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

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ClinicalTrials.gov Identifier: NCT01473381
Recruitment Status : Completed
First Posted : November 17, 2011
Results First Posted : August 8, 2014
Last Update Posted : August 8, 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: Vilazodone
Drug: Placebo to citalopram
Drug: Placebo to vilazodone
Drug: Citalopram
Enrollment 1162
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Vilazodone 20 mg/Day Vilazodone 40 mg/Day Citalopram 40 mg/Day
Hide Arm/Group Description Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. 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. 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. 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.
Period Title: Overall Study
Started 290 292 291 289
Safety Population 281 288 287 282
Completed 210 199 189 200
Not Completed 80 93 102 89
Reason Not Completed
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
Arm/Group Title Placebo Vilazodone 20 mg/Day Vilazodone 40 mg/Day Citalopram 40 mg/Day Total
Hide Arm/Group Description Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 281 288 287 282 1138
Hide Baseline Analysis Population Description
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 281 participants 288 participants 287 participants 282 participants 1138 participants
42.0  (13.0) 41.7  (12.7) 40.8  (13.2) 42.6  (12.6) 41.8  (12.8)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 281 participants 288 participants 287 participants 282 participants 1138 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
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 281 participants 288 participants 287 participants 282 participants 1138 participants
Female
158
  56.2%
166
  57.6%
164
  57.1%
165
  58.5%
653
  57.4%
Male
123
  43.8%
122
  42.4%
123
  42.9%
117
  41.5%
485
  42.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 281 participants 288 participants 287 participants 282 participants 1138 participants
Hispanic or Latino
59
  21.0%
55
  19.1%
43
  15.0%
53
  18.8%
210
  18.5%
Not Hispanic or Latino
222
  79.0%
233
  80.9%
244
  85.0%
229
  81.2%
928
  81.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 281 participants 288 participants 287 participants 282 participants 1138 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  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 281 participants 288 participants 287 participants 282 participants 1138 participants
82.27  (17.02) 82.55  (18.16) 82.45  (17.85) 82.37  (18.30) 82.41  (17.82)
Weight  
Median (Full Range)
Unit of measure:  Kg
Number Analyzed 281 participants 288 participants 287 participants 282 participants 1138 participants
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  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 281 participants 288 participants 287 participants 282 participants 1138 participants
169.03  (9.38) 168.86  (9.72) 169.87  (9.71) 169.78  (9.57) 169.39  (9.60)
Height  
Median (Full Range)
Unit of measure:  Cm
Number Analyzed 281 participants 288 participants 287 participants 282 participants 1138 participants
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)  
Mean (Standard Deviation)
Unit of measure:  Kilograms per meter squared
Number Analyzed 281 participants 288 participants 287 participants 282 participants 1138 participants
28.70  (5.40) 28.79  (5.49) 28.45  (5.43) 28.36  (5.17) 28.58  (5.37)
Body Mass Index (BMI)  
Median (Full Range)
Unit of measure:  Kilograms per meter squared
Number Analyzed 281 participants 288 participants 287 participants 282 participants 1138 participants
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)
1.Primary Outcome
Title Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 10
Hide Description The MADRS is a clinician-rated scale based on participant interviews. The scale assesses depressive symptomatology that occurred in participants during the week preceding each interview. Participants were rated on 10 items: Apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. 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 of the 10 items and ranged from 0 to 60. A higher score indicates more depressive symptomatology. A negative change score indicates improvement.
Time Frame Baseline to Week 10
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 placebo, vilazodone, or citalopram and who had a baseline and at least 1 post-baseline assessment of the MADRS total score.
Arm/Group Title Placebo Vilazodone 20 mg/Day Vilazodone 40 mg/Day Citalopram 40 mg/Day
Hide Arm/Group Description:
Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.
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.
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.
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.
Overall Number of Participants Analyzed 281 288 284 280
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-14.76  (0.62) -17.33  (0.63) -17.58  (0.65) -17.50  (0.64)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vilazodone 20 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0073
Comments P-value was adjusted for multiplicity.
Method Mixed-effect model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.57
Confidence Interval (2-Sided) 95%
-4.30 to -0.84
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Vilazodone 40 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0034
Comments P-value was adjusted for multiplicity.
