Randomised, Double-blind, Parallel-group, Placebo-controlled, Duloxetine-referenced, Fixed Dose Study Comparing the Efficacy and Safety of [Vortioxetine] Lu AA21004 in Acute Treatment of Major Depressive Disorder in Elderly Patients

H. Lundbeck A/S0 sites453 target enrollmentJanuary 2009

ConditionsMajor Depressive Disorder

InterventionsPlacebo Vortioxetine (Lu AA21004)Duloxetine

DrugsPlacebo Vortioxetine (Lu AA21004)Duloxetine

Overview

Phase: Phase 3
Intervention: Placebo
Conditions: Major Depressive Disorder
Sponsor: H. Lundbeck A/S
Enrollment: 453
Primary Endpoint: Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 2009

End Date

March 2010

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

H. Lundbeck A/S

Responsible Party

Sponsor

Eligibility 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.

Arms & Interventions

Placebo

Intervention: Placebo

Vortioxetine 5 mg

Intervention: Vortioxetine (Lu AA21004)

Duloxetine 60 mg

Active reference

Intervention: Duloxetine

Outcomes

Primary Outcomes

Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment

Time Frame: Baseline and Week 8

The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.

Secondary Outcomes

Change From Baseline in HAM-D-24 Total Score After 6 Weeks of Treatment(Baseline and Week 6)
Change From Baseline in HAM-D-24 Total Score After 4 Weeks of Treatment(Baseline and Week 4)
Change From Baseline in HAM-D-24 Total Score After 2 Weeks of Treatment(Baseline and Week 2)
Change From Baseline in HAM-D-24 Total Score After 1 Week of Treatment(Baseline and Week 1)
Change From Baseline in MADRS Total Score After 8 Weeks of Treatment(Baseline and Week 8)
Change From Baseline in HAM-A Total Score After 8 Weeks of Treatment(Baseline and Week 8)
Change From Baseline in CGI-S Score After 8 Weeks of Treatment(Baseline and Week 8)
Change in Clinical Status Using CGI-I Score at Week 8(Week 8)
Change From Baseline in GDS Total Score After 8 Weeks of Treatment(Baseline and Week 8)
Proportion of Responders at Week 8 (Response Defined as a >=50% Reduction in the HAM-D-24 Total Score)(Week 8)
Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10)(Week 8)
Risk of Suicidality Using C-SSRS Scores(Up to 8 weeks)