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Depressive Disorder, MajorPhase 3NCT01153009

Safety and Efficacy of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder

A Phase 3 study testing Vortioxetine and Duloxetine in people with Depressive Disorder, Major, run by Takeda at 56 sites in United States.

Completed

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

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of vortioxetine, once daily (QD), compared with placebo in adults with major depressive disorder. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Depressive Disorder, Major
What is being tested?
Vortioxetine and Duloxetine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
614 participants
Where
56 sitesUnited States
Study dates
Jun 2010to Mar 2012
Phase
Phase 3
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

  • Man or a woman who suffers from a major depressive episode (MDE) recurrent as the primary diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria (classification code 296.3x) as confirmed by the Structured Clinical Interview for DSM Disorders (SCID).
  • 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.

Who cannot join

  • Has previously participated in a Lu AA21004 clinical study.
  • Has 1 or more the following:
  • Any current psychiatric disorder other than major depressive disorder (MDD) as defined in the DSM-IV-TR (as assessed by the SCID).
  • 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.
  • Diagnosis of any substance abuse or dependence (except nicotine and caffeine) as defined in the DSM-IV-TR that has not been in sustained full remission for at least 2 years prior to screening (subject must also have negative urine drug screen prior to Baseline).
  • Presence or history of a clinically significant neurological disorder (including epilepsy).
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  • Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
  • Any Axis II disorder that might compromise the study.
  • The current depressive symptoms are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each. Has 1 or more laboratory values 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.
  • Has a thyroid stimulating hormone value outside the normal range at the Screening Visit that is deemed clinically significant by the investigator.
  • Has clinically significant abnormal vital signs as determined by the investigator.
  • Has an abnormal electrocardiogram as determined by the central reader and confirmed as clinically significant by the investigator.
  • Has an alanine aminotransferase, aspartate aminotransferase or total bilirubin level greater than 1.5 times the upper limits of normal.
  • Has a previous history of cancer that had been in remission for less than 5 years prior to the first dose of study medication. This criterion does not include those patients with basal cell or Stage I squamous cell carcinoma of the skin.
  • Has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability, or efficacy.
  • Has a known history of or currently has increased intraocular pressure or is at risk of acute narrow-angle glaucoma.
  • Has a clinically significant unstable illness, for example, hepatic impairment or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, infectious, skin and subcutaneous tissue disorders, or metabolic disturbance. The following are also considered unstable due to the potential impact on assessment of MDD response: pain disorder, chronic fatigue syndrome, fibromyalgia, and obstructive sleep apnea.
  • Has a significant risk of suicide according to the investigator's opinion or has a score greater than or equal to 5 on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale or has made a suicide attempt in the previous 6 months.

Trial locations and contacts

56 sites in 1 country.

56 sites in 1 country

United States56 sites

  • Study site

    Allentown, Pennsylvania

  • Study site

    Atlanta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Beverly Hills, California

  • Study site

    Boca Raton, Florida

  • Study site

    Boston, Massachusetts

  • Study site

    Cedarhurst, New York

  • Study site

    Chicago, Illinois

  • Study site

    Chino, California

  • Study site

    Cincinnati, Ohio

  • Study site

    Colorado Springs, Colorado

  • Study site

    Dallas, Texas

  • Study site

    Flowood, Mississippi

  • Study site

    Fort Myers, Florida

  • Study site

    Fresh Meadows, New York

  • Study site

    Gainesville, Florida

  • Study site

    Garden Grove, California

  • Study site

    Houston, Texas

  • Study site

    Irvine, California

  • Study site

    Irving, Texas

  • Study site

    Jacksonville, Florida

  • Study site

    Lauderhill, Florida

  • Study site

    Libertyville, Illinois

  • Study site

    Los Alamitos, California

  • Study site

    Marietta, Georgia

  • Study site

    Media, Pennsylvania

  • Study site

    Memphis, Tennessee

  • Study site

    Middleton, Wisconsin

  • Study site

    Nashville, Tennessee

  • Study site

    New York, New York

  • Study site

    North Charleston, South Carolina

  • Study site

    Norwalk, Connecticut

  • Study site

    Oakbrook Ter, Illinois

  • Study site

    Oceanside, California

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Orem, Utah

  • Study site

    Orlando, Florida

  • Study site

    Pasadena, California

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Pico Rivera, California

  • Study site

    Portland, Oregon

  • Study site

    Richmond, Virginia

  • Study site

    Rochester, New York

  • Study site

    Rochester Hills, Michigan

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    Shreveport, Louisiana

  • Study site

    Staten Island, New York

  • Study site

    Tampa, Florida

  • Study site

    Toledo, Ohio

  • Study site

    Toms River, New Jersey

  • Study site

    Valparaiso, Indiana

  • Study site

    Waukesha, Wisconsin

  • Study site

    West Palm Beach, Florida

  • Study site

    Weymouth, Massachusetts

  • Study site

    Woodstock, Vermont

Other trials in United States

About this study

Official title: A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Duloxetine-Referenced, Fixed-Dose Study Comparing the Efficacy and Safety of 2 Doses (15 and 20 mg) of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder

The purpose of this study is to evaluate the efficacy, safety and tolerability of vortioxetine, once daily (QD), compared with placebo in adults with major depressive disorder.

