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

NCT01179516 | Completed Phase 3 Results

• 3 other identifiers: LuAA21004_317U1111-1116-3223SU-06032011-7846
• Study Type: interventional
• Target: 469
• Locations: 1 country
• Sites: 61

Brief 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.

Conditions

Depressive Disorder, Major

Keywords

Major Depressive Disorder; Depression; Drug Therapy

Outcome Measures

Primary Outcomes (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.

  Baseline and Week 8

Secondary Outcomes (5)

• Percentage of Participants With a MADRS Response at Week 8

  Baseline and Week 8

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

  Week 8

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

  Baseline and Week 8

• Percentage of Participants in MADRS Remission at Week 8

  Week 8

• Change From Baseline in Sheehan Disability Scale (SDS) Total Score

  Baseline and Week 8

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.

Drug: Placebo

Vortioxetine 10 mg

EXPERIMENTAL

Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.

Drug: Vortioxetine

Vortioxetine 15 mg

EXPERIMENTAL

Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.

Drug: Vortioxetine

Interventions

Vortioxetine DRUG

Encapsulated vortioxetine immediate release tablets

Also known as: Lu AA21004, Brintellix®

Vortioxetine 10 mg; Vortioxetine 15 mg

Placebo DRUG

Vortioxetine placebo-matching capsules

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (61)

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Little Rock, Arkansas, United States

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Carson, California, United States

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Cerritos, California, United States

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El Centro, California, United States

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Fresno, California, United States

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Glendale, California, United States

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Los Angeles, California, United States

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Oakland, California, United States

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Oceanside, California, United States

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San Diego, California, United States

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Santa Ana, California, United States

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Sherman Oaks, California, United States

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Stanford, California, United States

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Upland, California, United States

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Denver, Colorado, United States

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Hartford, Connecticut, United States

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Hockessin, Delaware, United States

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Fort Walton Beach, Florida, United States

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Kissimmee, Florida, United States

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Miami, Florida, United States

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Pompano Beach, Florida, United States

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Atlanta, Georgia, United States

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Hoffman Estates, Illinois, United States

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Naperville, Illinois, United States

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Oak Brook, Illinois, United States

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Indianapolis, Indiana, United States

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Lafayette, Indiana, United States

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Newburgh, Indiana, United States

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Prarie Ridge, Kansas, United States

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Wichita, Kansas, United States

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Baltimore, Maryland, United States

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Fall River, Massachusetts, United States

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Watertown, Massachusetts, United States

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Clinton Township, Michigan, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Nashua, New Hampshire, United States

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Albuquerque, New Mexico, United States

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Staten Island, New York, United States

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Avon Lake, Ohio, United States

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Beachwood, Ohio, United States

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Canton, Ohio, United States

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Garfield Heights, Ohio, United States

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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Salem, Oregon, United States

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Allentown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Lincoln, Rhode Island, United States

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Columbia, South Carolina, United States

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Franklin, Tennessee, United States

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Dallas, Texas, United States

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DeSoto, Texas, United States

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Houston, Texas, United States

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Lake Jackson, Texas, United States

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San Antonio, Texas, United States

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The Woodlands, Texas, United States

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Salt Lake City, Utah, United States

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Roanoke, Virginia, United States

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Milwaukee, Wisconsin, United States

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Related Publications (1)

• 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.

  PMID: 26035186 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Vortioxetine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Director, Clinical Science
• Organization: Takeda

clinicaltrialregistry@tpna.com

800-778-2860

Study Officials

• Medical Director, Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: August 9, 2010
• First Posted: August 11, 2010
• Study Start: August 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2012
• Last Updated: December 18, 2013
• Results First Posted: December 18, 2013

Record last verified: 2013-10

Locations

US (61)