Method Mixed-effect model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.82
Confidence Interval (2-Sided) 95%
-4.57 to -1.06
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Citalopram 40 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0020
Comments P-value was provided for assay sensitivity. It was not adjusted for multiplicity.
Method Mixed-effect model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.74
Confidence Interval (2-Sided) 95%
-4.48 to -1.00
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline to Week 10 in the Clinical Global Impressions-Severity (CGI-S) Scale Score
Hide Description The Clinical Global Impressions-Severity scale is a clinician-rated scale used to rate the severity of the participant’s current state of mental illness compared with a patient population with major depressive disorder. In particular, the clinician is asked to respond to the following question: “Considering your total clinical experience with this population, how mentally ill is the patient at this time?” The patient is rated on the following 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. A higher score indicates more mental illness. A negative change score indicates improvement.
Time Frame Baseline to Week 10
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 placebo, vilazodone, or citalopram and who had a baseline and at least 1 post-baseline assessment of the MADRS total score.
Arm/Group Title Placebo Vilazodone 20 mg/Day Vilazodone 40 mg/Day Citalopram 40 mg/Day
Hide Arm/Group Description:
Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.
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.
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.
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.
Overall Number of Participants Analyzed 281 288 284 280
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-1.53  (0.08) -1.88  (0.08) -1.86  (0.08) -1.88  (0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vilazodone 20 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0073
Comments P-value was adjusted for multiplicity.
Method Mixed-effect model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.35
Confidence Interval (2-Sided) 95%
-0.58 to -0.13
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Vilazodone 40 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0097
Comments P-value was adjusted for multiplicity.
Method Mixed-effect model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.33
Confidence Interval (2-Sided) 95%
-0.55 to -0.10
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Citalopram 40 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0025
Comments P-value was provided for assay sensitivity. It was not adjusted for multiplicity.
Method Mixed-effect model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.35
Confidence Interval (2-Sided) 95%
-0.57 to -0.12
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response
Hide Description The MADRS is a clinician-rated scale based on participant interviews. The scale assesses depressive symptomatology that occurred in participants during the week preceding each interview. Participants were rated on 10 items: Apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. 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 of the 10 items and ranged from 0 to 60. A higher score indicates more depressive symptomatology. A MADRS sustained response was defined as a MADRS total score ≤ 12 for at least the last 2 visits during the double-blind treatment period (Weeks 1-10). A total MADRS score ≤ 12 corresponds to an average score of 1 per item and is indicative of very low level of depressive symptoms.
Time Frame Baseline to Week 10
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 placebo, vilazodone, or citalopram and who had a baseline and at least 1 post-baseline assessment of the MADRS total score.
Arm/Group Title Placebo Vilazodone 20 mg/Day Vilazodone 40 mg/Day Citalopram 40 mg/Day
Hide Arm/Group Description:
Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.
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.
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
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.
Overall Number of Participants Analyzed 281 288 284 280
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
26.3
(21.2 to 31.5)
29.9
(24.6 to 35.1)
33.5
(28.0 to 38.9)
31.1
(25.7 to 36.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vilazodone 20 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3563
Comments P-value was adjusted for multiplicity.
Method Cochran-Mantel-Haenszel
Comments The Mean Difference (Final Values), as well as 95% Confidence Interval, are in units of percentage.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.5
Confidence Interval (2-Sided) 95%
-3.9 to 10.9
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Vilazodone 40 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1611
Comments P-value was adjusted for multiplicity.
Method Cochran-Mantel-Haenszel
Comments The Mean Difference (Final Values), as well as 95% Confidence Interval, are in units of percentage.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.1
Confidence Interval (2-Sided) 95%
-0.4 to 14.6
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Citalopram 40 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2672
Comments P-value was provided for assay sensitivity. It was not adjusted for multiplicity.
Method Cochran-Mantel-Haenszel
Comments The Mean Difference (Final Values), as well as 95% Confidence Interval, are in units of percentage.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.7
Confidence Interval (2-Sided) 95%
-2.7 to 12.2
Estimation Comments [Not Specified]
Time Frame From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Adverse Event Reporting Description Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
 
Arm/Group Title Placebo Vilazodone 20 mg/Day Vilazodone 40 mg/Day Citalopram 40 mg/Day
Hide Arm/Group Description Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. 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. 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. 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.
