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

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effectiveness and safety of vortioxetine, once daily (QD), in patients with Major Depressive Disorder.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Collaborator: H. Lundbeck A/S
• Treatments: Vortioxetine

Criteria

Inclusion Criteria:

• Has a primary diagnosis of major depressive episode according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.

• The reported duration of the current major depressive episode is at least 3 months.

• Has a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥26.

• A male or a female of childbearing potential who is sexually active agrees to use adequate contraception from Screening throughout the duration of the study and for 1 month after the last dose of study medication.

Exclusion Criteria:

• 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. (must have negative urine drug screen prior to Baseline).

• Presence or history of a clinically significant neurological disorder (including epilepsy).

• Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).

• 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, or has made a suicide attempt in the previous 6 months.

• Currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.

• Has a clinically significant unstable illness.

• Has previously failed to respond to adequate treatment with selective serotonin reuptake inhibitors and/or serotonin-norepinephrine reuptake inhibitors.

• Has received electroconvulsive therapy within 6 months prior to Screening.

• Has an alanine aminotransferase, aspartate aminotransferase, or total bilirubin level > 1.5 times the upper limit of normal.

• Has a serum creatinine of > 1.5 × upper limit of normal.

• Has a previous history of cancer that had been in remission for less than 5 years.

• Has thyroid stimulating hormone value outside the normal range.

• Has an abnormal electrocardiogram.