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Depressive Disorder, MajorPhase 3NCT01179516

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

A Phase 3 study testing Vortioxetine in people with Depressive Disorder, Major, run by Takeda at 61 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
469 participants
Where
61 sitesUnited States
Study dates
Aug 2010to Jun 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

  • 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.
  • 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 received any investigational compound <30 days before Screening or 5 half-lives prior to Screening.
  • Has received Lu AA21004 in a previous clinical study.
  • Has 1 or more the following:
  • Any current psychiatric disorder other than MDD as defined in the DSM-IV-TR .
  • 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.
  • 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.
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  • Presence or history of a clinically significant neurological disorder (including epilepsy).
  • Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
  • 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:
  • A serum creatinine value >1.5 times the upper limits of normal (× ULN).
  • A total serum total bilirubin value >1.5 × ULN.
  • 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.

Trial locations and contacts

61 sites in 1 country.

61 sites in 1 country

United States61 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Allentown, Pennsylvania

  • Study site

    Atlanta, Georgia

  • Study site

    Avon Lake, Ohio

  • Study site

    Baltimore, Maryland

  • Study site

    Beachwood, Ohio

  • Study site

    Canton, Ohio

  • Study site

    Carson, California

  • Study site

    Cerritos, California

  • Study site

    Clinton Township, Michigan

  • Study site

    Columbia, South Carolina

  • Study site

    Dallas, Texas

  • Study site

    Denver, Colorado

  • Study site

    DeSoto, Texas

  • Study site

    El Centro, California

  • Study site

    Fall River, Massachusetts

  • Study site

    Fort Walton Beach, Florida

  • Study site

    Franklin, Tennessee

  • Study site

    Fresno, California

  • Study site

    Garfield Heights, Ohio

  • Study site

    Glendale, California

  • Study site

    Hartford, Connecticut

  • Study site

    Hockessin, Delaware

  • Study site

    Hoffman Estates, Illinois

  • Study site

    Houston, Texas

  • Study site

    Indianapolis, Indiana

  • Study site

    Kissimmee, Florida

  • Study site

    Lafayette, Indiana

  • Study site

    Lake Jackson, Texas

  • Study site

    Las Vegas, Nevada

  • Study site

    Lincoln, Rhode Island

  • Study site

    Little Rock, Arkansas

  • Study site

    Los Angeles, California

  • Study site

    Miami, Florida

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Naperville, Illinois

  • Study site

    Nashua, New Hampshire

  • Study site

    Newburgh, Indiana

  • Study site

    Oak Brook, Illinois

  • Study site

    Oakland, California

  • Study site

    Oceanside, California

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Pompano Beach, Florida

  • Study site

    Prarie Ridge, Kansas

  • Study site

    Roanoke, Virginia

  • Study site

    Salem, Oregon

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    Santa Ana, California

  • Study site

    Sherman Oaks, California

  • Study site

    St Louis, Missouri

  • Study site

    Stanford, California

  • Study site

    Staten Island, New York

  • Study site

    The Woodlands, Texas

  • Study site

    Toledo, Ohio

  • Study site

    Upland, California

  • Study site

    Watertown, Massachusetts

  • Study site

    Wichita, Kansas

Other trials in United States

About this study

Official title: A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of 2 Doses (10 and 15 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 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.

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

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

  • PlaceboDrug

    Vortioxetine placebo-matching capsules

Study groups in NCT01179516
Study groupRoleWhat they receive
PlaceboPlacebo comparatorVortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Receives: Drug: Placebo
Vortioxetine 10 mgExperimentalVortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
Receives: Drug: Vortioxetine
Vortioxetine 15 mgExperimentalVortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
Receives: Drug: Vortioxetine

What is being measured

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

  1. Change From Baseline in 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 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

    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 posted11 Aug 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionMay 2012
  4. Study completionJun 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
469 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01179516
Sponsor's protocol ID
LuAA21004_317
Other IDs
U1111-1116-3223, SU-06032011-7846
Status last verified
Oct 2013
First submitted
9 Aug 2010
Last updated
18 Dec 2013
Data monitoring committee
No

Publications

  • 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.

    PubMed 26035186

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vortioxetine in people with Depressive Disorder, Major, run by Takeda at 61 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 22 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 61 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 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 NCT01179516, 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 18 Dec 2013.

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