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Efficacy and Safety Study of Vortioxetine (Lu AA21004) for Treatment of Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01255787
First received: December 6, 2010
Last updated: October 25, 2013
Last verified: October 2013
Results First Received: October 25, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Depressive Disorder, Major
Interventions: Drug: Vortioxetine
Drug: Placebo

  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 90 investigative sites in Japan, Europe and Asia/Oceania from 18 November 2010 to 25 April 2012.

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 enrolled equally in 1 of 4 treatment groups, once a day placebo, 5 mg, 10 mg, or 20 mg vortioxetine.

Reporting Groups
  Description
Placebo Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
Vortioxetine 5 mg Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
Vortioxetine 10 mg Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
Vortioxetine 20 mg Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.

Participant Flow:   Overall Study
    Placebo   Vortioxetine 5 mg   Vortioxetine 10 mg   Vortioxetine 20 mg
STARTED   152   144   150   154 
Treated   152   144   148   150 
COMPLETED   136   127   132   132 
NOT COMPLETED   16   17   18   22 
Pretreatment Event or Adverse Event (AE)                6                2                9                9 
Major Protocol Deviation                1                1                0                4 
Lost to Follow-up                1                2                4                2 
Withdrawal of Consent                3                9                3                4 
Pregnancy                0                0                0                1 
Lack of Efficacy                2                2                2                2 
Noncompliance with Study Drug                3                1                0                0 



  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
Placebo Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
Vortioxetine 5 mg Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
Vortioxetine 10 mg Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
Vortioxetine 20 mg Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
Total Total of all reporting groups

Baseline Measures
   Placebo   Vortioxetine 5 mg   Vortioxetine 10 mg   Vortioxetine 20 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 152   144   150   154   600 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.6  (11.57)   44.2  (11.89)   45.7  (10.90)   44.0  (11.79)   44.4  (11.54) 
Gender 
[Units: Participants]
         
Female   91   98   93   93   375 
Male   61   46   57   61   225 
Race/Ethnicity, Customized 
[Units: Participants]
         
Caucasian (or White, including Hispanic)   104   101   104   105   414 
Asian   48   43   46   49   186 
Region of Enrollment 
[Units: Participants]
         
Croatia   0   1   0   2   3 
Finland   5   5   5   5   20 
Germany   50   50   50   49   199 
India   3   3   3   2   11 
Japan   33   32   31   33   129 
Latvia   3   2   2   3   10 
Malaysia   2   0   0   2   4 
Philippines   4   2   4   3   13 
Poland   20   18   20   21   79 
Romania   5   4   6   3   18 
Russia   13   13   12   13   51 
Serbia   2   2   3   2   9 
South Korea   6   6   7   8   27 
Ukraine   6   6   7   8   27 
Height 
[Units: Cm]
Mean (Standard Deviation)
 167.1  (8.75)   167.2  (9.64)   167.5  (9.40)   167.5  (9.61)   167.3  (9.33) 
Weight [1] 
[Units: Kg]
Mean (Standard Deviation)
 69.70  (16.901)   70.57  (18.214)   73.37  (19.014)   70.21  (18.189)   70.95  (18.095) 
[1] Number of participants for whom weight data were available were 152, 144, 147 and 149 in each treatment group respectively.
Body Mass Index (BMI) [1] 
[Units: Kg/m^2]
Mean (Standard Deviation)
 24.82  (5.129)   25.06  (5.432)   25.93  (5.462)   24.82  (5.206)   25.15  (5.313) 
[1] Number of participants for whom BMI data were available were 152, 144, 147 and 149 in each treatment group respectively.
Smoking Classification 
[Units: Participants]
         
Current smoker   51   50   50   56   207 
Ex-smoker   22   19   21   11   73 
Never smoked   79   75   79   87   320 
History of Alcohol Consumption 
[Units: Participants]
         
Never   58   62   54   56   230 
Once monthly or less often   52   41   54   53   200 
Once a week   17   22   22   22   83 
2 to 6 times per week   14   9   10   13   46 
Daily   11   10   10   10   41 
Status of Major Depressive Episode (MDE) [1] 
[Units: Participants]
         
Single episode   51   55   49   49   204 
Recurrent episode   101   89   101   105   396 
[1] An MDE is a period marked by depressed mood, loss of interest or pleasure, disturbed sleep or appetite, low energy, feelings of guilt or low self-worth, and poor concentration.
Pharmacotherapy for Current Major Depressive Episode 
[Units: Participants]
         
Yes   73   60   69   75   277 
No   79   84   81   79   323 
Montgomery Åsberg Depression Rating Scale (MADRS) Total Score [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 31.6  (3.56)   31.6  (3.67)   31.8  (4.02)   31.7  (3.73)   31.7  (3.74) 
[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).

Number of participants for whom MADRS data were available were 152, 144, 147 and 149 in each treatment arm respectively.

Clinical Global Impression - Severity scale score [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 4.7  (0.66)   4.7  (0.65)   4.7  (0.66)   4.7  (0.65)   4.70  (0.65) 
[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. Number of participants for whom CGI-S data were available were 152, 144, 147 and 149 in each treatment arm respectively.
Sheehan Disability Scale (SDS) - Total score [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 18.2  (5.28)   17.9  (6.27)   18.5  (5.42)   18.2  (5.70)   18.2  (5.65) 
[1] The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. Number of participants for whom SDS data were available were 132, 116, 119 and 121 in each treatment arm respectively.
Hamilton Anxiety Scale Total Score [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 18.6  (6.83)   18.9  (6.55)   18.8  (6.66)   18.5  (6.12)   18.7  (6.53) 
[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 (absent) to 56 (maximum severity). Number of participants for whom HAM-A data were available were 152, 144, 148 and 150 in each treatment arm respectively.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score   [ Time Frame: Baseline and Week 8 ]

2.  Secondary:   Percentage of Participants With a MADRS Response at Week 8   [ Time Frame: Baseline and Week 8 ]

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

4.  Secondary:   Mean Clinical Global Impression Scale - Improvement (CGI-I) Score at Week 8   [ Time Frame: Week 8 ]

5.  Secondary:   Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8   [ 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
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



Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01255787     History of Changes
Other Study ID Numbers: LuAA21004/CCT-002
2010-022257-41 ( EudraCT Number )
U1111-1117-6595 ( Registry Identifier: WHO )
JapicCTI-101344 ( Registry Identifier: JapicCTI )
CTRI/2011/08/001963 ( Registry Identifier: CTRI )
Study First Received: December 6, 2010
Results First Received: October 25, 2013
Last Updated: October 25, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency
Croatia: Agency for Medicinal Product and Medical Devices
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Latvia: State Agency of Medicines
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Agency for Medicines and Medical Devices
Russia: Department of State Regulation of Circulation of Medical Remedies
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Ukraine: State Pharmacological Center - Ministry of Health
Hong Kong: Department of Health
India: Drugs Controller General of India
South Korea: Korea Food and Drug Administration (KFDA)
Malaysia: National Pharmaceutical Control Bureau
Philippines : Food and Drug Administration
Taiwan: Taiwan Food and Drug Administration