Read the detailed description

The drug that was tested in this study is called Vortioxetine. Vortioxetine is being tested to treat depression in adults who have major depressive disorder (MDD). This study looked at MDD relief in people who took varying dosages of vortioxetine.

The study enrolled 614 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):

  • Vortioxetine 15 mg
  • Vortioxetine 20 mg
  • Duloxetine 60 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 13 weeks. Participants made 9 visits to the clinic, and were contacted by telephone 4 weeks after the last dose of study drug for a follow-up assessment.

Being tested
Vortioxetine, Duloxetine, Placebo
Keywords
Major Depressive Disorder, Depression, Melancholia, Drug Therapy
Medical subject headings
Depressive Disorder, Major, Depression, Depressive Disorder

What participants receive

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

  • VortioxetineDrug

    Also called Lu AA21004, Brintellix®

    Encapsulated vortioxetine immediate release tablets

  • DuloxetineDrug

    Also called Cymbalta®

    Overencapsulated duloxetine delayed-release capsules

  • PlaceboDrug

    Placebo-matching capsules

Study groups in NCT01153009
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo-matching capsules, orally, once daily for up to 9 weeks.
Receives: Drug: Placebo
Vortioxetine 15 mgExperimentalVortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
Receives: Drug: Vortioxetine
Vortioxetine 20 mgExperimentalVortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
Receives: Drug: Vortioxetine
Duloxetine 60 mgActive comparatorDuloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
Receives: Drug: Duloxetine

What is being measured

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

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

    The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least squares (LS) means are from a mixed model for repeated measurements (MMRM) analysis of covariance (ANCOVA) with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.

    Measured: Baseline and Week 8

Secondary outcomes (5)

  1. Percentage of Participants With a MADRS Response at Week 8

    Response is defined as a participant with a ≥50% decrease in Montgomery Åsberg Depression Rating Scale (MADRS) total score from Baseline. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.

    Measured: Baseline and Week 8

  2. Mean Clinical Global Impression Scale - Improvement (CGI-I) Score at Week 8

    The Clinical Global Impression-Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline Clinical Global Impression Scale-Severity of Illness (CGI-S) score-by-week as fixed effects.

    Measured: Week 8

  3. Change From Baseline in MADRS Total Score at Week 8 in Participants With Baseline Hamilton Anxiety Scale (HAM-A) Total Score ≥20

    The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. LS means are from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.

    HAM-A is a 14 item rating scale to quantify anxiety severity rated on a 5-point scale from 0 (not present) to 4 (severe) with a total score range from 0 to 56, where lower scores indicate mild severity.

    Measured: Baseline and Week 8

  4. Percentage of Participants in MADRS Remission at Week 8

    Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.

    Measured: Week 8

  5. Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8

    The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline SDS total score-by-week as fixed effects.

    Measured: Baseline and Week 8

Timeline

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

  1. First posted29 Jun 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionMar 2012
  4. Study completionMar 2012

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
614 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01153009
Sponsor's protocol ID
LuAA21004_315
Other IDs
U1111-1114-8191
Status last verified
Oct 2013
First submitted
28 Jun 2010
Last updated
18 Dec 2013
Data monitoring committee
No

Publications

  • Adair M, Christensen MC, Florea I, Loft H, Fagiolini A. Vortioxetine in patients with major depressive disorder and high levels of anxiety symptoms: An updated analysis of efficacy and tolerability. J Affect Disord. 2023 May 1;328:345-354. doi: 10.1016/j.jad.2023.01.074. Epub 2023 Jan 26.

    PubMed 36708956

  • Christensen MC, Florea I, Loft H, McIntyre RS. Efficacy of vortioxetine in patients with major depressive disorder reporting childhood or recent trauma. J Affect Disord. 2020 Feb 15;263:258-266. doi: 10.1016/j.jad.2019.11.074. Epub 2019 Nov 13.

    PubMed 31818787

  • Mahableshwarkar AR, Jacobsen PL, Chen Y, Serenko M, Trivedi MH. A randomized, double-blind, duloxetine-referenced study comparing efficacy and tolerability of 2 fixed doses of vortioxetine in the acute treatment of adults with MDD. Psychopharmacology (Berl). 2015 Jun;232(12):2061-70. doi: 10.1007/s00213-014-3839-0. Epub 2015 Jan 11.

    PubMed 25575488

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vortioxetine and Duloxetine in people with Depressive Disorder, Major, run by Takeda at 56 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 4 inclusion and 18 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 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 18 Dec 2013). 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?

Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score (time frame: Baseline and Week 8). 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 NCT01153009, which also lists 3 linked publications.

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 18 Dec 2013.

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