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Safety and Tolerability of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder

This study has been completed.
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT00707980
First received: June 27, 2008
Last updated: October 24, 2013
Last verified: October 2013
Results First Received: October 24, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Intervention: Drug: Vortioxetine

  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
Participants took part in the study at 88 investigative sites in Australia, Croatia, France, Germany, Korea, Latvia, Lithuania, Malaysia, The Netherlands, Poland, Russia, Taiwan, Ukraine, and the United States from 17 June 2008 to 23 August 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants who completed short-term efficacy and safety studies Lu AA21004_304 (NCT00672620) and LuAA21004_305 (NCT00735709) were eligible to receive the 52-week treatment with vortioxetine in this open-label extension study.

Reporting Groups
  Description
Vortioxetine Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.

Participant Flow:   Overall Study
    Vortioxetine  
STARTED     836  
Received Treatment     834  
COMPLETED     526  
NOT COMPLETED     310  
Adverse Event                 49  
Lack of Efficacy                 35  
Non-Compliance with Study Drug                 28  
Protocol Deviations                 19  
Withdrawal of Consent                 81  
Lost to Follow-up                 59  
Other                 39  



  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.
No text entered.

Reporting Groups
  Description
Vortioxetine Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.

Baseline Measures
    Vortioxetine  
Number of Participants  
[units: participants]
  836  
Age  
[units: Years]
Mean ± Standard Deviation
  45.5  ± 12.78  
Age, Customized  
[units: Participants]
 
≤55 years     636  
>55 years     200  
Gender [1]
[units: Participants]
 
Female     526  
Male     310  
Race/Ethnicity, Customized  
[units: Participants]
 
Caucasian (White, including Hispanic)     693  
Black     86  
Asian     54  
American Indian or Alaska Native     2  
Native Hawaiian/ Other Pacific Islander     1  
Race/Ethnicity, Customized [2]
[units: Participants]
 
Hispanic/Latino     53  
Non-Hispanic/Non-Latino     782  
Missing     1  
Region of Enrollment  
[units: Participants]
 
Australia     4  
Germany     207  
France     11  
Croatia     11  
Republic of Korea     25  
Lithuania     10  
Latvia     20  
Malaysia     17  
Netherlands     7  
Poland     57  
Russia     40  
Taiwan     3  
Ukraine     37  
United States     387  
Weight  
[units: kg]
Mean ± Standard Deviation
  81.16  ± 20.829  
Height  
[units: cm]
Mean ± Standard Deviation
  169.00  ± 9.777  
Body Mass Index (BMI)  
[units: kg/m^2]
Mean ± Standard Deviation
  28.41  ± 7.074  
24-item Hamilton Depression Scale total score [3]
[units: scores on a scale]
Mean ± Standard Deviation
  17.6  ± 9.40  
Montgomery Åsberg Depression Rating Scale (MADRS) total score [4]
[units: scores on a scale]
Mean ± Standard Deviation
  16.6  ± 9.24  
Hamilton Anxiety Scale total score [5]
[units: scores on a scale]
Mean ± Standard Deviation
  12.1  ± 7.17  
Clinical Global Impression - Severity scale score [6]
[units: scores on a scale]
Mean ± Standard Deviation
  3.2  ± 1.26  
[1] Note: Baseline refers to the open-label extension study baseline throughout these results.
[2] Race data available for 836 participants.
[3] The 24-item Hamilton Depression Scale (HAM-D24) is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74, where a higher score indicates a greater depressive state.
[4] The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression).
[5] Hamilton Anxiety Scale (HAM-A) is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior 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 scores range from 0 to 56, where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety.
[6] The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale where the clinician rates the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.



  Outcome Measures
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1.  Primary:   Physical Examination Findings   [ Time Frame: Baseline and Week 52 ]

2.  Primary:   Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings   [ Time Frame: Weeks 4, 8, 12, 20, 28, 36, 44 and 52 ]

3.  Primary:   Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings   [ Time Frame: Weeks 4, 12, 24, 36 and 52 ]

4.  Primary:   Number of Participants With Adverse Events (AEs)   [ Time Frame: From the first dose of open-label study drug until 4 weeks after the last dose (up to 56 weeks) ]

5.  Primary:   Number of Participants With Potentially Clinically Significant Vital Sign Findings   [ Time Frame: Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 36, 44 and 52 ]

6.  Secondary:   Change From Baseline in Hamilton Depression Scale-24 Item (HAM-D24) Total Score   [ Time Frame: Baseline and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 36, 44 and 52. ]

7.  Secondary:   Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score   [ Time Frame: Baseline and Weeks 4, 24 and 52 ]

8.  Secondary:   Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score   [ Time Frame: Baseline and Weeks 4, 24 and 52 ]

9.  Secondary:   Change From Baseline in the Clinical Global Impression of Severity of Illness Scale   [ Time Frame: Baseline and Weeks 4, 24 and 52 ]

10.  Secondary:   Change From Baseline to the Final Visit in 36-item Short-form Health Survey (SF-36)   [ Time Frame: Baseline and Week 52 ]

11.  Secondary:   Change From Baseline to the Final Visit in the Sheehan Disability Scale   [ Time Frame: Baseline and Week 52 ]

12.  Secondary:   Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire   [ Time Frame: Baseline and Week 52 ]


  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 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.


Results Point of Contact:  
Name/Title: Medical Director, Clinical Science
Organization: Takeda
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.com


No publications provided


Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00707980     History of Changes
Other Study ID Numbers: LuAA21004_301, 2008-001581-91, U1111-1113-9564
Study First Received: June 27, 2008
Results First Received: October 24, 2013
Last Updated: October 24, 2013
Health Authority: United States: Food and Drug Administration