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Efficacy Study 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:
NCT00735709
First received: August 14, 2008
Last updated: October 25, 2013
Last verified: October 2013
Results First Received: October 25, 2013  
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
Drug: Placebo

  Participant Flow
  Hide Participant Flow

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 51 investigative sites in Australia, Croatia, France, Germany, Latvia, Lithuania, Malaysia, Netherlands, Poland, Republic of Korea, Russia, South Africa, Taiwan, and Ukraine from 14 August 2008 to 13 August 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with a diagnosis of major depressive disorder were randomized equally in 1 of 4 treatment groups, once daily placebo, 1 mg, 5 mg, or 10 mg vortioxetine.

Reporting Groups
  Description
Placebo Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 1 mg Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 5 mg Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 10 mg Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.

Participant Flow:   Overall Study
    Placebo   Vortioxetine 1 mg   Vortioxetine 5 mg   Vortioxetine 10 mg
STARTED   140   140   140   140 
Treated   140   140   140   139 
COMPLETED   127   127   129   122 
NOT COMPLETED   13   13   11   18 
Adverse Event                2                3                1                5 
Lack of Efficacy                8                4                2                3 
Noncompliance                0                0                1                0 
Protocol deviations                1                2                1                1 
Voluntary Withdrawal                1                3                5                7 
Lost to Follow-up                0                1                1                1 
Excluded medication                1                0                0                1 



  Baseline Characteristics
  Hide 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.
No text entered.

Reporting Groups
  Description
Placebo Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 1 mg Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 5 mg Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 10 mg Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Total Total of all reporting groups

Baseline Measures
   Placebo   Vortioxetine 1 mg   Vortioxetine 5 mg   Vortioxetine 10 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 140   140   140   140   560 
Age 
[Units: Years]
Mean (Standard Deviation)
 46.4  (12.26)   45.4  (11.89)   47.3  (11.95)   46.4  (12.27)   46.4  (12.08) 
Age, Customized 
[Units: Participants]
         
≤55 years   103   110   102   107   422 
>55 years   37   30   38   33   138 
Gender 
[Units: Participants]
         
Female   86   93   87   85   351 
Male   54   47   53   55   209 
Race/Ethnicity, Customized 
[Units: Participants]
         
Caucasian   120   129   120   114   483 
Black   5   1   2   2   10 
Asian   14   8   17   23   62 
Other   1   2   1   1   5 
Race/Ethnicity, Customized 
[Units: Participants]
         
Hispanic/Latino   3   0   0   1   4 
Non-Hispanic/Non-Latino   137   140   140   139   556 
Region of Enrollment 
[Units: Participants]
         
Australia   0   3   0   1   4 
Croatia   2   5   5   1   13 
France   5   2   1   5   13 
Germany   63   50   64   56   233 
Latvia   5   8   9   5   27 
Lithuania   4   4   2   3   13 
Malaysia   7   3   6   6   22 
Netherlands   0   3   3   1   7 
Poland   20   16   15   11   62 
Republic of Korea   7   5   9   14   35 
Russia   12   20   9   20   61 
South Africa   5   6   5   3   19 
Taiwan   0   0   1   3   4 
Ukraine   10   15   11   11   47 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 75.18  (14.924)   75.63  (17.276)   75.41  (17.022)   74.58  (15.190)   75.20  (16.099) 
Height 
[Units: Cm]
Mean (Standard Deviation)
 168.70  (8.907)   168.56  (8.264)   168.56  (9.126)   168.70  (10.209)   168.63  (9.129) 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 26.36  (4.615)   26.53  (5.380)   26.41  (5.065)   26.16  (4.612)   26.36  (4.917) 
Smoking Classification 
[Units: Participants]
         
Never smoked   88   74   88   79   329 
Current smoker   34   54   33   41   162 
Ex-smoker   18   12   19   20   69 
Alcohol Consumption 
[Units: Participants]
         
