Overview

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

Status:
Completed
Trial end date:
2010-03-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
H. Lundbeck A/S
Treatments:
Duloxetine Hydrochloride
Vortioxetine
Criteria
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.