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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00811252
• Other study ID #: 12541A
• Secondary ID: 2008-002901-38
• Status: Completed
• Phase: Phase 3
• First received: December 17, 2008
• Last updated: December 23, 2013
• Start date: January 2009
• Est. completion date: March 2010

Study information

• Verified date: December 2013
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesSweden: Medical Products AgencyUkraine: Ministry of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 453
• Est. completion date: March 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Placebo
capsules; daily; orally
• Vortioxetine (Lu AA21004)
encapsulated tablets; daily; orally
• Duloxetine
encapsulated tablets; daily; orally

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change From Baseline in HAM-D-24 Total Score After 6 Weeks of Treatment		Baseline and Week 6	No
Secondary	Change From Baseline in HAM-D-24 Total Score After 4 Weeks of Treatment		Baseline and Week 4	No
Secondary	Change From Baseline in HAM-D-24 Total Score After 2 Weeks of Treatment		Baseline and Week 2	No
Secondary	Change From Baseline in HAM-D-24 Total Score After 1 Week of Treatment		Baseline and Week 1	No
Secondary	Change From Baseline in MADRS Total Score After 8 Weeks of Treatment	The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.	Baseline and Week 8	No
Secondary	Change From Baseline in HAM-A Total Score After 8 Weeks of Treatment	The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe.	Baseline and Week 8	No
Secondary	Change From Baseline in CGI-S Score After 8 Weeks of Treatment	The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.	Baseline and Week 8	No
Secondary	Change in Clinical Status Using CGI-I Score at Week 8	The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment.	Week 8	No
Secondary	Change From Baseline in GDS Total Score After 8 Weeks of Treatment	The Geriatric Depression Scale (GDS) is a patient self-rating scale designed for the screening of depression in the elderly. It has also been validated as a measure of depression severity. The original version consists of 30 questions with a yes/no answer. In this study, the short 15-item version was used. The total score ranges from 0 to 15, with 15 representing maximum severity.	Baseline and Week 8	No
Secondary	Proportion of Responders at Week 8 (Response Defined as a >=50% Reduction in the HAM-D-24 Total Score)		Week 8	No
Secondary	Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10)		Week 8	No
Secondary	Risk of Suicidality Using C-SSRS Scores	The Columbia-Suicide Severity Rating Scale (C-SSRS) was developed by researchers at Columbia University as a tool to systematically assess suicidal ideation and behaviour in patients during participation in a clinical study. The C-SSRS is composed of questions that address suicidal behaviour and questions that address suicidal ideation, with sub-questions that assess severity. The tool was administered via an interview with the patient.	Up to 8 weeks	Yes