Never   53   51   56   54   214 
Once monthly or less often   57   60   59   51   227 
Once per week   16   13   9   16   54 
2-to-6 times/week   5   11   7   12   35 
Daily   9   5   9   7   30 
24-item Hamilton Depression Scale total score [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 32.7  (4.40)   32.5  (5.13)   32.1  (5.04)   33.1  (4.77)   32.6  (4.84) 
[1] 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.
Montgomery Åsberg Depression Rating Scale (MADRS) total score [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 30.6  (2.89)   30.4  (3.01)   30.6  (2.83)   31.6  (3.83)   30.8  (3.19) 
[1] 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).
Hamilton Anxiety Scale total score [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 19.7  (7.07)   20.0  (6.41)   19.4  (6.77)   21.1  (7.39)   20.0  (6.93) 
[1] 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.
Clinical Global Impression - Severity scale score [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 4.8  (0.80)   4.7  (0.73)   4.8  (0.73)   4.9  (0.76)   4.8  (0.76) 
[1] 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.
Hospital Anxiety and Depression (HAD) – Anxiety subscale [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 11.2  (3.99)   11.2  (3.83)   11.6  (4.02)   11.7  (3.97)   11.4  (3.95) 
[1] The HAD-anxiety subscale is completed by the participant and measures anxiety, including anxious mood, restlessness, anxious thoughts, and panic attacks. The subscale is made up of 7 items that are assessed on a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores are summed and range from 0 to 21 (maximal severity).
Hospital Anxiety and Depression – Depression subscale [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 13.7  (4.33)   13.8  (3.88)   13.4  (4.02)   13.8  (3.71)   13.7  (3.99) 
[1] The HAD - Depression subscale is completed by the participant and measures depression, focusing on the state of lost interest and diminished pleasure response. The subscale is made up of 7 items that are assessed on a scale from 0 (no depression) to 3 (severe feeling of depression). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. The item scores are summed and the total subscore ranges from 0 to 21 (maximal severity).


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in the 24-item Hamilton Depression Scale Total Score At Week 8   [ Time Frame: Baseline to Week 8 ]

2.  Secondary:   Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8   [ Time Frame: Baseline to Week 8 ]

3.  Secondary:   Clinical Global Impression Scale-Global Improvement at Week 8   [ Time Frame: Baseline to Week 8 ]

4.  Secondary:   Percentage of Responders in HAM-D24 Total Score at Week 8   [ Time Frame: Baseline and Week 8 ]

5.  Secondary:   Change From Baseline in HAM-D24 Total Score at Week 8 in Participants With Baseline HAM-A Score ≥20   [ Time Frame: Baseline to Week 8 ]

6.  Secondary:   Percentage of Participants in MADRS Remission at Week 8   [ Time Frame: Week 8 ]

7.  Secondary:   Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed   [ Time Frame: Baseline and Weeks 1, 2, 4 and 6 ]

8.  Secondary:   Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed   [ Time Frame: Baseline and Weeks 1, 2 and 6 ]

9.  Secondary:   Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed   [ Time Frame: Baseline and Weeks 1, 2, 4 and 6 ]

10.  Secondary:   Percentage of Responders in HAM-D24 Total Score at Other Weeks Assessed   [ Time Frame: Baseline and Weeks 1, 2, 4 and 6 ]

11.  Secondary:   Change From Baseline in HAM-D24 Total Score at Other Weeks Assessed in Participants With a Baseline HAM-A Score ≥20   [ Time Frame: Baseline and Weeks 1, 2, 4 and 6 ]

12.  Secondary:   Percentage of Participants in MADRS Remission at Other Weeks Assessed   [ Time Frame: Weeks 1, 2, 4 and 6 ]

13.  Secondary:   Percentage of Participants With a Sustained Response in HAM-D24 Total Score   [ Time Frame: From Baseline through Week 8 ]

14.  Secondary:   Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Each Week   [ Time Frame: Baseline and Weeks 1, 2, 4, 6, and 8 ]

15.  Secondary:   Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Each Week Assessed   [ Time Frame: Baseline and Weeks 1, 2, 4, 6, and 8 ]

16.  Secondary:   Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed   [ Time Frame: Baseline and Weeks 1, 2, 4, 6, and 8 ]

17.  Secondary:   Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed   [ Time Frame: Baseline and Weeks 1, 4, and 8 ]

18.  Secondary:   Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at All Weeks Assessed   [ Time Frame: Baseline and Weeks 2, 4 and 8 ]

19.  Secondary:   Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at All Weeks Assessed   [ Time Frame: Baseline and Weeks 2, 4 and 8 ]

20.  Secondary:   Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at All Weeks Assessed   [ Time Frame: Baseline and Weeks 2, 4 and 8 ]

21.  Secondary:   Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at All Weeks Assessed   [ Time Frame: Baseline and Weeks 2, 4 and 8 ]

22.  Secondary:   Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at All Weeks Assessed   [ Time Frame: Baseline and Weeks 2, 4 and 8 ]

23.  Secondary:   Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed   [ Time Frame: Baseline and Weeks 2 and 4 ]

24.  Secondary:   Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at All Weeks Assessed   [ Time Frame: Baseline and Weeks 2, 4 and 8 ]

25.  Secondary:   Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at All Weeks Assessed   [ Time Frame: Baseline and Weeks 2, 4 and 8 ]

26.  Secondary:   Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire.   [ Time Frame: Baseline and Week 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
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  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


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

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00735709     History of Changes
Other Study ID Numbers: LuAA21004_305
2008-001580-11 ( EudraCT Number )
U1111-1114-0326 ( Registry Identifier: WHO )
Study First Received: August 14, 2008
Results First Received: October 25, 2013
Last Updated: October 25, 2013