Vortioxetine, 5, 10, and 20 mg, Relapse Prevention Study in Adults With Major Depressive Disorder (MDD)
A Randomized, Double-Blind, Placebo-Controlled, Phase 4, Relapse Prevention Study Evaluating the Efficacy and Safety of Vortioxetine (5, 10 and 20 mg) in Adults With Major Depressive Disorder
2 other identifiers
interventional
1,106
1 country
79
Brief Summary
The purpose of this study is to evaluate the efficacy of vortioxetine (5, 10, and 20 mg) versus placebo during the first 28 weeks of the 32-week double-blind treatment period in the prevention of relapse in participants with MDD who responded to acute treatment with vortioxetine 10 mg.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 major-depressive-disorder
Started Feb 2015
Longer than P75 for phase_4 major-depressive-disorder
79 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
February 10, 2015
CompletedFirst Submitted
Initial submission to the registry
February 20, 2015
CompletedFirst Posted
Study publicly available on registry
February 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 25, 2019
CompletedResults Posted
Study results publicly available
April 17, 2020
CompletedJanuary 6, 2021
December 1, 2020
4.1 years
February 20, 2015
April 3, 2020
December 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time From Randomization to Relapse of Major Depressive Disorder During the First 28 Weeks of the 32-Week Double-Blind Treatment Period
Relapse was defined as either 1) MADRS Score ≥22, 2) lack of efficacy as determined by the investigator or 3) other unsatisfactory treatment response judged by the investigator. Time to relapse was defined as date of relapse - date of randomization + 1 (where date of relapse is the date of last dose, or date of last contact if date of last dose is missing, for participant with a relapse). Participants without relapse were censored at date of withdrawal or date of Week 28 visit, whichever was earliest. MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (i.e., apparent sadness, reported sadness, inner tension, etc.) rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score ranges from 0 to 60. Higher scores indicate greater severity of symptoms. The inter-quartile range (IQR) was 25th percentile to 75th percentile.
From date of double-blind randomization (Week 16) up to relapse or first 28 weeks of Double-blind Period which occurs first (Up to Week 44)
Secondary Outcomes (4)
Change From Baseline in Montgomery-Ă…sberg Depression Rating Scale (MADRS) Total Score
Double-blind Baseline (BL) II and Double-blind Period: Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32
Change From Baseline in Clinical Global Impression Scale-Severity (CGI-S) Score at Each Week Assessed
Double-blind Baseline (BL) II and Double-blind Period: Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32
Clinical Global Impression Scale-Global Improvement Scale (CGI-I) Score
Week 32
Time From Randomization to Relapse of Major Depressive Disorder During the Entire 32-Week Double-Blind Treatment Period
From date of double-blind randomization (Week 16) up to relapse or 32 weeks of Double-blind Period which occurs first (Up to Week 44)
Study Arms (5)
Open-label: Vortioxetine 10 mg
EXPERIMENTALVortioxetine 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.
Double-blind: Placebo
PLACEBO COMPARATORFollowing 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.
Double-blind: Vortioxetine 5 mg
EXPERIMENTALFollowing 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.
Double-blind: Vortioxetine 10 mg
EXPERIMENTALFollowing 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.
Double-blind: Vortioxetine 20 mg
PLACEBO COMPARATORFollowing 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.
Interventions
Vortioxetine capsules
Eligibility Criteria
You may qualify if:
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- 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.
- 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).
- Reported duration of the current episode is ≥8 weeks and ≤18months.
- Had at least 2 other major depressive episodes (MDEs) before the current episode.
- Has a Montgomery-Ă…sberg Depression Rating Scale (MADRS) total score ≥26 at the Screening and Baseline I visits.
- Is a man or woman aged 18 to 75 years, inclusive.
- 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.
You may not qualify if:
- Has received any investigational compound within 30 days prior to screening or 5 half-lives prior to screening, whichever is longer.
- Has previously or is currently participating in this study.
- 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.
- Has one or more of the following:
- 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.
- 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.
- 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.)
- Presence or history of a clinically significant neurological disorder (including epilepsy) as determined by the investigator.
- Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
- Any Axis II disorder as defined by DSM-IV-TR 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 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.
- Has received electroconvulsive therapy, vagal nerve stimulation, or repetitive transcranial magnetic stimulation within 6 months prior to Screening.
- 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).
- 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.
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (79)
NoesisPharma
Phoenix, Arizona, 85032, United States
SW Biomedical Research, LLC
Tucson, Arizona, 85712, United States
CNS Research Science, Inc.
Cerritos, California, 90703, United States
Collaborative Neuroscience Network, LLC
Garden Grove, California, 92845, United States
Irvine Center for Clinical Research, Inc.
Irvine, California, 92614, United States
Synergy Clinical Research of Escondido
Lemon Grove, California, 91945, United States
Pharmacology Research Institute
Los Alamitos, California, 90720, United States
Pacific Institute of Medical Research
Los Angeles, California, 90024, United States
CNRI - Los Angeles, LLC
Pico Rivera, California, 90660, United States
CNRI - San Diego, LLC
San Diego, California, 92102, United States
Artemis Institute for Clinical Research, LLC
San Diego, California, 92103, United States
University of California San Diego Medical Center
San Diego, California, 92103, United States
Pasadena Research Institute
San Gabriel, California, 91776, United States
Collaborative Neuroscience Network, LLC
Torrance, California, 90502, United States
Research Center for Clinical Studies, Inc.
