Study of Vortioxetine (Lu AA21004) in Major Depressive Disorder in Asian Countries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01571453
Recruitment Status : Completed
First Posted : April 5, 2012
Results First Posted : October 13, 2014
Last Update Posted : October 13, 2014
Information provided by (Responsible Party):
H. Lundbeck A/S

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Interventions: Drug: Vortioxetine (Lu AA21004)
Drug: Venlafaxine extended release

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
In- or outpatients with a primary diagnosis of recurrent of Major Depressive Disorder (MDD) were recruited for this study from China, South Korea, Taiwan, and Thailand.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A Screening Visit was held approximately 7 days prior to group assignment (group assignment was held during the Baseline Visit). Patients who met each of the inclusion criteria at the Screening and Baseline Visits and none of the exclusion criteria at the Screening and/or Baseline Visit were eligible to participate in this study.

Reporting Groups
Vortioxetine Vortioxetine (Lu AA21004): 10 mg/day
Venlafaxine Venlafaxine extended release 150 mg/day

Participant Flow:   Overall Study
    Vortioxetine   Venlafaxine
STARTED   211   226 
COMPLETED   173   164 
NOT COMPLETED   38   62 
Adverse Event                14                32 
Lack of Efficacy                8                3 
Non-compliance                2                4 
Protocol Violation                1                5 
Withdrawal of consent                5                13 
Lost to Follow-up                4                2 
Administrative or other reason(s)                4                3 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

The all-patients-treated set (APTS) comprises all randomized patients who took at least one dose of IMP.

Baseline age and gender is based on the APTS. Baseline efficacy outcome measures is based on the full-analysis set (FAS).

Reporting Groups
Vortioxetine Vortioxetine (Lu AA21004): 10 mg/day
Venlafaxine Venlafaxine extended release: 150 mg/day
Total Total of all reporting groups

Baseline Measures
   Vortioxetine   Venlafaxine   Total 
Overall Participants Analyzed 
[Units: Participants]
 211   226   437 
[Units: Years]
Mean (Standard Deviation)
 39.6  (12.4)   40.7  (12.3)   40.1  (12.3) 
[Units: Participants]
Female   123   139   262 
Male   88   87   175 
MADRS total score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 32.3  (4.6)   32.3  (4.5)   32.3  (4.6) 
[1] 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.
HAM-A total score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 20.6  (7.3)   21.1  (7.0)   20.9  (7.1) 
[1] 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. Total score from 0 to 56; higher score indicates greater anxiety.
CGI-S score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 4.8  (0.7)   4.9  (0.7)   4.9  (0.7) 
[1] 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 patient is more ill.

  Outcome Measures

1.  Primary:   Change From Baseline in MADRS Total Score at Week 8   [ Time Frame: Baseline and Week 8 ]

2.  Secondary:   Change in CGI-S Score From Baseline to Week 8   [ Time Frame: Baseline and Week 8 ]

3.  Secondary:   CGI-I Score at Week 8   [ Time Frame: Week 8 ]

4.  Secondary:   Change in HAM-A Total Score From Baseline to Week 8   [ Time Frame: Baseline and Week 8 ]

5.  Secondary:   MADRS Response at Week 8 (Response Defined as a ≥50% Decrease in the MADRS Total Score From Baseline)   [ Time Frame: Week 8 ]

6.  Secondary:   Remission at Week 8 (Remission Defined as a MADRS Total Score ≤10)   [ Time Frame: Week 8 ]

7.  Secondary:   Number of Adverse Events   [ Time Frame: Baseline to Week 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Email contact via H. Lundbeck A/S
Organization: Study Director

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: H. Lundbeck A/S Identifier: NCT01571453     History of Changes
Other Study ID Numbers: 13926A
First Submitted: March 28, 2012
First Posted: April 5, 2012
Results First Submitted: October 6, 2014
Results First Posted: October 13, 2014
Last Update Posted: October 13, 2014