Efficacy of Vortioxetine (Lu AA21004) in the Prevention of Relapse of Major Depressive Episodes
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Placebo
Vortioxetine (Lu AA21004)
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Relapse prevention, Antidepressants, Placebo-controlled, Double-blind, Multicentre study
Eligibility Criteria
Inclusion Criteria:
- Major Depressive Episode (MDE) as the primary diagnosis according to DSM-IV TR criteria
- At least one other MDE before the current one
- Moderate to severe depression
Exclusion Criteria:
- Any current psychiatric disorder other than Major Depressive Disorder (MDD) as defined in the DSM-IV TR
- Any substance disorder within the previous 6 months
- Female patients of childbearing potential who are not using effective contraception
- Use of any psychoactive medication 2 weeks prior to screening and during the study
Randomisation Criteria: Patients in remission (MADRS total score <=10) at both Week 10 and Week 12
Other protocol-defined inclusion and exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Vortioxetine: 5 or 10 mg
Arm Description
Outcomes
Primary Outcome Measures
Relapse Within First 24 Weeks of the Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator
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.
Secondary Outcome Measures
Relapse During the Entire Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator
Change From Double-blind Baseline in MADRS Total Score After 24 Weeks of Double-blind Treatment
Change From Double-blind Baseline in HAM-D-17 Total Score After 24 Weeks of Double-blind Treatment
The Hamilton Depression Scale - 17 items (HAM-D-17) 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 52. The higher the score, the more severe.
Change From Double-blind Baseline in HAM-A Total Score After 24 Weeks of Double-blind 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 Double-blind Baseline in CGI-S Score After 24 Weeks of Double-blind 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.
Proportion of Responders at Week 24 of the Double-blind Period (Response Defined as a >=50% Reduction in MADRS Total Score From Open-label Baseline)
Proportion of Remitters at Week 24 of the Double-blind Period (Remission Defined as a MADRS Total Score <=10)
Change From Double-blind Baseline in SDS Total Score at Week 24 of the Double-blind Period
The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00596817
Brief Title
Efficacy of Vortioxetine (Lu AA21004) in the Prevention of Relapse of Major Depressive Episodes
Official Title
A Double-blind, Randomised, Placebo-controlled, Multicentre, Relapse-prevention Study With Two Doses of [Vortioxetine] Lu AA21004 in Patients With Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
October 2009 (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
This study will evaluate the efficacy of Vortioxetine in the prevention of relapse of major depressive episodes in patients who responded to open-label treatment with Vortioxetine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Relapse prevention, Antidepressants, Placebo-controlled, Double-blind, Multicentre study
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
639 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Vortioxetine: 5 or 10 mg
Arm Type
Experimental
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
Primary Outcome Measure Information:
Title
Relapse Within First 24 Weeks of the Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator
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
Within first 24 weeks of the double-blind period
Secondary Outcome Measure Information:
Title
Relapse During the Entire Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator
Time Frame
Within 64 weeks of the double-blind period
Title
Change From Double-blind Baseline in MADRS Total Score After 24 Weeks of Double-blind Treatment
Time Frame
Double-blind Baseline and Week 24 of the double-blind period
Title
Change From Double-blind Baseline in HAM-D-17 Total Score After 24 Weeks of Double-blind Treatment
Description
The Hamilton Depression Scale - 17 items (HAM-D-17) 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 52. The higher the score, the more severe.
Time Frame
Double-blind Baseline and Week 24 of the double-blind period
Title
Change From Double-blind Baseline in HAM-A Total Score After 24 Weeks of Double-blind 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
Double-blind Baseline and Week 24 of the double-blind period
Title
Change From Double-blind Baseline in CGI-S Score After 24 Weeks of Double-blind 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
Double-blind Baseline and Week 24 of the double-blind period
Title
Proportion of Responders at Week 24 of the Double-blind Period (Response Defined as a >=50% Reduction in MADRS Total Score From Open-label Baseline)
Time Frame
Week 24 of the double-blind period (Counted From Open-label Baseline)
Title
Proportion of Remitters at Week 24 of the Double-blind Period (Remission Defined as a MADRS Total Score <=10)
Time Frame
Week 24 of the double-blind period
Title
Change From Double-blind Baseline in SDS Total Score at Week 24 of the Double-blind Period
Description
The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe.
Time Frame
Week 24 of the double-blind period (Counted From Double-blind Baseline)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Major Depressive Episode (MDE) as the primary diagnosis according to DSM-IV TR criteria
At least one other MDE before the current one
Moderate to severe depression
Exclusion Criteria:
Any current psychiatric disorder other than Major Depressive Disorder (MDD) as defined in the DSM-IV TR
Any substance disorder within the previous 6 months
Female patients of childbearing potential who are not using effective contraception
Use of any psychoactive medication 2 weeks prior to screening and during the study
Randomisation Criteria: Patients in remission (MADRS total score <=10) at both Week 10 and Week 12
Other protocol-defined 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
22495621
Citation
Boulenger JP, Loft H, Florea I. A randomized clinical study of Lu AA21004 in the prevention of relapse in patients with major depressive disorder. J Psychopharmacol. 2012 Nov;26(11):1408-16. doi: 10.1177/0269881112441866. Epub 2012 Apr 9.
Results Reference
result
PubMed Identifier
31818787
Citation
Christensen MC, Florea I, Loft H, McIntyre RS. Efficacy of vortioxetine in patients with major depressive disorder reporting childhood or recent trauma. J Affect Disord. 2020 Feb 15;263:258-266. doi: 10.1016/j.jad.2019.11.074. Epub 2019 Nov 13.
Results Reference
derived
PubMed Identifier
27780334
Citation
McIntyre RS, Florea I, Tonnoir B, Loft H, Lam RW, Christensen MC. Efficacy of Vortioxetine on Cognitive Functioning in Working Patients With Major Depressive Disorder. J Clin Psychiatry. 2017 Jan;78(1):115-121. doi: 10.4088/JCP.16m10744.
Results Reference
derived
Learn more about this trial
Efficacy of Vortioxetine (Lu AA21004) in the Prevention of Relapse of Major Depressive Episodes
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