Norwalk, Connecticut, 06851, United States
CNS Clinical Research Group
Coral Springs, Florida, 33067, United States
Gulfcoast Medical Research Center, LLC
Fort Myers, Florida, 33912, United States
MD Clinical
Hallandale, Florida, 33009, United States
Indago Research & Health Center, Inc.
Hialeah, Florida, 33012, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256, United States
Meridien Research
Maitland, Florida, 32751, United States
Sarkis Clinical Trials - Parent
Ocala, Florida, 34474, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801, United States
Stedman Clinical Trials, LLC
Tampa, Florida, 33613, United States
Janice L. Miller, M.D., PA d/b/a Janus Center for Psychiatric Reseach
West Palm Beach, Florida, 33407, United States
Radiant Research, Inc.
Atlanta, Georgia, 30328, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30331, United States
iResearch Atlanta, LLC
Decatur, Georgia, 30030, United States
Alexian Brothers Center for Psychiatric Research
Arlington Heights, Illinois, 60005, United States
Rush St Lukes Presbyterian Medical Center
Chicago, Illinois, 60612, United States
Capstone Clinical Research, Inc.
Libertyville, Illinois, 60048, United States
Goldpoint Clinical Research, LLC
Indianapolis, Indiana, 46260, United States
Buynak Clinical Research
Valparaiso, Indiana, 46383, United States
Phoenix Medical Research, Inc.
Prairie Village, Kansas, 66208, United States
Heartland Research Associates, LLC
Wichita, Kansas, 67207, United States
Lake Charles Clinical Trials, LLC
Lake Charles, Louisiana, 70629, United States
Pharmasite Research, Inc.
Baltimore, Maryland, 21208, United States
Potomac Grove Clinical Research Center
Gaithersburg, Maryland, 20877, United States
Boston Clinical Trials & Medical Research
Boston, Massachusetts, 02131, United States
Univ. of Massachussetts Memorial Health Care Systems
Worcester, Massachusetts, 01605-2610, United States
Altea Research Institute
Las Vegas, Nevada, 89102, United States
Hassman Research Institute
Berlin, New Jersey, 08009, United States
Erie County Medical Center Corporation
Buffalo, New York, 14215, United States
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516, United States
CNS Research Science, Inc.
Jamaica, New York, 11432, United States
Village Clinical Research, Inc.
New York, New York, 10003, United States
Manhattan Behavioral Medicine, PLLC
New York, New York, 10022, United States
Finger Lakes Clinical Research
Rochester, New York, 14618, United States
Montefiore Medical Center PRIME
The Bronx, New York, 10467, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Clinical Trials of America, Inc
Hickory, North Carolina, 28601, United States
NorthCoast Clinical Trials, Inc.
Beachwood, Ohio, 44122, United States
Patient Priority Clinical Sites, LLC
Cincinnati, Ohio, 45215, United States
IPS Research Company
Oklahoma City, Oklahoma, 73103, United States
Cutting Edge Research Group, Inc.
Oklahoma City, Oklahoma, 73116, United States
Summit Research Network (Oregon) Inc.
Portland, Oregon, 97210, United States
Oregon Center for Clinical Investigations, Inc.
Portland, Oregon, 97214, United States
Suburban Research Associates
Media, Pennsylvania, 19063, United States
Keystone Clinical Studies, LLC
Norristown, Pennsylvania, 19403, United States
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, 19104, United States
Lincoln Research
Lincoln, Rhode Island, 02865, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29401, United States
Coastal Carolina Research Center, Inc
Mt. Pleasant, South Carolina, 29464, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119, United States
FutureSearch Clinical Trials, L.P.
Austin, Texas, 78731, United States
BioBehavioral Research of Austin
Austin, Texas, 78759, United States
FutureSearch Trials of Dallas, LP
Dallas, Texas, 75231, United States
Bayou City Research, Ltd.
Houston, Texas, 77007, United States
Houston Clinical Trials, LLC
Houston, Texas, 77098, United States
Pillar Clinical Research, LLC
Richardson, Texas, 75080, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229, United States
Radiant Research, Inc.
Murray, Utah, 84123, United States
Neuropsychiatric Associates
Woodstock, Vermont, 05091, United States
University of Virginia Health System
Charlottesville, Virginia, 22903, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298-5054, United States
Eastside Therapeutic Resource
Everett, Washington, 98201, United States
Summit Research Network (Seattle), LLC
Seattle, Washington, 98104, United States
Frontier Institute
Spokane, Washington, 99204, United States
Northbrooke Research Center
Brown Deer, Wisconsin, 53223, United States
Related Publications (1)
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.
PMID: 35131363DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- 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 4
- 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
February 20, 2015
First Posted
February 26, 2015
Study Start
February 10, 2015
Primary Completion
March 1, 2019
Study Completion
April 25, 2019
Last Updated
January 6, 2021
Results First Posted
April 17, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.