Vortioxetine (Lu AA21004) 10 and 20 mg for Treatment of Major Depressive Disorder With Sexual Dysfunction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01364649
First received: May 31, 2011
Last updated: October 6, 2014
Last verified: October 2014
Results First Received: October 6, 2014  
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: Treatment Outcome
Interventions: Drug: Vortioxetine
Drug: Escitalopram
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 57 sites in the US and 9 sites in Canada from 16 June 12011 to 9 December 2013.

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 2 (flexible doses of either vortioxetine (Lu AA21004) 10/20 mg once daily (QD) or escitalopram 10/20 mg QD) treatment groups.

Reporting Groups
  Description
Vortioxetine Vortioxetine 10 mg, tablets, orally, once daily for 1 week, then dose adjustment to a maximum 20 mg tablets, orally, once daily for up to 7 weeks. At week 8, vortioxetine placebo-matching capsules, orally, once daily for 1 week only.
Escitalopram Escitalopram 10 mg, tablets, orally, once daily for 1 week, then escitalopram dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks. At week 8, escitalopram 10 mg, capsules, capsules, orally, once daily for 1 week only

Participant Flow:   Overall Study
    Vortioxetine     Escitalopram  
STARTED     225     222  
COMPLETED     169     179  
NOT COMPLETED     56     43  
Pretreatment Event or Adverse Event                 20                 14  
Lack of Efficacy                 6                 0  
Non-compliance with Investigational Drug                 1                 0  
Protocol Deviations                 4                 8  
Withdrawal of Consent                 9                 7  
Lost to Follow-up                 12                 13  
Other                 4                 1  



  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.
All randomized set (N=447): All study participants who were screened and randomized to one of two treatment arms.

Reporting Groups
  Description
Vortioxetine Vortioxetine 10 mg, tablets, orally, once daily for 1 week, then dose adjustment to a maximum 20 mg tablets, orally, once daily for up to 7 weeks. At week 8, vortioxetine placebo-matching capsules, orally, once daily for 1 week only.
Escitalopram Escitalopram 10 mg, tablets, orally, once daily for 1 week, then escitalopram dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks. At week 8, escitalopram 10 mg, capsules, capsules, orally, once daily for 1 week only
Total Total of all reporting groups

Baseline Measures
    Vortioxetine     Escitalopram     Total  
Number of Participants  
[units: participants]
  225     222     447  
Age  
[units: years]
Mean ± Standard Deviation
  39.3  ± 9.96     40.2  ± 10.01     39.8  ± 9.98  
Age, Customized  
[units: participants]
     
≤41 years     122     112     234  
>41 years     103     110     213  
Gender  
[units: participants]
     
Female     128     135     263  
Male     97     87     184  
Race/Ethnicity, Customized  
[units: participants]
     
Hispanic or Latino     14     36     50  
Non-Hispanic and Non-Latino     211     186     397  
Race/Ethnicity, Customized  
[units: participants]
     
Caucasian (or White, including Hispanic)     178     181     359  
Black of African American     41     35     76  
Asian     4     3     7  
American Indian or Alaska Native     1     3     4  
Native Hawaiian or Other Pacific Islander     1     0     1  
Region of Enrollment  
[units: participants]
     
North America     225     222     447  
Study-Specific Measure  
[units: cm]
Mean ± Standard Deviation
  169.6  ± 9.73     170.3  ± 8.81     169.9  ± 9.28  
Study-Specific Measure  
[units: kg]
Mean ± Standard Deviation
  79.62  ± 16.202     81.22  ± 16.012     80.41  ± 16.110  
Study-Specific Measure  
[units: kg/m^2]
Mean ± Standard Deviation
  27.54  ± 4.352     27.90  ± 4.440     27.72  ± 4.395  
Study-Specific Measure  
[units: cm]
Mean ± Standard Deviation
  90.85  ± 13.274     93.31  ± 13.074     92.07  ± 13.218  
Study-Specific Measure  
[units: participants]
     
Never smoked     112     126     238  
Current smoker     69     55     124  
Ex-smoker     44     41     85  
Study-Specific Measure  
[units: participants]
     
Never     65     65     130  
Once monthly or less often     86     82     168  
Once a week     40     37     77  
2 to 6 times per week     33     36     69  
Daily     1     2     3  
Study-Specific Measure [1]
[units: scores on a scale]
Mean ± Standard Deviation
  36.5  ± 5.81     36.3  ± 5.62     36.4  ± 5.71  
Study-Specific Measure [2]
[units: scores on a scale]
Mean ± Standard Deviation
  7.9  ± 6.28     8.3  ± 6.53     8.1  ± 6.40  
Study-Specific Measure [3]
[units: scores on a scale]
Mean ± Standard Deviation
  2.0  ± 0.81     2.0  ± 0.84     2.0  ± 0.82  
Study-Specific Measure [4]
[units: scores on a scale]
Mean ± Standard Deviation
  18.8  ± 19.36     19.7  ± 19.45     19.2  ± 19.39  
[1] The CSFQ-14 is a structured self reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), and orgasm (3 items), rated on an 5 point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. The number of participants with available data were 220 and 216 in each treatment arm respectively.
[2] 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). The number of participants with available data were 224 and 221 in each treatment arm respectively.
[3] 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 224 and 221 in each treatment arm respectively.
[4] POMS brief is a rating scale, which comprises of 30 items that are evaluated in a 0-4 scale (0=not at all and 4=extremely). The scores for the 30 items are added in various combinations to throw six validated factors which are used to calculate total POMS score: (tension-anxiety) + (depression-dejection) + (anger-hostility)+ (fatigue-Inertia) + (confusion-bewilderment) - (vigor-activity). Score range (-40 to 192). Score -40 denotes the best score and score 192 denotes the worst score. The number of participants with available data were 224 and 219 in each treatment arm respectively.



  Outcome Measures
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1.  Primary:   Change From Baseline in the Changes in Sexual Functioning Questionnaire Short-Form (CSFQ-14) Total Score at Week 8   [ Time Frame: Baseline, Week 8 ]

2.  Secondary:   Change From Baseline in the CSFQ-14 Total Score at All Other Time Points Assessed   [ Time Frame: Baseline and Weeks 1, 2, 4 and 6 ]

3.  Secondary:   Number of Participants With Shifts in the CSFQ-14 From Abnormal to Normal at Each Week Assessed   [ Time Frame: Baseline and Weeks 1, 2, 4, 6 and 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
Organization: Takeda
phone: +1-877-825-3327
e-mail: clinicaltrialregistry@tpna.com


No publications provided


Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01364649     History of Changes
Other Study ID Numbers: LuAA21004_318, U1111-1120-3483
Study First Received: May 31, 2011
Results First Received: October 6, 2014
Last Updated: October 6, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada