Study of Vortioxetine (Lu AA21004) in Major Depressive Disorder in Asian Countries
|ClinicalTrials.gov Identifier: NCT01571453|
Recruitment Status : Completed
First Posted : April 5, 2012
Results First Posted : October 13, 2014
Last Update Posted : October 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: Vortioxetine (Lu AA21004) Drug: Venlafaxine extended release||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||437 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Randomised, Double-blind, Parallel-group, Active-comparator (Venlafaxine Extended Release), Fixed-dose Study of [Vortioxetine] Lu AA21004 in Major Depressive Disorder in Asian Countries|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||October 2013|
|Experimental: Vortioxetine (Lu AA21004)||
Drug: Vortioxetine (Lu AA21004)
Other Name: Brintellix
|Active Comparator: Venlafaxine extended release||
Drug: Venlafaxine extended release
Other Name: Efexor® XL
- Change From Baseline in MADRS Total Score at Week 8 [ Time Frame: Baseline and Week 8 ]Montgomery and Asberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. The total score of the ten items ranges from 0 to 60. The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
- Change in CGI-S Score From Baseline to Week 8 [ Time Frame: Baseline and Week 8 ]Clinical Global Impression Scale - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). Higher score indicates that the subject is more ill, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
- CGI-I Score at Week 8 [ Time Frame: Week 8 ]The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not. Higher score = more affected.
- Change in HAM-A Total Score From Baseline to Week 8 [ Time Frame: Baseline and Week 8 ]Hamilton Anxiety Rating Scale (HAM-A) is a 14-item rating scale designed to assess the global anxiety. Each symptom is rated from 0 (absent) to 4 (maximum severity). The total score of the 14 items ranges from 0 to 56. Higher score indicates greater anxiety, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
- MADRS Response at Week 8 (Response Defined as a ≥50% Decrease in the MADRS Total Score From Baseline) [ Time Frame: Week 8 ]
- Remission at Week 8 (Remission Defined as a MADRS Total Score ≤10) [ Time Frame: Week 8 ]
- Number of Adverse Events [ Time Frame: Baseline to Week 12 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01571453
|Study Director:||Email contact via H. Lundbeck A/S||LundbeckClinicalTrials@lundbeck.com|