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An Efficacy and Safety Study of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder

This study has been completed.
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT00734071
First received: August 11, 2008
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, Investigator);   Primary Purpose: Treatment
Condition: Generalized Anxiety Disorder
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 33 investigative sites in the United States from 25 June 2008 to 06 March 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 generalized anxiety disorder were enrolled equally in one of two treatment groups, once a day placebo or 5 mg vortioxetine.

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

Participant Flow:   Overall Study
    Placebo   Vortioxetine 5 mg
STARTED   152   152 
Treated   151   148 
COMPLETED   114   125 
NOT COMPLETED   38   27 
Adverse Event                4                3 
Lack of Efficacy                3                1 
Noncompliance                2                2 
Protocol Deviations                3                4 
Voluntary Withdrawal                9                7 
Lost to Follow-up                16                8 
Other                1                2 



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

Baseline Measures
   Placebo   Vortioxetine 5 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 152   152   304 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.4  (12.81)   41.0  (14.05)   41.2  (13.42) 
Age, Customized 
[Units: Participants]
     
≤55 years   128   129   257 
>55 years   24   23   47 
Gender 
[Units: Participants]
     
Female   97   103   200 
Male   55   49   104 
Race/Ethnicity, Customized 
[Units: Participants]
     
Caucasian (White, including Hispanic)   131   123   254 
Black   17   24   41 
Asian   2   3   5 
American Indian or Alaska Native   0   2   2 
Native Hawaiian/ Other Pacific Islander   2   0   2 
Race/Ethnicity, Customized 
[Units: Participants]
     
Hispanic/Latino   24   26   50 
Non-Hispanic/Non-Latino   128   126   254 
Region of Enrollment 
[Units: Participants]
     
United States   152   152   304 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 83.68  (20.916)   80.10  (20.296)   81.89  (20.652) 
Height 
[Units: Cm]
Mean (Standard Deviation)
 167.73  (8.765)   167.72  (9.158)   167.73  (8.949) 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 29.66  (6.861)   28.42  (6.680)   29.04  (6.789) 
Smoking Classification 
[Units: Participants]
     
Never Smoked   78   76   154 
Current Smoker   38   43   81 
Ex-smoker   36   33   69 
Alcohol Consumption 
[Units: Participants]
     
Never   48   39   87 
Once monthly or less often   57   55   112 
Once a week   17   28   45 
2 to 6 times per week   27   27   54 
Daily   3   3   6 
Hamilton Anxiety Scale Total Score [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 24.6  (3.60)   24.7  (3.79)   24.7  (3.69) 
[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)
 4.3  (0.49)   4.3  (0.53)   4.3  (0.51) 
[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. The number of participants with available data were 151 and 152 in each treatment arm respectively.
Hospital Anxiety and Depression – Anxiety subscale [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 13.5  (3.14)   13.8  (3.39)   13.7  (3.26) 
[1] Hospital Anxiety and Depression (HAD) Anxiety sub-scale consists of 7 items that are assessed on a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). The anxiety subscale determines a state of generalized anxiety including anxious mood, restlessness, anxious thoughts and panic attacks. Scores are summed and range from 0 to 21 (maximal severity). The number of participants with available data were 149 and 151 in each treatment arm respectively.
Hospital Anxiety and Depression – Depression subscale [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 8.5  (3.79)   8.1  (3.91)   8.3  (3.85) 
[1] Hospital Anxiety and Depression (HAD) Depression sub-scale consists of 7 items that are assessed on a scale from 0 (no depression) to 3 (severe feeling of depression). The depression subscale focuses on the state of lost interest and diminished pleasure response. Scores are summed and range from 0 to 21 (maximal severity). The number of participants with available data were 149 and 151 in each treatment arm respectively.
Montgomery Åsberg Depression Rating Scale (MADRS) total score [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 11.83  (3.007)   12.09  (2.902)   11.96  (2.953) 
[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).


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8   [ Time Frame: Baseline to Week 8 ]

2.  Secondary:   Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale 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:   Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8   [ Time Frame: Baseline to Week 8 ]

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

6.  Secondary:   Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25   [ Time Frame: Baseline to Week 8 ]

7.  Secondary:   Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Week 8   [ Time Frame: Baseline to Week 8 ]

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

9.  Secondary:   Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Other Weeks Assessed   [ Time Frame: Baseline to Weeks 1 and 4 ]

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

11.  Secondary:   Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed   [ Time Frame: Baseline to Weeks 1, 2 and 4 ]

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

13.  Secondary:   Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25   [ Time Frame: Baseline to Weeks 1, 2, 4 and 6 ]

14.  Secondary:   Percentage of Participants in HAM-A Remission at Each Week Assessed   [ Time Frame: Weeks 1, 2, 4, 6 and 8 ]

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

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

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

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

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

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

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

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

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

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

25.  Secondary:   Health Care 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
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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
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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 of Results:

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00734071     History of Changes
Other Study ID Numbers: LuAA21004_310
U1111-1114-4876 ( Registry Identifier: WHO )
Study First Received: August 11, 2008
Results First Received: October 25, 2013
Last Updated: October 25, 2013
Health Authority: United States: Food and Drug Administration