Clinical trial NCT00811252: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Depression
Elderly
Acute treatment
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2008-12-18
Enrollment: 453
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment
timeFrame: Baseline and Week 8
Secondary outcomes:
measure: Change From Baseline in HAM-D-24 Total Score After 6 Weeks of Treatment
timeFrame: Baseline and Week 6
measure: Change From Baseline in HAM-D-24 Total Score After 4 Weeks of Treatment
timeFrame: Baseline and Week 4
measure: Change From Baseline in HAM-D-24 Total Score After 2 Weeks of Treatment
timeFrame: Baseline and Week 2
measure: Change From Baseline in HAM-D-24 Total Score After 1 Week of Treatment
timeFrame: Baseline and Week 1
measure: Change From Baseline in MADRS Total Score After 8 Weeks of Treatment
timeFrame: Baseline and Week 8
measure: Change From Baseline in HAM-A Total Score After 8 Weeks of Treatment
timeFrame: Baseline and Week 8
measure: Change From Baseline in CGI-S Score After 8 Weeks of Treatment
timeFrame: Baseline and Week 8
measure: Change in Clinical Status Using CGI-I Score at Week 8
timeFrame: Week 8
measure: Change From Baseline in GDS Total Score After 8 Weeks of Treatment
timeFrame: Baseline and Week 8
measure: Proportion of Responders at Week 8 (Response Defined as a >=50% Reduction in the HAM-D-24 Total Score)
timeFrame: Week 8
measure: Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10)
timeFrame: Week 8
measure: Risk of Suicidality Using C-SSRS Scores
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
citation: Katona C, Hansen T, Olsen CK. A randomized, double-blind, placebo-controlled, duloxetine-referenced, fixed-dose study comparing the efficacy and safety of Lu AA21004 in elderly patients with major depressive disorder. Int Clin Psychopharmacol. 2012 Jul;27(4):215-23. doi: 10.1097/YIC.0b013e3283542457.