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Safety and Efficacy of Vilazodone in Major Depressive Disorder (VLZ-MD-01)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01473381
First received: November 14, 2011
Last updated: August 6, 2014
Last verified: August 2014
Results First Received: June 13, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Interventions: Drug: Vilazodone
Drug: Placebo to citalopram
Drug: Placebo to vilazodone
Drug: Citalopram

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.
Vilazodone 20 mg/Day Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11.
Vilazodone 40 mg/Day Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days.
Citalopram 40 mg/Day Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11.

Participant Flow:   Overall Study
    Placebo   Vilazodone 20 mg/Day   Vilazodone 40 mg/Day   Citalopram 40 mg/Day
STARTED   290   292   291   289 
Safety Population   281   288   287   282 
COMPLETED   210   199   189   200 
NOT COMPLETED   80   93   102   89 
Adverse Event                8                20                25                17 
Insufficient Therapeutic Response                10                1                2                3 
Protocol Violation                17                23                19                17 
Withdrawal of Consent                20                21                20                26 
Lost to Follow-up                25                28                35                23 
Other Reasons                0                0                1                3 



  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.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).

Reporting Groups
  Description
Placebo Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.
Vilazodone 20 mg/Day Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11.
Vilazodone 40 mg/Day Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days.
Citalopram 40 mg/Day Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11.
Total Total of all reporting groups

Baseline Measures
   Placebo   Vilazodone 20 mg/Day   Vilazodone 40 mg/Day   Citalopram 40 mg/Day   Total 
Overall Participants Analyzed 
[Units: Participants]
 281   288   287   282   1138 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.0  (13.0)   41.7  (12.7)   40.8  (13.2)   42.6  (12.6)   41.8  (12.8) 
Age, Customized 
[Units: Participants]
         
< 20 years   5   2   9   2   18 
≥ 20-29 years   63   62   63   53   241 
≥ 30-39 years   48   59   68   59   234 
≥ 40-49 years   73   88   62   76   299 
≥ 50-59 years   66   50   62   66   244 
≥ 60 years   26   27   23   26   102 
Gender 
[Units: Participants]
         
Female   158   166   164   165   653 
Male   123   122   123   117   485 
Ethnicity (NIH/OMB) 
[Units: Participants]
         
Hispanic or Latino   59   55   43   53   210 
Not Hispanic or Latino   222   233   244   229   928 
Unknown or Not Reported   0   0   0   0   0 
Race/Ethnicity, Customized 
[Units: Participants]
         
White   197   205   202   184   788 
Black or African American   71   73   74   83   301 
Asian   7   7   3   3   20 
American Indian or Alaska Native   3   0   2   4   9 
Native Hawaiian or Other Pacific Islander   0   1   2   1   4 
Other   3   2   4   7   16 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 82.27  (17.02)   82.55  (18.16)   82.45  (17.85)   82.37  (18.30)   82.41  (17.82) 
Weight 
[Units: Kg]
Median (Full Range)
 82.50 
 (46.5 to 127.1) 
 82.40 
 (45.0 to 137.9) 
 82.10 
 (48.8 to 132.9) 
 79.50 
 (46.6 to 151.6) 
 81.60 
 (45.0 to 151.6) 
Height 
[Units: Cm]
Mean (Standard Deviation)
 169.03  (9.38)   168.86  (9.72)   169.87  (9.71)   169.78  (9.57)   169.39  (9.60) 
Height 
[Units: Cm]
Median (Full Range)
 167.60 
 (144.8 to 198.1) 
 167.60 
 (147.3 to 195.6) 
 168.90 
 (146.0 to 193.0) 
 169.00 
 (144.8 to 200.7) 
 168.50 
 (144.8 to 200.7) 
Body Mass Index (BMI) 
[Units: Kilograms per meter squared]
Mean (Standard Deviation)
 28.70  (5.40)   28.79  (5.49)   28.45  (5.43)   28.36  (5.17)   28.58  (5.37) 
Body Mass Index (BMI) 
[Units: Kilograms per meter squared]
Median (Full Range)
 28.30 
 (18.5 to 40.0) 
 28.20 
 (18.4 to 39.6) 
 27.80 
 (18.3 to 40.0) 
 27.90 
 (18.0 to 39.9) 
 28.10 
 (18.0 to 40.0) 


  Outcome Measures
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1.  Primary:   Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 10   [ Time Frame: Baseline to Week 10 ]

2.  Secondary:   Change From Baseline to Week 10 in the Clinical Global Impressions-Severity (CGI-S) Scale Score   [ Time Frame: Baseline to Week 10 ]

3.  Secondary:   Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response   [ Time Frame: Baseline to Week 10 ]


  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: Suresh Durgam, MD Clinical Asset Lead for Vilazodone - Senior Director – Clinical Development
Organization: Forest Research Institute
phone: 201 427-8000 ext 8172
e-mail: suresh.durgam@frx.com


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

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01473381     History of Changes
Other Study ID Numbers: VLZ-MD-01
Study First Received: November 14, 2011
Results First Received: June 13, 2014
Last Updated: August 6, 2014
Health Authority: United States: Food and Drug Administration