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Randomized, Double-Blind, Placebo Controlled Study of Vilazodone's Efficacy, Safety, and Biomarkers of Response in Major Depressive Disorder (MDD)

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ClinicalTrials.gov Identifier: NCT00683592
Recruitment Status : Completed
First Posted : May 23, 2008
Results First Posted : October 27, 2010
Last Update Posted : October 27, 2010
Sponsor:
Information provided by:
Forest Laboratories

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Interventions: Drug: vilazodone
Drug: placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period was 31Mar2008 to 10Feb2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This study included a washout period to allow patients to discontinue their current antidepressant medications and any additional medications prohibited by the protocol, if applicable.

Reporting Groups
  Description
Vilazodone Vilazodone titrated to 40mg. Two tablets per day.
Placebo Placebo to match vilazodone. Two tablets per day.

Participant Flow:   Overall Study
    Vilazodone   Placebo
STARTED   240   241 
Intent to Treat Population   231   232 
Safety Population   235   233 
COMPLETED   193   195 
NOT COMPLETED   47   46 
Adverse Event                12                4 
Withdrawal by Subject                11                11 
Lost to Follow-up                17                17 
Lack of Efficacy                3                7 
Physician Decision                0                1 
Non-compliance                3                5 
Other                1                1 



  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.
No text entered.

Reporting Groups
  Description
Vilazodone (ITT Population) Vilazodone, 40 mg
Placebo (ITT Population) placebo to match vilazodone
Total Total of all reporting groups

Baseline Measures
   Vilazodone (ITT Population)   Placebo (ITT Population)   Total 
Overall Participants Analyzed 
[Units: Participants]
 231   232   463 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.1  (12.22)   42.4  (12.49)   41.7  (12.36) 
Gender 
[Units: Participants]
     
Female   138   123   261 
Male   93   109   202 
Region of Enrollment 
[Units: Participants]
     
United States   231   232   463 


  Outcome Measures

1.  Primary:   Change From Baseline to Week 8 in the MADRS (Montgomery-Asberg Depression Rating Scale) Total Score.   [ Time Frame: Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 ]

2.  Secondary:   Change From Baseline to Week 8 in the HAM-D 17 (17-Item Hamilton Rating Scale for Depression) Total Score   [ Time Frame: Baseline, week 1, week 2, week 4, week 6, week 8 ]

3.  Secondary:   The CGI-I (Clinician's Global Impression of Improvement) Score at Week 8   [ Time Frame: Week 1, Week 2, Week 4, Week 6, Week 8 ]

4.  Secondary:   Change From Baseline to Week 8 in the HAM-A ( Hamilton Anxiety Rating Scale) Total Score   [ Time Frame: Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 ]

5.  Secondary:   MADRS (Montgomery-Asberg Depression Rating Scale) Response Rate at Week 8   [ Time Frame: Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 ]

6.  Secondary:   MADRS (Montgomery-Asberg Depression Rating Scale) Remission Rate at Week 8   [ Time Frame: Baseline, Week 1, Week 2, Week 4, Week 6, 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: Director of Medical Affairs
Organization: PGxHealth, LLC
phone: 203-786-3400


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

Responsible Party: Carol R. Reed, MD, PGxHealth, LLC
ClinicalTrials.gov Identifier: NCT00683592     History of Changes
Other Study ID Numbers: CLDA-07-DP-02
First Submitted: May 21, 2008
First Posted: May 23, 2008
Results First Submitted: July 19, 2010
Results First Posted: October 27, 2010
Last Update Posted: October 27, 2010