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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT01571453
First received: March 28, 2012
Last updated: October 6, 2014
Last verified: October 2014
Results First Received: October 6, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Interventions: Drug: Vortioxetine (Lu AA21004)
Drug: Venlafaxine extended release

  Participant Flow
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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
  Description
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
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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
  Description
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  
Number of Participants  
[units: participants]
  211     226     437  
Age  
[units: years]
Mean ± Standard Deviation
  39.6  ± 12.4     40.7  ± 12.3     40.1  ± 12.3  
Gender  
[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  
HAM-A total score [2]
[units: units on a scale]
Mean ± Standard Deviation
  20.6  ± 7.3     21.1  ± 7.0     20.9  ± 7.1  
CGI-S score [3]
[units: units on a scale]
Mean ± Standard Deviation
  4.8  ± 0.7     4.9  ± 0.7     4.9  ± 0.7  
[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.
[2] 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.
[3] 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
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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.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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
e-mail: LundbeckClinicalTrials@lundbeck.com


No publications provided


Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01571453     History of Changes
Other Study ID Numbers: 13926A
Study First Received: March 28, 2012
Results First Received: October 6, 2014
Last Updated: October 6, 2014
Health Authority: Korea: Food and Drug Administration
Taiwan : Food and Drug Administration
China: Food and Drug Administration
Thailand: Food and Drug Administration