Open-label Safety Extension Study of 5 and 10 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00761306
First received: September 26, 2008
Last updated: December 23, 2013
Last verified: December 2013
Results First Received: October 28, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Intervention: Drug: Vortioxetine (Lu AA21004)

  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
Patients eligible to participate in present study, NCT00761306 / 11492C, were outpatients, who had completed lead-in study NCT00839423 / 11492A immediately prior to inclusion into present study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study consisted of a 1-week, fixed-dose period with Vortioxetine 10 mg/day, a 51-week flexible dose period with Vortioxetine 5 or 10 mg/day, and a 4-week safety follow up period.

Reporting Groups
  Description
Vortioxetine 5 or 10 mg/Day tablets; orally

Participant Flow:   Overall Study
    Vortioxetine 5 or 10 mg/Day  
STARTED     74  
COMPLETED     54  
NOT COMPLETED     20  
Adverse Event                 5  
Lack of Efficacy                 4  
Protocol Violation                 2  
Withdrawal of Consent                 3  
Lost to Follow-up                 1  
Administrative or Other Reasons                 5  



  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.
Age and Sex: all-patients-treated set (APTS) - all patients who took at least one dose of Vortioxetine in Study NCT00761306 / 11492C; MADRS and HAM-D-24: full-analysis set (FAS) = 74 - all patients in the APTS who had at least one valid Baseline and one valid post-Baseline assessment of the MADRS total score in Study NCT00761306 / 11492C.

Reporting Groups
  Description
Vortioxetine 5 or 10 mg/Day tablets; orally

Baseline Measures
    Vortioxetine 5 or 10 mg/Day  
Number of Participants  
[units: participants]
  74  
Age  
[units: years]
Mean ± Standard Deviation
  44.5  ± 11.5  
Gender  
[units: participants]
 
Female     45  
Male     29  
MADRS [1]
[units: units on a scale]
Mean ± Standard Deviation
  10.7  ± 8.4  
HAM-D-24 [2]
[units: units on a scale]
Mean ± Standard Deviation
  10.2  ± 7.8  
[1] 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.
[2] The Hamilton Depression Scale - 24 Items (HAM-D-24) 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 76. The higher the score, the more severe.



  Outcome Measures
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1.  Primary:   Number of Patients With Adverse Events (AEs)   [ Time Frame: Up to 52 weeks and a 4-week safety follow-up period ]

2.  Primary:   Percentage of Patients Who Withdrew Due to Intolerance to Treatment   [ Time Frame: Baseline to Week 52 ]

3.  Secondary:   Change From Baseline in MADRS Total Score After 52 Weeks of Treatment   [ Time Frame: Baseline and Week 52 ]

4.  Secondary:   Change From Baseline in HAM-D-24 Total Score After 52 Weeks of Treatment   [ Time Frame: Baseline and Week 52 ]

5.  Secondary:   Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)   [ Time Frame: Week 52 ]

6.  Secondary:   Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)   [ Time Frame: Week 52 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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.  


Results Point of Contact:  
Name/Title: H. Lundbeck A/S
Organization: H. Lundbeck A/S
phone: +45 3630 1311
e-mail: LundbeckClinicalTrials@lundbeck.com


No publications provided


Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT00761306     History of Changes
Other Study ID Numbers: 11492C, 2007-000905-31
Study First Received: September 26, 2008
Results First Received: October 28, 2013
Last Updated: December 23, 2013
Health Authority: Australia: National Health and Medical Research Council
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
Italy: The Italian Medicines Agency
Malaysia: Ministry of Health
Slovakia: State Institute for Drug Control
Sweden: Medical Products Agency