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

NCT ID: NCT00811252

Last Updated: 2014-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 453 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-03-31

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

capsules; daily; orally

Vortioxetine 5 mg

Group Type: EXPERIMENTAL

Vortioxetine (Lu AA21004)

Intervention Type: DRUG

encapsulated tablets; daily; orally

Duloxetine 60 mg

Active reference

Group Type: OTHER

Duloxetine

Intervention Type: DRUG

encapsulated tablets; daily; orally

Interventions

Placebo

capsules; daily; orally

Intervention Type: DRUG

Vortioxetine (Lu AA21004)

encapsulated tablets; daily; orally

Intervention Type: DRUG

Duloxetine

encapsulated tablets; daily; orally

Intervention Type: DRUG

Other Intervention Names

Brintellix; Cymbalta®

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@lundbeck.com

References

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.

Reference Type: RESULT

PMID: 22572889 (View on PubMed)

Other Identifiers

2008-002901-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

12541A

Identifier Type: -

Identifier Source: org_study_id