Vortioxetine, 5, 10, and 20 mg, Relapse Prevention Study in Adults With Major Depressive Disorder (MDD)
NCT ID: NCT02371980
Last Updated: 2021-01-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1106 participants
INTERVENTIONAL
2015-02-10
2019-04-25
Brief Summary
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Detailed Description
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The study will enroll approximately 1100 participants. All participants will receive vortioxetine 10 mg open-label for the first 16 weeks of the study. Participants who meet the appropriate MDD response criteria from the Week 8 Visit through Week 16 Visit will be eligible for randomization into the double-blind treatment period. Participants will be randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
* Vortioxetine 5 mg
* Vortioxetine 10 mg
* Vortioxetine 20 mg
* Placebo (dummy inactive pill) - this is a capsule that looks like the study drug but has no active ingredient
All participants will be asked to take one capsule at the same time each day throughout the study.
This multi-center trial will be conducted in the United States. The overall time to participate in this study is up to 55 weeks. Participants will make 19 visits to the clinic, and will be contacted by telephone 4 weeks after last dose of study drug for a follow-up assessment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Open-label: Vortioxetine 10 mg
Vortioxetine 10 mg, capsules, orally, once, daily (QD) up to 8 weeks. Participants who achieved response (defined as a ≥50% reduction in Montgomery Asberg Depression Rating Scale (MADRS) total score from Baseline) continued to receive vortioxetine 10 mg, capsules, orally, QD for up to Week 16 (stabilization period) in the Open-label Period.
Vortioxetine
Vortioxetine capsules
Double-blind: Placebo
Following Open-label Period, participants who achieved remission criteria (defined as MADRS total score ≤12 at Weeks 14 and 16) were randomized to receive vortioxetine placebo-matching capsules, orally, QD from Week 17 up to Week 44 in the Double-blind Period.
Placebo
Vortioxetine placebo-matching capsules
Double-blind: Vortioxetine 5 mg
Following Open-label Period, participants who achieved remission criteria (defined as MADRS total score ≤12 at Weeks 14 and 16) were randomized to receive vortioxetine 5 mg, capsules, orally, QD from Week 17 up to Week 44 in the Double-blind Period.
Vortioxetine
Vortioxetine capsules
Double-blind: Vortioxetine 10 mg
Following Open-label Period, participants who achieved remission criteria (defined as MADRS total score ≤12 at Weeks 14 and 16) were randomized to receive vortioxetine 10 mg, capsules, orally, QD from Week 17 up to Week 44 in the Double-blind Period.
Vortioxetine
Vortioxetine capsules
Double-blind: Vortioxetine 20 mg
Following Open-label Period, participants who achieved remission criteria (defined as MADRS total score ≤12 at Weeks 14 and 16) were randomized to receive vortioxetine 20 mg, capsules, orally, QD from Week 17 up to Week 44 in the Double-blind Period.
Vortioxetine
Vortioxetine capsules
Interventions
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Vortioxetine
Vortioxetine capsules
Placebo
Vortioxetine placebo-matching capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
3. Suffers from recurrent major depressive disorder (MDD) as the primary diagnosis according to Diagnostic \& Statistical Manual of Mental Disorders, 4th Edition - Text Revision (DSM-IV-TR) criteria (classification code 296.3x), and the current episode is confirmed by the Mini International Neuropsychiatric Interview (MINI).
4. Reported duration of the current episode is ≥8 weeks and ≤18months.
5. Had at least 2 other major depressive episodes (MDEs) before the current episode.
6. Has a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥26 at the Screening and Baseline I visits.
7. Is a man or woman aged 18 to 75 years, inclusive.
8. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to routinely use adequate contraception from signing of the informed consent throughout the duration of the study and for 30 days after the last dose.
Exclusion Criteria
2. Has previously or is currently participating in this study.
3. Has participated in 2 or more clinical studies in the year prior to screening, or has participated in a clinical trial for a psychiatric condition that is exclusionary per this protocol.
4. Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
5. Has one or more of the following:
1. Any current psychiatric disorder which is the primary focus of treatment other than MDD as defined in the DSM-IV-TR, and assessed by the MINI.
2. Current or history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including schizoaffective disorder, major depression with psychotic features, bipolar depression with psychotic features, obsessive compulsive disorder (OCD), mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
3. Current diagnosis or history of alcohol or other substance abuse or dependence (excluding nicotine or caffeine) as defined in the DSM-IV-TR that has not been in full and sustained remission for at least 3 months from the day of screening (Participant must also have negative urine drug screen at Screening and Baseline I.)
4. Presence or history of a clinically significant neurological disorder (including epilepsy) as determined by the investigator.
5. Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
6. Any Axis II disorder as defined by DSM-IV-TR that might compromise the study.
6. 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.
7. Has a history of lack of response to previous adequate treatment with vortioxetine for any MDD episode with adequate treatment considered to be known dose of vortioxetine in the approved recommended dose range for at least 6 weeks duration.
8. Has received electroconvulsive therapy, vagal nerve stimulation, or repetitive transcranial magnetic stimulation within 6 months prior to Screening.
9. Has started receiving formal cognitive or behavioral therapy, systematic psychotherapy within 30 days from screening or plans to initiate such therapy during the study (supportive therapy, marital therapy and bereavement counseling are allowed).
10. Has a significant risk of suicide according to the investigator's clinical judgment or has a score ≥5 on item 10 (suicidal thoughts) of the MADRS or has made a suicide attempt in the previous 6 months.
11. Is required to take excluded medications or it is anticipated that the participant will require treatment with at least 1 of the disallowed concomitant medications during the study.
12. 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 protocol fibromyalgia, obstructive sleep apnea, chronic pain diagnosis, and morbid obesity (BMI of \> 40) are considered unstable due to the potential impact on assessment of the primary endpoint.
13. Has a known history of or currently has increased intraocular pressure or is at risk of acute narrow-angle glaucoma.
14. Has 1 or more laboratory value outside the normal range, based on the blood or urine samples taken at the Screening Visit, that are considered by the investigator to be clinically significant; or the participant 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 serum total bilirubin value \>1.5 xULN.
3. A serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value \>2 xULN.
15. Has glycosylated hemoglobin (HbA1C) ≥7% at screening and no prior diagnosis of diabetes and/or treatment for diabetes. NOTE: Participants with known stable diabetes are not excluded.
16. Has a thyroid stimulating hormone (TSH) value outside the normal range at the Screening Visit that is deemed clinically significant by the investigator. NOTE: Free T4 will be checked if TSH is out of range. If free T4 is abnormal the participant will be excluded.
17. Has clinically significant abnormal vital signs as determined by the investigator.
18. Has an abnormal electrocardiogram (ECG) as determined by the central reader and confirmed as clinically significant by the investigator.
19. Is positive for Hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or has a history of human immunodeficiency virus (HIV) infection.
20. Has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability or efficacy.
21. The participant, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
22. Has a history of hypersensitivity or allergies to vortioxetine.
23. If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period.
24. The participant is considered to be treatment resistant, eg, the participant has not responded to adequate monotherapy treatments of at least 6 weeks' duration, or has only responded to combination or augmentation therapy.
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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NoesisPharma
Phoenix, Arizona, United States
SW Biomedical Research, LLC
Tucson, Arizona, United States
CNS Research Science, Inc.
Cerritos, California, United States
Collaborative Neuroscience Network, LLC
Garden Grove, California, United States
Irvine Center for Clinical Research, Inc.
Irvine, California, United States
Synergy Clinical Research of Escondido
Lemon Grove, California, United States
Pharmacology Research Institute
Los Alamitos, California, United States
Pacific Institute of Medical Research
Los Angeles, California, United States
CNRI - Los Angeles, LLC
Pico Rivera, California, United States
CNRI - San Diego, LLC
San Diego, California, United States
Artemis Institute for Clinical Research, LLC
San Diego, California, United States
University of California San Diego Medical Center
San Diego, California, United States
Pasadena Research Institute
San Gabriel, California, United States
Collaborative Neuroscience Network, LLC
Torrance, California, United States
Research Center for Clinical Studies, Inc.
Norwalk, Connecticut, United States
CNS Clinical Research Group
Coral Springs, Florida, United States
Gulfcoast Medical Research Center, LLC
Fort Myers, Florida, United States
MD Clinical
Hallandale, Florida, United States
Indago Research & Health Center, Inc.
