Back to resultsRandomised 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
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Placebo
Vortioxetine (Lu AA21004)
Duloxetine
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression, Elderly, Acute treatment
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Other
Arm Label
Placebo
Vortioxetine 5 mg
Duloxetine 60 mg
Arm Description
Active reference
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change From Baseline in HAM-D-24 Total Score After 6 Weeks of Treatment
Change From Baseline in HAM-D-24 Total Score After 4 Weeks of Treatment
Change From Baseline in HAM-D-24 Total Score After 2 Weeks of Treatment
Change From Baseline in HAM-D-24 Total Score After 1 Week of Treatment
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.
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.
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.
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.
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.
Proportion of Responders at Week 8 (Response Defined as a >=50% Reduction in the HAM-D-24 Total Score)
Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00811252
Brief Title
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
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Depression, Elderly, Acute treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
453 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Vortioxetine 5 mg
Arm Type
Experimental
Arm Title
Duloxetine 60 mg
Arm Type
Other
Arm Description
Active reference
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
capsules; daily; orally
Intervention Type
Drug
Intervention Name(s)
Vortioxetine (Lu AA21004)
Other Intervention Name(s)
Brintellix
Intervention Description
encapsulated tablets; daily; orally
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Other Intervention Name(s)
Cymbalta®
Intervention Description
encapsulated tablets; daily; orally
Primary Outcome Measure Information:
Title
Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment
Description
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.
Time Frame
Baseline and Week 8
Secondary Outcome Measure Information:
Title
Change From Baseline in HAM-D-24 Total Score After 6 Weeks of Treatment
Time Frame
Baseline and Week 6
Title
Change From Baseline in HAM-D-24 Total Score After 4 Weeks of Treatment
Time Frame
Baseline and Week 4
Title
Change From Baseline in HAM-D-24 Total Score After 2 Weeks of Treatment
Time Frame
Baseline and Week 2
Title
Change From Baseline in HAM-D-24 Total Score After 1 Week of Treatment
Time Frame
Baseline and Week 1
Title
Change From Baseline in MADRS Total Score After 8 Weeks of Treatment
Description
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.
Time Frame
Baseline and Week 8
Title
Change From Baseline in HAM-A Total Score After 8 Weeks of Treatment
Description
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.
Time Frame
Baseline and Week 8
Title
Change From Baseline in CGI-S Score After 8 Weeks of Treatment
Description
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.
Time Frame
Baseline and Week 8
Title
Change in Clinical Status Using CGI-I Score at Week 8
Description
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.
Time Frame
Week 8
Title
Change From Baseline in GDS Total Score After 8 Weeks of Treatment
Description
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.
Time Frame
Baseline and Week 8
Title
Proportion of Responders at Week 8 (Response Defined as a >=50% Reduction in the HAM-D-24 Total Score)
Time Frame
Week 8
Title
Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10)
Time Frame
Week 8
Title
Risk of Suicidality Using C-SSRS Scores
Description
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.
Time Frame
Up to 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@lundbeck.com
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
22572889
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.
Results Reference
result
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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
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