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

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ClinicalTrials.gov Identifier: NCT01163266
Recruitment Status : Completed
First Posted : July 15, 2010
Results First Posted : December 18, 2013
Last Update Posted : December 18, 2013
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Depressive Disorder, Major
Interventions: Drug: Vortioxetine
Drug: Placebo

  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 37 investigative sites in the United States from 15 July 2010 to 17 January 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 3 treatment groups, once a day placebo, 10 mg, or 20 mg vortioxetine.

Reporting Groups
  Description
Placebo Placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 10 mg Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
Vortioxetine 20 mg Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.

Participant Flow:   Overall Study
    Placebo   Vortioxetine 10 mg   Vortioxetine 20 mg
STARTED   157   155   150 
Treated   157   155   150 
COMPLETED   139   124   122 
NOT COMPLETED   18   31   28 
Pretreatment Event or Adverse Event                2                9                7 
Lack of Efficacy                1                3                1 
Noncompliance with Study Drug                0                2                0 
Protocol Deviations                2                2                5 
Withdrawal of Consent                5                7                3 
Lost to Follow-up                7                7                10 
Other                1                1                2 



  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 Placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 10 mg Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
Vortioxetine 20 mg Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
Total Total of all reporting groups

Baseline Measures
   Placebo   Vortioxetine 10 mg   Vortioxetine 20 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 157   155   150   462 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.3  (11.61)   43.1  (12.04)   43.1  (13.09)   42.8  (12.23) 
Age, Customized 
[Units: Participants]
       
≤55 years   130   133   124   387 
>55 years   27   22   26   75 
Gender 
[Units: Participants]
       
Female   110   118   107   335 
Male   47   37   43   127 
Race/Ethnicity, Customized 
[Units: Participants]
       
Hispanic or Latino   17   10   10   37 
Non-Hispanic and non-Latino   140   145   140   425 
Race/Ethnicity, Customized 
[Units: Participants]
       
Caucasian (White, including Hispanic)   120   106   97   323 
Black   37   43   49   129 
American Indian or Alaska Native   0   4   1   5 
Asian   0   2   1   3 
Native Hawaiian or Other Pacific Islander   0   0   2   2 
Region of Enrollment 
[Units: Participants]
       
United States   157   155   150   462 
Height 
[Units: Cm]
Mean (Standard Deviation)
 167.46  (9.265)   166.86  (9.199)   167.92  (9.194)   167.41  (9.210) 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 88.28  (23.290)   89.00  (23.076)   87.08  (23.582)   88.13  (23.277) 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 31.31  (7.262)   31.92  (7.779)   30.84  (7.836)   31.36  (7.622) 
Waist Circumference 
[Units: Cm]
Mean (Standard Deviation)
 100.20  (18.640)   99.76  (16.996)   96.76  (16.434)   98.93  (17.426) 
Smoking Classification 
[Units: Participants]
       
Never smoked   65   82   77   224 
Current smoker   52   46   45   143 
Ex-smoker   40   27   28   95 
Alcohol Consumption 
[Units: Participants]
       
Never   54   63   52   169 
Once monthly or less often   63   47   65   175 
Once per week   22   21   19   62 
2-to-6 times per week   15   21   14   50 
Daily   3   3   0   6 
Montgomery Åsberg Depression Rating Scale (MADRS) total score [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 32.0  (3.99)   32.3  (4.52)   32.4  (4.30)   32.2  (4.27) 
[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)
 17.8  (5.41)   18.5  (5.25)   18.9  (5.64)   18.4  (5.44) 
[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).
Clinical Global Impression - Severity scale score [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 4.5  (0.55)   4.5  (0.55)   4.5  (0.54)   4.5  (0.55) 
[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.


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

4.  Secondary:   Change From Baseline in MADRS Total Score at Week 8 in Participants With Baseline Hamilton Anxiety Scale (HAM-A) Total Score ≥20   [ Time Frame: Baseline and Week 8 ]

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

6.  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

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

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

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01163266     History of Changes
Other Study ID Numbers: LuAA21004_316
U1111-1115-8770 ( Registry Identifier: WHO )
First Submitted: July 14, 2010
First Posted: July 15, 2010
Results First Submitted: October 25, 2013
Results First Posted: December 18, 2013
Last Update Posted: December 18, 2013