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Major Depressive DisorderPhase 4NCT02371980

Vortioxetine, 5, 10, and 20 mg, Relapse Prevention Study in Adults With Major Depressive Disorder (MDD)

A Phase 4 study testing Vortioxetine in people with Major Depressive Disorder, run by Takeda at 79 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Major Depressive Disorder
What is being tested?
Vortioxetine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,106 participants
Where
79 sitesUnited States
Study dates
10 Feb 2015to 25 Apr 2019
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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-Åsberg 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.

Who cannot join

  • 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.
  • 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.
  • 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.
Show all 34Show fewer
  • 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.
  • 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.
  • 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.
  • Has a known history of or currently has increased intraocular pressure or is at risk of acute narrow-angle glaucoma.
  • 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:
  • A serum creatinine value >1.5 times the upper limits of normal (ULN).
  • A serum total bilirubin value >1.5 xULN.
  • A serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value >2 xULN.
  • 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.
  • 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.
  • Has clinically significant abnormal vital signs as determined by the investigator.
  • Has an abnormal electrocardiogram (ECG) as determined by the central reader and confirmed as clinically significant by the investigator.
  • Is positive for Hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or has a history of human immunodeficiency virus (HIV) infection.
  • Has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability or efficacy.
  • The participant, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
  • Has a history of hypersensitivity or allergies to vortioxetine.
  • 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.
  • 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.

Trial locations and contacts

79 sites in 1 country.

79 sites in 1 country

United States79 sites

  • Alexian Brothers Center for Psychiatric Research

    Arlington Heights, Illinois, 60005

  • Radiant Research, Inc.

    Atlanta, Georgia, 30328

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30331

  • FutureSearch Clinical Trials, L.P.

    Austin, Texas, 78731

  • BioBehavioral Research of Austin

    Austin, Texas, 78759

  • Pharmasite Research, Inc.

    Baltimore, Maryland, 21208

  • NorthCoast Clinical Trials, Inc.

    Beachwood, Ohio, 44122

  • Hassman Research Institute

    Berlin, New Jersey, 08009

  • Boston Clinical Trials & Medical Research

    Boston, Massachusetts, 02131

  • Northbrooke Research Center

    Brown Deer, Wisconsin, 53223

  • Erie County Medical Center Corporation

    Buffalo, New York, 14215

  • Neurobehavioral Research, Inc.

    Cedarhurst, New York, 11516

  • CNS Research Science, Inc.

    Cerritos, California, 90703

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29401

  • University of Virginia Health System

    Charlottesville, Virginia, 22903

  • Rush St Lukes Presbyterian Medical Center

    Chicago, Illinois, 60612

  • Patient Priority Clinical Sites, LLC

    Cincinnati, Ohio, 45215

  • CNS Clinical Research Group

    Coral Springs, Florida, 33067

  • FutureSearch Trials of Dallas, LP

    Dallas, Texas, 75231

  • iResearch Atlanta, LLC

    Decatur, Georgia, 30030

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Eastside Therapeutic Resource

    Everett, Washington, 98201

  • Gulfcoast Medical Research Center, LLC

    Fort Myers, Florida, 33912

  • Potomac Grove Clinical Research Center

    Gaithersburg, Maryland, 20877

  • Collaborative Neuroscience Network, LLC

    Garden Grove, California, 92845

  • MD Clinical

    Hallandale, Florida, 33009

  • Indago Research & Health Center, Inc.

    Hialeah, Florida, 33012

  • Clinical Trials of America, Inc

    Hickory, North Carolina, 28601

  • Bayou City Research, Ltd.

    Houston, Texas, 77007

  • Houston Clinical Trials, LLC

    Houston, Texas, 77098

  • Goldpoint Clinical Research, LLC

    Indianapolis, Indiana, 46260

  • Irvine Center for Clinical Research, Inc.

    Irvine, California, 92614

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida, 32256

  • CNS Research Science, Inc.

    Jamaica, New York, 11432

  • Lake Charles Clinical Trials, LLC

    Lake Charles, Louisiana, 70629

  • Altea Research Institute

    Las Vegas, Nevada, 89102

  • Synergy Clinical Research of Escondido

    Lemon Grove, California, 91945

  • Capstone Clinical Research, Inc.

    Libertyville, Illinois, 60048

  • Lincoln Research

    Lincoln, Rhode Island, 02865

  • Pharmacology Research Institute

    Los Alamitos, California, 90720

  • Pacific Institute of Medical Research

    Los Angeles, California, 90024

  • Meridien Research

    Maitland, Florida, 32751

  • Suburban Research Associates

    Media, Pennsylvania, 19063

  • Clinical Neuroscience Solutions, Inc.

    Memphis, Tennessee, 38119

  • Coastal Carolina Research Center, Inc

    Mt. Pleasant, South Carolina, 29464

  • Radiant Research, Inc.

    Murray, Utah, 84123

  • Village Clinical Research, Inc.

    New York, New York, 10003

  • Manhattan Behavioral Medicine, PLLC

    New York, New York, 10022

  • Keystone Clinical Studies, LLC

    Norristown, Pennsylvania, 19403

  • Research Center for Clinical Studies, Inc.

