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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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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  
Number of Participants  
[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
  Show All Outcome Measures

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


No publications provided


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