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Safety, Efficacy, and Tolerability of Vilazodone in Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT01473394
Recruitment Status : Completed
First Posted : November 17, 2011
Results First Posted : April 3, 2014
Last Update Posted : April 3, 2014
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Interventions: Drug: Dose-matched placebo
Drug: Vilazodone

  Participant Flow

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
Dose-matched Placebo Participants received dose-matched placebo orally once daily for 9 weeks.
Vilazodone Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.

Participant Flow:   Overall Study
    Dose-matched Placebo   Vilazodone
STARTED   253   255 
COMPLETED   208   212 
NOT COMPLETED   45   43 
Adverse Event                13                16 
Insufficient Therapeutic Response                4                1 
Protocol Violation                7                5 
Withdrew Consent                12                10 
Lost to Follow-up                9                11 



  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.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product.

Reporting Groups
  Description
Dose-matched Placebo Participants received dose-matched placebo orally once daily for 9 weeks.
Vilazodone Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
Total Total of all reporting groups

Baseline Measures
   Dose-matched Placebo   Vilazodone   Total 
Overall Participants Analyzed 
[Units: Participants]
 253   255   508 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.1  (13.2)   39.3  (12.8)   40.2  (13.0) 
Age, Customized 
[Units: Participants]
     
< 20   7   6   13 
≥ 20-29   53   68   121 
≥ 30-39   54   56   110 
≥ 40-49   67   62   129 
≥ 50-59   48   44   92 
≥ 60   24   19   43 
Gender 
[Units: Participants]
     
Female   142   131   273 
Male   111   124   235 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   33   42   75 
Not Hispanic or Latino   220   213   433 
Unknown or Not Reported   0   0   0 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   168   174   342 
Black or African American   70   52   122 
Asian   7   14   21 
American Indian or Alaska Native   0   4   4 
Native Hawaiian or Other Pacific Islander   1   0   1 
Other   7   11   18 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 84.68  (17.84)   82.89  (18.39)   83.78  (18.12) 
Height 
[Units: Cm]
Mean (Standard Deviation)
 170.15  (9.12)   170.32  (9.60)   170.23  (9.36) 
Body mass index 
[Units: Kg/m^2]
Mean (Standard Deviation)
 29.08  (5.50)   28.41  (5.47)   28.75  (5.49) 


  Outcome Measures

1.  Primary:   Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 8   [ Time Frame: Baseline to Week 8 ]

2.  Secondary:   Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score at Week 8   [ Time Frame: Baseline to Week 8 ]

3.  Secondary:   Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response Rate   [ Time Frame: Baseline to 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: Carl Gommoll
Organization: Forest Research Institute, Inc.
phone: 201 427-8000


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

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01473394     History of Changes
Other Study ID Numbers: VLZ-MD-03
First Submitted: November 14, 2011
First Posted: November 17, 2011
Results First Submitted: February 21, 2014
Results First Posted: April 3, 2014
Last Update Posted: April 3, 2014