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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00811252
First received: December 17, 2008
Last updated: December 23, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Drug: Placebo
Drug: Vortioxetine (Lu AA21004)
Drug: Duloxetine
Phase 3

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

Resource links provided by NLM:


Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Change From Baseline in HAM-D-24 Total Score After 6 Weeks of Treatment [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
  • Change From Baseline in HAM-D-24 Total Score After 4 Weeks of Treatment [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
  • Change From Baseline in HAM-D-24 Total Score After 2 Weeks of Treatment [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
  • Change From Baseline in HAM-D-24 Total Score After 1 Week of Treatment [ Time Frame: Baseline and Week 1 ] [ Designated as safety issue: No ]
  • Change From Baseline in MADRS Total Score After 8 Weeks of Treatment [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in HAM-A Total Score After 8 Weeks of Treatment [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in CGI-S Score After 8 Weeks of Treatment [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    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.

  • Change in Clinical Status Using CGI-I Score at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in GDS Total Score After 8 Weeks of Treatment [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    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.

  • Proportion of Responders at Week 8 (Response Defined as a >=50% Reduction in the HAM-D-24 Total Score) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Risk of Suicidality Using C-SSRS Scores [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 453
Study Start Date: January 2009
Study Completion Date: March 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
capsules; daily; orally
Experimental: Vortioxetine 5 mg Drug: Vortioxetine (Lu AA21004)
encapsulated tablets; daily; orally
Other Name: Brintellix
Duloxetine 60 mg
Active reference
Drug: Duloxetine
encapsulated tablets; daily; orally
Other Name: Cymbalta®

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00811252

Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  More Information

Publications:
Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT00811252     History of Changes
Other Study ID Numbers: 12541A, 2008-002901-38
Study First Received: December 17, 2008
Results First Received: October 28, 2013
Last Updated: December 23, 2013
Health Authority: Canada: Health Canada
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Sweden: Medical Products Agency
Ukraine: Ministry of Health
United States: Food and Drug Administration

Keywords provided by H. Lundbeck A/S:
Depression
Elderly
Acute treatment

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Duloxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014