Randomised Placebo-controlled Venlafaxine-referenced Study of Efficacy and Safety of 5 and 10 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Adults
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Placebo
Vortioxetine (Lu AA21004)
Venlafaxine XL
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major depressive disorder, Placebo-controlled, Active reference, Multicenter study, Randomised study, Acute treatment
Eligibility Criteria
Inclusion Criteria:
- MDE as primary diagnosis according to DSM-IV-TR criteria (classification code 296.xx)
- Current MDE duration of at least 3 months and less than 12 months
- The patient has a MADRS total score >=30
Exclusion Criteria:
- Any current psychiatric disorder other than 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
Other protocol-defined inclusion and exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Other
Arm Label
Placebo
Vortioxetine (Lu AA21004) 5 mg
Vortioxetine (Lu AA21004) 10 mg
Venlafaxine XL 225 mg
Arm Description
Active Reference
Outcomes
Primary Outcome Measures
Change From Baseline in MADRS Total Score After 6 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.
Secondary Outcome Measures
Change From Baseline in MADRS Total Score After 1 Week of Treatment
Change From Baseline in HAM-D 24 Total Score After 6 Weeks of Treatment
The 24-item Hamilton Depression Rating Scale (HAM-D) is based on the 21-item HAM-D plus an additional 3 items (helplessness, hopelessness, and worthlessness). The observer makes his/her assessment on the basis of a specific statement, content, tone, facial expression, and gestures of the patient during the interview, and scores each item from 0 to 2 or 0 to 4. Total score from 0 to 76. The higher the score, the more severe.
Change From Baseline in HAM-A Total Score After 6 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 6 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 6
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.
Proportion of Responders at Week 6 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)
Proportion of Remitters at Week 6 (Remission is Defined as a MADRS Total Score <=10)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00839423
Brief Title
Randomised Placebo-controlled Venlafaxine-referenced Study of Efficacy and Safety of 5 and 10 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Adults
Official Title
Double-blind, Randomised, Placebo-controlled Study Comparing the Efficacy and Safety of Two Fixed Dosages of a Novel Antidepressant Compound to That of Placebo in Patients With Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
September 2007 (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
The purpose of this Venlafaxine-referenced study is to evaluate the efficacy, safety and tolerability of two fixed doses of Vortioxetine in the acute treatment of Major Depressive Disorder (MDD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major depressive disorder, Placebo-controlled, Active reference, Multicenter study, Randomised study, Acute treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
426 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Vortioxetine (Lu AA21004) 5 mg
Arm Type
Experimental
Arm Title
Vortioxetine (Lu AA21004) 10 mg
Arm Type
Experimental
Arm Title
Venlafaxine XL 225 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)
Venlafaxine XL
Other Intervention Name(s)
Effexor®
Intervention Description
capsules, daily, orally
Primary Outcome Measure Information:
Title
Change From Baseline in MADRS Total Score After 6 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 6
Secondary Outcome Measure Information:
Title
Change From Baseline in MADRS Total Score After 1 Week of Treatment
Time Frame
Baseline and Week 1
Title
Change From Baseline in HAM-D 24 Total Score After 6 Weeks of Treatment
Description
The 24-item Hamilton Depression Rating Scale (HAM-D) is based on the 21-item HAM-D plus an additional 3 items (helplessness, hopelessness, and worthlessness). The observer makes his/her assessment on the basis of a specific statement, content, tone, facial expression, and gestures of the patient during the interview, and scores each item from 0 to 2 or 0 to 4. Total score from 0 to 76. The higher the score, the more severe.
Time Frame
Baseline and Week 6
Title
Change From Baseline in HAM-A Total Score After 6 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 6
Title
Change From Baseline in CGI-S Score After 6 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 6
Title
Change in Clinical Status Using CGI-I Score at Week 6
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 6
Title
Proportion of Responders at Week 6 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)
Time Frame
Week 6
Title
Proportion of Remitters at Week 6 (Remission is Defined as a MADRS Total Score <=10)
Time Frame
Week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
MDE as primary diagnosis according to DSM-IV-TR criteria (classification code 296.xx)
Current MDE duration of at least 3 months and less than 12 months
The patient has a MADRS total score >=30
Exclusion Criteria:
Any current psychiatric disorder other than 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
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
21767441
Citation
Alvarez E, Perez V, Dragheim M, Loft H, Artigas F. A double-blind, randomized, placebo-controlled, active reference study of Lu AA21004 in patients with major depressive disorder. Int J Neuropsychopharmacol. 2012 Jun;15(5):589-600. doi: 10.1017/S1461145711001027. Epub 2011 Jul 18.
Results Reference
result
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Randomised Placebo-controlled Venlafaxine-referenced Study of Efficacy and Safety of 5 and 10 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Adults
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