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

Completed · Phase 3 · Has a placebo group

Conditions studied: Depressive Disorder, Major

In brief

The purpose of this study is to evaluate the efficacy of vortioxetine, once daily (QD), compared with placebo in adults with major depressive disorder.

Key facts

Study ID

NCT01163266

Run by

Takeda

People needed

462

Starts

2010-07-01

Expected to finish

2012-01-01

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 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Anaheim, California, United States
• Study site — Cerritos, California, United States
• Study site — Costa Mesa, California, United States
• Study site — Encino, California, United States
• Study site — Garden Grove, California, United States
• Study site — Irvine, California, United States
• Study site — Pico Rivera, California, United States
• Study site — Riverside, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Norwich, Connecticut, United States
• Study site — Maitland, Florida, United States
• Study site — North Miami, Florida, United States
• Study site — Orange City, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Smyrna, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Joliet, Illinois, United States
• Study site — Skokie, Illinois, United States
• Study site — Wichita, Kansas, United States
• Study site — Lake Charles, Louisiana, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Saint Charles, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Willingboro, New Jersey, United States

Full record on ClinicalTrials.gov

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