitant medications during the study.
* Has a clinically significant unstable illness, for example hepatic impairment or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, hematological, infectious, dermatological disorder or metabolic disturbance. NOTE: For the purposes of this study, the following conditions were considered unstable due to the potential impact on assessment of MDD response: pain disorder, chronic fatigue syndrome, fibromyalgia, and obstructive sleep apnea.
* Has 1 or more laboratory value outside the normal range, based on the blood or urine samples taken at the Screening Visit, that were considered by the investigator to be clinically significant; or the patient has any of the following values at the Screening Visit:
1. A serum creatinine value \>1.5 times the upper limits of normal (× ULN).
2. A total serum total bilirubin value \>1.5 × ULN.
3. A serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value \>2 × ULN.
* Has a thyroid stimulating hormone value outside the normal range.
* Has clinically significant abnormal vital signs.
* Has an abnormal electrocardiogram.
18 Years
75 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director, Clinical Science
Role: STUDY_DIRECTOR
Takeda
Locations
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Little Rock, Arkansas, United States
Carson, California, United States
Cerritos, California, United States
El Centro, California, United States
Fresno, California, United States
Glendale, California, United States
Los Angeles, California, United States
Oakland, California, United States
Oceanside, California, United States
San Diego, California, United States
Santa Ana, California, United States
Sherman Oaks, California, United States
Stanford, California, United States
Upland, California, United States
Denver, Colorado, United States
Hartford, Connecticut, United States
Hockessin, Delaware, United States
Fort Walton Beach, Florida, United States
Kissimmee, Florida, United States
Miami, Florida, United States
Pompano Beach, Florida, United States
Atlanta, Georgia, United States
Hoffman Estates, Illinois, United States
Naperville, Illinois, United States
Oak Brook, Illinois, United States
Indianapolis, Indiana, United States
Lafayette, Indiana, United States
Newburgh, Indiana, United States
Prarie Ridge, Kansas, United States
Wichita, Kansas, United States
Baltimore, Maryland, United States
Fall River, Massachusetts, United States
Watertown, Massachusetts, United States
Clinton Township, Michigan, United States
St Louis, Missouri, United States
Las Vegas, Nevada, United States
Nashua, New Hampshire, United States
Albuquerque, New Mexico, United States
Staten Island, New York, United States
Avon Lake, Ohio, United States
Beachwood, Ohio, United States
Canton, Ohio, United States
Garfield Heights, Ohio, United States
Toledo, Ohio, United States
Oklahoma City, Oklahoma, United States
Salem, Oregon, United States
Allentown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Lincoln, Rhode Island, United States
Columbia, South Carolina, United States
Franklin, Tennessee, United States
Dallas, Texas, United States
DeSoto, Texas, United States
Houston, Texas, United States
Lake Jackson, Texas, United States
San Antonio, Texas, United States
The Woodlands, Texas, United States
Salt Lake City, Utah, United States
Roanoke, Virginia, United States
Milwaukee, Wisconsin, United States
Countries
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References
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Mahableshwarkar AR, Jacobsen PL, Serenko M, Chen Y, Trivedi MH. A randomized, double-blind, placebo-controlled study of the efficacy and safety of 2 doses of vortioxetine in adults with major depressive disorder. J Clin Psychiatry. 2015 May;76(5):583-91. doi: 10.4088/JCP.14m09337.
Other Identifiers
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U1111-1116-3223
Identifier Type: REGISTRY
Identifier Source: secondary_id
SU-06032011-7846
Identifier Type: REGISTRY
Identifier Source: secondary_id
LuAA21004_317
Identifier Type: -
Identifier Source: org_study_id