Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01163266
Recruitment Status : Completed
First Posted : July 15, 2010
Results First Posted : December 18, 2013
Last Update Posted : December 18, 2013
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to evaluate the efficacy of vortioxetine, once daily (QD), compared with placebo in adults with major depressive disorder.

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: Vortioxetine Drug: Placebo Phase 3

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 462 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 20 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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 462 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 20 mg) of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder
Study Start Date : July 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo-matching capsules, orally, once daily for up to 8 weeks.
 Drug: Placebo
Vortioxetine placebo-matching capsules
Experimental: Vortioxetine 10 mg
Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
 Drug: Vortioxetine
Encapsulated vortioxetine immediate release tablets
Other Names:
  • Lu AA21004
  • Brintellix®
Experimental: Vortioxetine 20 mg
Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
 Drug: Vortioxetine
Encapsulated vortioxetine immediate release tablets
Other Names:
  • Lu AA21004
  • Brintellix®


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Baseline and Week 8 ]
    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.


Secondary Outcome Measures :
  1. Percentage of Participants With a MADRS Response at Week 8 [ Time Frame: Baseline and 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.

  2. Mean Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 8 [ Time Frame: 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 Scale (CGI-S) score-by-week as fixed effects.

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

    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.

    The 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.


  4. Percentage of Participants in MADRS Remission at Week 8 [ Time Frame: 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.

  5. Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8 [ Time Frame: Baseline and 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Suffers from a major depressive episode recurrent as the primary diagnosis according to the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.
  • 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.

Exclusion Criteria:

  • Has previously participated in a Lu AA21004 clinical study.

  • Has 1 or more the following:

    • Any current psychiatric disorder other than Major Depressive Disorder as defined in the DSM-IV
    • Current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder defined in the DSM-IV-TR.
    • Diagnosis of alcohol or other substance disorder (except nicotine and caffeine) as defined in the DSM-IV-TR that has not been in sustained full remission for at least years prior to screening (participant must also have negative urine drug screen prior to Baseline).
    • Presence or history of a clinically significant neurological disorder (including epilepsy)
    • Neurodegenerative disorder.
    • Any Axis II disorder that might compromise the study.
  • 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.
  • 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.
  • 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. For the purposes of this protocol the following conditions are 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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01163266


Locations
Layout table for location information
United States, California
Anaheim, California, United States
Cerritos, California, United States
Costa Mesa, California, United States
Encino, California, United States
Garden Grove, California, United States
Irvine, California, United States
Pico Rivera, California, United States
Riverside, California, United States
United States, Colorado
Colorado Springs, Colorado, United States
United States, Connecticut
Norwich, Connecticut, United States
United States, Florida
Maitland, Florida, United States
North Miami, Florida, United States
Orange City, Florida, United States
Orlando, Florida, United States
St. Petersburg, Florida, United States
United States, Georgia
Smyrna, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
Joliet, Illinois, United States
Skokie, Illinois, United States
United States, Kansas
Wichita, Kansas, United States
United States, Louisiana
Lake Charles, Louisiana, United States
United States, Massachusetts
Worcester, Massachusetts, United States
United States, Missouri
St. Charles, Missouri, United States
St. Louis, Missouri, United States
United States, New Jersey
Willingboro, New Jersey, United States
United States, New York
Buffalo, New York, United States
New York, New York, United States
Rochester, New York, United States
United States, Ohio
Cinti, Ohio, United States
Dayton, Ohio, United States
Middleburg Heights, Ohio, United States
United States, Oregon
Portland, Oregon, United States
United States, Pennsylvania
Norristown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
United States, South Carolina
Charleston, South Carolina, United States
United States, Texas
Irving, Texas, United States
United States, Virginia
Richmond, Virginia, United States
United States, Washington
Seattle, Washington, United States
United States, Wisconsin
Brown Deer, Wisconsin, United States
Sponsors and Collaborators
Takeda
Investigators
Layout table for investigator information
Study Director: Medical Director, Clinical Science Takeda
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01163266    
Other Study ID Numbers: LuAA21004_316
U1111-1115-8770 ( Registry Identifier: WHO )
First Posted: July 15, 2010    Key Record Dates
Results First Posted: December 18, 2013
Last Update Posted: December 18, 2013
Last Verified: October 2013
Keywords provided by Takeda:
Major Depressive Disorder
Depression
Melancholia
Drug Therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Vortioxetine
Antidepressive Agents
Psychotropic Drugs
Anti-Anxiety Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin 5-HT3 Receptor Antagonists
Serotonin Antagonists