Randomised Placebo-controlled Duloxetine-referenced Study of Efficacy and Safety of 5 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Elderly Patients

Lundbeck

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: Vortioxetine (Lu AA21004); Drug: Duloxetine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00811252

12541A

2008-002901-38 (EudraCT Number)

Details and patient eligibility

About

To assess the efficacy of Vortioxetine (5 mg daily) versus placebo in the acute treatment of depression by means of the change from baseline in the 24-item Hamilton Depression Scale (HAM-D24) total score after 8 weeks of double-blind treatment in elderly patients.

Enrollment: 453 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Clinical Diagnosis of recurrent Major Depressive Episode (MDE) according the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria with:

• Reported duration of the current episode of at least 4 weeks
• MADRS total score >=26
• At least one previous MDE before the age of 60 years

Exclusion criteria

• Mini Mental State Exam (MMSE) <24
• Any current anxiety 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's disease, Parkinson disease, multiple sclerosis, Huntington disease, etc)
• Any Axis II disorder that might compromise the study
• Significant risk of suicide according to the investigator's opinion, or has a score >=5 on item 10 of the MADRS or has made a suicide attempt in the previous 6 months

Other inclusion and exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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453 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Vortioxetine 5 mg

Experimental group

Treatment:

Drug: Vortioxetine (Lu AA21004)

Duloxetine 60 mg

Other group

Description:

Active reference

Treatment:

Drug: Duloxetine