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

Completed · Phase 3 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

The purpose of this study is to determine the efficacy and safety of once daily vortioxetine (Lu AA21004) in adults with major depressive disorder.

Key facts

Study ID

NCT00672958

Run by

Takeda

People needed

600

Starts

2008-04-01

Expected to finish

2008-11-01

Last updated by the study team

2013-12-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Suffers from a major depressive episode (MDE) as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, 4th 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 total score greater than or equal to 30.
• Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.

You may not qualify if…

• Has received any investigational compound less than 30 days before Screening or 5 half-lives prior to Screening, whichever is longer.
• Has received Lu AA21004 in a previous clinical study.
• Has 1 or more the following:
• Any current psychiatric disorder other than major depressive disorder as defined in the DSM-IV-TR (as assessed by the Mini International Neuropsychiatric Interview)
• 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.
• Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR.
• 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.
• Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
• Narcotic analgesics
• Nonsteroidal anti-inflammatory drugs
• Rifampin
• Macrolide antibiotics
• Hormones (only thyroid hormone replacement, contraceptives [oral, patch], estrogen and progesterone replacement therapy are allowed in chronic use)
• Hypoglycemic agents (chronic use is allowed)
• Insulin (chronic use is allowed)
• Systemic steroids
• Quinidine
• Antineoplastics
• Antiobesity agents
• 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.
• 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 received electroconvulsive therapy within 6 months prior to Screening.
• Is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Cerritos, California, United States
• Study site — Encino, California, United States
• Study site — Fresno, California, United States
• Study site — San Diego, California, United States
• Study site — Farmington, Connecticut, United States
• Study site — Jacksonville, Florida, United States
• Study site — North Miami, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Hoffman Estate, Illinois, United States
• Study site — Lafayette, Indiana, United States
• Study site — Valparaiso, Indiana, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Saint Paul, Minnesota, United States
• Study site — Florissant, Missouri, United States
• Study site — Saint Charles, Missouri, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Rochester, New York, United States
• Study site — Dayton, Ohio, United States
• Study site — Toledo, Ohio, United States
• Study site — Tulsa, Oklahoma, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Lincoln, Rhode Island, United States
• Study site — North Charleston, South Carolina, United States
• Study site — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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