    Norwalk, Connecticut, 06851

  • Sarkis Clinical Trials - Parent

    Ocala, Florida, 34474

  • IPS Research Company

    Oklahoma City, Oklahoma, 73103

  • Cutting Edge Research Group, Inc.

    Oklahoma City, Oklahoma, 73116

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida, 32801

  • University of Pennsylvania School of Medicine

    Philadelphia, Pennsylvania, 19104

  • NoesisPharma

    Phoenix, Arizona, 85032

  • CNRI - Los Angeles, LLC

    Pico Rivera, California, 90660

  • Summit Research Network (Oregon) Inc.

    Portland, Oregon, 97210

  • Oregon Center for Clinical Investigations, Inc.

    Portland, Oregon, 97214

  • Phoenix Medical Research, Inc.

    Prairie Village, Kansas, 66208

  • Pillar Clinical Research, LLC

    Richardson, Texas, 75080

  • Virginia Commonwealth University Medical Center

    Richmond, Virginia, 23298-5054

  • Finger Lakes Clinical Research

    Rochester, New York, 14618

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas, 78229

  • CNRI - San Diego, LLC

    San Diego, California, 92102

  • Artemis Institute for Clinical Research, LLC

    San Diego, California, 92103

  • University of California San Diego Medical Center

    San Diego, California, 92103

  • Pasadena Research Institute

    San Gabriel, California, 91776

  • Summit Research Network (Seattle), LLC

    Seattle, Washington, 98104

  • Frontier Institute

    Spokane, Washington, 99204

  • Stedman Clinical Trials, LLC

    Tampa, Florida, 33613

  • Montefiore Medical Center PRIME

    The Bronx, New York, 10467

  • Collaborative Neuroscience Network, LLC

    Torrance, California, 90502

  • SW Biomedical Research, LLC

    Tucson, Arizona, 85712

  • Buynak Clinical Research

    Valparaiso, Indiana, 46383

  • Janice L. Miller, M.D., PA d/b/a Janus Center for Psychiatric Reseach

    West Palm Beach, Florida, 33407

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67207

  • Neuropsychiatric Associates

    Woodstock, Vermont, 05091

  • Univ. of Massachussetts Memorial Health Care Systems

    Worcester, Massachusetts, 01605-2610

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

The drug being tested in this study is called vortioxetine. Vortioxetine is being tested for the prevention of relapse in adults with major depressive disorder (MDD) who respond to daily treatment with vortioxetine. This study will look at relapse rates of MDD in people who take vortioxetine.

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.

Being tested
Vortioxetine, Placebo
Keywords
Drug therapy
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VortioxetineDrug

    Also called LuAA21004

    Vortioxetine capsules

  • PlaceboDrug

    Vortioxetine placebo-matching capsules

Study groups in NCT02371980
Study groupRoleWhat they receive
Open-label: Vortioxetine 10 mgExperimentalVortioxetine 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.
Receives: Drug: Vortioxetine
Double-blind: PlaceboPlacebo 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.
Receives: Drug: Placebo
Double-blind: Vortioxetine 5 mgExperimentalFollowing 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.
Receives: Drug: Vortioxetine
Double-blind: Vortioxetine 10 mgExperimentalFollowing 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.
Receives: Drug: Vortioxetine
Double-blind: Vortioxetine 20 mgPlacebo 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.
Receives: Drug: Vortioxetine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score

    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 range from 0 to 60. Higher score indicates greater severity of symptoms. Baseline II is defined as the last non-missing observation prior to the first dose of double-blind study drug. Mixed model for repeated measures (MMRM) was used for analyses.

    Measured: Double-blind Baseline (BL) II and Double-blind Period: Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32

  2. Change From Baseline in Clinical Global Impression Scale-Severity (CGI-S) Score at Each Week Assessed

    The CGI-S is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with participant who have the same diagnosis. Considering total clinical experience, a participant was assessed on severity of mental illness on the following scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=extremely ill. Baseline II is defined as the last non-missing observation prior to the first dose of double-blind study drug. MMRM was used for analyses.

    Measured: Double-blind Baseline (BL) II and Double-blind Period: Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32

  3. Clinical Global Impression Scale-Global Improvement Scale (CGI-I) Score

    The CGI-I scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale where 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.

    Measured: Week 32

  4. Time From Randomization to Relapse of Major Depressive Disorder During the Entire 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. 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 IQR was 25th percentile to 75th percentile.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2015 (estimated)
  2. Study start10 Feb 2015
  3. Primary completion1 Mar 2019
  4. Study completion25 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02371980
Sponsor's protocol ID
LuAA21004_402
Other IDs
U1111-1161-4956
Status last verified
Dec 2020
First submitted
20 Feb 2015
Last updated
6 Jan 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 35131363

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vortioxetine in people with Major Depressive Disorder, run by Takeda at 79 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 79 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time From Randomization to Relapse of Major Depressive Disorder During the First 28 Weeks of the 32-Week Double-Blind Treatment Period (time frame: 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02371980, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021.

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