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

NCT00811252 | Completed Phase 3 Results

• 2 other identifiers: 12541A2008-002901-38
• Study Type: interventional
• Target: 453
• Locations: 0 countries
• Sites: N/A

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

Keywords

Depression; Elderly; Acute treatment

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline and Week 8

Secondary Outcomes (12)

• 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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Vortioxetine 5 mg

EXPERIMENTAL

Drug: Vortioxetine (Lu AA21004)

Duloxetine 60 mg

OTHER

Active reference

Drug: Duloxetine

Interventions

Placebo DRUG

capsules; daily; orally

Placebo

Vortioxetine (Lu AA21004) DRUG

encapsulated tablets; daily; orally

Also known as: Brintellix

Vortioxetine 5 mg

Duloxetine DRUG

encapsulated tablets; daily; orally

Also known as: Cymbalta®

Duloxetine 60 mg

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Related Publications (1)

• 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.

  PMID: 22572889 RESULT

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Vortioxetine; Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiophenes; Sulfur Compounds; Organic Chemicals

Results Point of Contact

• Title: H. Lundbeck A/S
• Organization: H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com

+45 3630 1311

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2008
• First Posted: December 18, 2008
• Study Start: January 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: March 1, 2010
• Last Updated: January 29, 2014
• Results First Posted: December 18, 2013

Record last verified: 2013-12