Efficacy and Safety of Vortioxetine (Lu AA21004) in the Treatment of Patients 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 vortioxetine, once daily (QD), in adults with major depressive disorder.

Key facts

Study ID

NCT00672620

Run by

Takeda

People needed

611

Starts

2008-04-01

Expected to finish

2008-12-01

Last updated by the study team

2013-12-18

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 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 major depressive episode is at least 3 months.

You may not qualify if…

• Has 1 or more the following:
• Any current psychiatric disorder other than major depressive disorder as defined in the DSM-IV-TR.
• 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.
• Has a significant risk of suicide according to the investigator's opinion or has a score ≥5 on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale (MADRS) or has made a suicide attempt in the previous 6 months.
• The current depressive symptoms of the patient 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 — Beverly Hills, California, United States
• Study site — Irvine, California, United States
• Study site — Santa Ana, California, United States
• Study site — Torrance, California, United States
• Study site — Upland, California, United States
• Study site — Bradenton, Florida, United States
• Study site — Coral Springs, Florida, United States
• Study site — Fort Walton Beach, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Maitland, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — South Miami, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Smyrna, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Libertyville, Illinois, United States
• Study site — Oak Brook, Illinois, United States
• Study site — Prairie Village, Kansas, United States
• Study site — Owensboro, Kentucky, United States
• Study site — Baltimore, Maryland, United States
• Study site — Pittsfield, Massachusetts, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Flowood, Mississippi, United States

Full record on ClinicalTrials.gov

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