Hialeah, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Meridien Research
Maitland, Florida, United States
Sarkis Clinical Trials - Parent
Ocala, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Stedman Clinical Trials, LLC
Tampa, Florida, United States
Janice L. Miller, M.D., PA d/b/a Janus Center for Psychiatric Reseach
West Palm Beach, Florida, United States
Radiant Research, Inc.
Atlanta, Georgia, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
iResearch Atlanta, LLC
Decatur, Georgia, United States
Alexian Brothers Center for Psychiatric Research
Arlington Heights, Illinois, United States
Rush St Lukes Presbyterian Medical Center
Chicago, Illinois, United States
Capstone Clinical Research, Inc.
Libertyville, Illinois, United States
Goldpoint Clinical Research, LLC
Indianapolis, Indiana, United States
Buynak Clinical Research
Valparaiso, Indiana, United States
Phoenix Medical Research, Inc.
Prairie Village, Kansas, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Lake Charles Clinical Trials, LLC
Lake Charles, Louisiana, United States
Pharmasite Research, Inc.
Baltimore, Maryland, United States
Potomac Grove Clinical Research Center
Gaithersburg, Maryland, United States
Boston Clinical Trials & Medical Research
Boston, Massachusetts, United States
Univ. of Massachussetts Memorial Health Care Systems
Worcester, Massachusetts, United States
Altea Research Institute
Las Vegas, Nevada, United States
Hassman Research Institute
Berlin, New Jersey, United States
Erie County Medical Center Corporation
Buffalo, New York, United States
Neurobehavioral Research, Inc.
Cedarhurst, New York, United States
CNS Research Science, Inc.
Jamaica, New York, United States
Village Clinical Research, Inc.
New York, New York, United States
Manhattan Behavioral Medicine, PLLC
New York, New York, United States
Finger Lakes Clinical Research
Rochester, New York, United States
Montefiore Medical Center PRIME
The Bronx, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Clinical Trials of America, Inc
Hickory, North Carolina, United States
NorthCoast Clinical Trials, Inc.
Beachwood, Ohio, United States
Patient Priority Clinical Sites, LLC
Cincinnati, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
Cutting Edge Research Group, Inc.
Oklahoma City, Oklahoma, United States
Summit Research Network (Oregon) Inc.
Portland, Oregon, United States
Oregon Center for Clinical Investigations, Inc.
Portland, Oregon, United States
Suburban Research Associates
Media, Pennsylvania, United States
Keystone Clinical Studies, LLC
Norristown, Pennsylvania, United States
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, United States
Lincoln Research
Lincoln, Rhode Island, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Coastal Carolina Research Center, Inc
Mt. Pleasant, South Carolina, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States
FutureSearch Clinical Trials, L.P.
Austin, Texas, United States
BioBehavioral Research of Austin
Austin, Texas, United States
FutureSearch Trials of Dallas, LP
Dallas, Texas, United States
Bayou City Research, Ltd.
Houston, Texas, United States
Houston Clinical Trials, LLC
Houston, Texas, United States
Pillar Clinical Research, LLC
Richardson, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Radiant Research, Inc.
Murray, Utah, United States
Neuropsychiatric Associates
Woodstock, Vermont, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States
Eastside Therapeutic Resource
Everett, Washington, United States
Summit Research Network (Seattle), LLC
Seattle, Washington, United States
Frontier Institute
Spokane, Washington, United States
Northbrooke Research Center
Brown Deer, Wisconsin, United States
Countries
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References
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Thase ME, Jacobsen PL, Hanson E, Xu R, Tolkoff M, Murthy NV. Vortioxetine 5, 10, and 20 mg significantly reduces the risk of relapse compared with placebo in patients with remitted major depressive disorder: The RESET study. J Affect Disord. 2022 Apr 15;303:123-130. doi: 10.1016/j.jad.2022.02.002. Epub 2022 Feb 5.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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U1111-1161-4956
Identifier Type: REGISTRY
Identifier Source: secondary_id
LuAA21004_402
Identifier Type: -
Identifier Source: org_study_id
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