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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
Enrollment 518
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dose-matched Placebo Vilazodone
Hide Arm/Group Description Participants received dose-matched placebo orally once daily for 9 weeks. 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.
Period Title: Overall Study
Started 253 255
Completed 208 212
Not Completed 45 43
Reason Not Completed
Adverse Event             13             16
Insufficient Therapeutic Response             4             1
Protocol Violation             7             5
Withdrew Consent             12             10
Lost to Follow-up             9             11
Arm/Group Title Dose-matched Placebo Vilazodone Total
Hide Arm/Group Description Participants received dose-matched placebo orally once daily for 9 weeks. 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 of all reporting groups
Overall Number of Baseline Participants 253 255 508
Hide Baseline Analysis Population Description
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 253 participants 255 participants 508 participants
41.1  (13.2) 39.3  (12.8) 40.2  (13.0)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 253 participants 255 participants 508 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
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 253 participants 255 participants 508 participants
Female
142
  56.1%
131
  51.4%
273
  53.7%
Male
111
  43.9%
124
  48.6%
235
  46.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 253 participants 255 participants 508 participants
Hispanic or Latino
33
  13.0%
42
  16.5%
75
  14.8%
Not Hispanic or Latino
220
  87.0%
213
  83.5%
433
  85.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 253 participants 255 participants 508 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  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 253 participants 255 participants 508 participants
84.68  (17.84) 82.89  (18.39) 83.78  (18.12)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 253 participants 255 participants 508 participants
170.15  (9.12) 170.32  (9.60) 170.23  (9.36)
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 253 participants 255 participants 508 participants
29.08  (5.50) 28.41  (5.47) 28.75  (5.49)
1.Primary Outcome
Title Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 8
Hide Description The MADRS is a clinician-rated scale for assessing depressive symptomatology that had occurred in participants during the week preceding each interview. Patients were rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores on the 10 items and ranged from 0 to 60. A higher score indicated more depressive symptomatology. A negative change score indicated improvement.
Time Frame Baseline to Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized participants who received at least 1 dose of double-blind investigational product and who had a Baseline and at least 1 post-baseline assessment of the MADRS total score.
Arm/Group Title Dose-matched Placebo Vilazodone
Hide Arm/Group Description:
Participants received dose-matched placebo orally once daily for 9 weeks.
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.
Overall Number of Participants Analyzed 252 253
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-11.0  (0.65) -16.1  (0.64)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dose-matched Placebo, Vilazodone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.00001
Comments [Not Specified]
Method Mixed-effects model for repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -5.117
Confidence Interval (2-Sided) 95%
-6.886 to -3.347
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score at Week 8
Hide Description The CGI-S is a clinician-rated scale for assessing the severity of the participant’s current state of mental illness compared with a patient population with major depressive disorder. The clinician responded to the following question “Considering your total clinical experience with this population, how mentally ill is the participant at this time?” on a 7-point scale: 1=normal, not at all ill; 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The scale ranges from 1 to 7. A higher score indicates more severe mental illness. A negative change score indicates improvement.
Time Frame Baseline to Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized participants who received at least 1 dose of double-blind investigational product and who had a Baseline and at least 1 post-baseline assessment of the MADRS total score.
Arm/Group Title Dose-matched Placebo Vilazodone
Hide Arm/Group Description:
Participants received dose-matched placebo orally once daily for 9 weeks.
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.
Overall Number of Participants Analyzed 252 253
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-1.2  (0.08) -1.8  (0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dose-matched Placebo, Vilazodone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.00001
Comments [Not Specified]
Method Mixed-effects model for repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -0.622
Confidence Interval (2-Sided) 95%
-0.845 to -0.399
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response Rate
Hide Description The MADRS Sustained response rate is defined as a MÅDRS total score ≤ 12 for at least the last 2 consecutive visits during the double-blind treatment period.
Time Frame Baseline to Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized participants who received at least 1 dose of double-blind investigational product and who had a Baseline and at least 1 post-baseline assessment of the MADRS total score.
Arm/Group Title Dose-matched Placebo Vilazodone
Hide Arm/Group Description:
Participants received dose-matched placebo orally once daily for 9 weeks.
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.
Overall Number of Participants Analyzed 252 253
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
17.1
(12.4 to 21.7)
27.3
(21.8 to 32.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dose-matched Placebo, Vilazodone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0047
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 10.2
Confidence Interval (2-Sided) 95%
3.0 to 17.4
Estimation Comments The Mean Difference (Final Values), as well as the 95% Confidence Interval, are in units of percentage.
Time Frame Adverse events were reported from the time the participant signs the informed consent form until 30 days after the last dose of treatment (up to 13 weeks).
Adverse Event Reporting Description Safety population: All randomized participants who received at least 1 dose of double-blind investigational product. The Severe Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
 
Arm/Group Title Dose-matched Placebo Vilazodone
Hide Arm/Group Description Participants received dose-matched placebo orally once daily for 9 weeks. 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.
All-Cause Mortality
Dose-matched Placebo Vilazodone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dose-matched Placebo Vilazodone
Affected / at Risk (%) Affected / at Risk (%)
Total   2/253 (0.79%)   3/255 (1.18%) 
Cardiac disorders     
Myocardial infarction  1  0/253 (0.00%)  1/255 (0.39%) 
General disorders     
Non-cardiac chest pain  1  0/253 (0.00%)  1/255 (0.39%) 
Injury, poisoning and procedural complications     
Intentional overdose  1  1/253 (0.40%)  0/255 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer  1  1/253 (0.40%)  0/255 (0.00%) 
Psychiatric disorders     
Suicidal ideation  1  0/253 (0.00%)  1/255 (0.39%) 
Suicide attempt  1  1/253 (0.40%)  0/255 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dose-matched Placebo Vilazodone
Affected / at Risk (%) Affected / at Risk (%)
Total   78/253 (30.83%)   149/255 (58.43%) 
Gastrointestinal disorders     
Diarrhoea  1  26/253 (10.28%)  83/255 (32.55%) 
Nausea  1  21/253 (8.30%)  63/255 (24.71%) 
Infections and infestations     
Upper respiratory tract infection  1  14/253 (5.53%)  10/255 (3.92%) 
Nervous system disorders     
Headache  1  26/253 (10.28%)  24/255 (9.41%) 
Dizziness  1  7/253 (2.77%)  18/255 (7.06%) 
Psychiatric disorders     
Insomnia  1  3/253 (1.19%)  15/255 (5.88%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.1)
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.

All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study.

Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc.

Results Point of Contact
Name/Title: Carl Gommoll
Organization: Forest Research Institute, Inc.
Phone: 201 427-8000
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