All-Cause Mortality
Placebo Vilazodone 20 mg/Day Vilazodone 40 mg/Day Citalopram 40 mg/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Vilazodone 20 mg/Day Vilazodone 40 mg/Day Citalopram 40 mg/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/281 (1.07%)   4/288 (1.39%)   4/287 (1.39%)   6/282 (2.13%) 
Blood and lymphatic system disorders         
Haemorrhagic anaemia  1  0/281 (0.00%)  0/288 (0.00%)  0/287 (0.00%)  1/282 (0.35%) 
Cardiac disorders         
Angina pectoris  1  1/281 (0.36%)  0/288 (0.00%)  0/287 (0.00%)  0/282 (0.00%) 
Cardiomegaly  1  0/281 (0.00%)  1/288 (0.35%)  0/287 (0.00%)  0/282 (0.00%) 
Gastrointestinal disorders         
Diverticulitis  1  0/281 (0.00%)  0/288 (0.00%)  1/287 (0.35%)  1/282 (0.35%) 
Gastric disorder  1  1/281 (0.36%)  0/288 (0.00%)  0/287 (0.00%)  0/282 (0.00%) 
Immune system disorders         
Asthma  1  0/281 (0.00%)  1/288 (0.35%)  0/287 (0.00%)  0/282 (0.00%) 
Infections and infestations         
Bronchitis  1  0/281 (0.00%)  1/288 (0.35%)  0/287 (0.00%)  0/282 (0.00%) 
Pneumonia  1  1/281 (0.36%)  0/288 (0.00%)  0/287 (0.00%)  0/282 (0.00%) 
Sepsis  1  0/281 (0.00%)  0/288 (0.00%)  1/287 (0.35%)  0/282 (0.00%) 
Abscess Neck  1  1/281 (0.36%)  0/288 (0.00%)  0/287 (0.00%)  0/282 (0.00%) 
Abscess Oral  1  1/281 (0.36%)  0/288 (0.00%)  0/287 (0.00%)  0/282 (0.00%) 
Injury, poisoning and procedural complications         
Accidental overdose  1  0/281 (0.00%)  1/288 (0.35%)  0/287 (0.00%)  0/282 (0.00%) 
Ilium fracture  1  0/281 (0.00%)  0/288 (0.00%)  0/287 (0.00%)  1/282 (0.35%) 
Intentional overdose  1  0/281 (0.00%)  0/288 (0.00%)  1/287 (0.35%)  0/282 (0.00%) 
Road traffic accident  1  0/281 (0.00%)  0/288 (0.00%)  0/287 (0.00%)  1/282 (0.35%) 
Traumatic renal injury  1  0/281 (0.00%)  0/288 (0.00%)  0/287 (0.00%)  1/282 (0.35%) 
Investigations         
Electrocardiogram ST segment abnormal  1  1/281 (0.36%)  0/288 (0.00%)  0/287 (0.00%)  0/282 (0.00%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  1/281 (0.36%)  0/288 (0.00%)  0/287 (0.00%)  0/282 (0.00%) 
Wrist fracture  1  0/281 (0.00%)  0/288 (0.00%)  0/287 (0.00%)  1/282 (0.35%) 
Nervous system disorders         
Dizziness  1  0/281 (0.00%)  1/288 (0.35%)  0/287 (0.00%)  0/282 (0.00%) 
Migraine with aura  1  0/281 (0.00%)  0/288 (0.00%)  0/287 (0.00%)  1/282 (0.35%) 
Pregnancy, puerperium and perinatal conditions         
Abortion missed  1  0/281 (0.00%)  0/288 (0.00%)  0/287 (0.00%)  1/282 (0.35%) 
Psychiatric disorders         
Bipolar I disorder  1  0/281 (0.00%)  0/288 (0.00%)  1/287 (0.35%)  0/282 (0.00%) 
Somnolence  1  0/281 (0.00%)  0/288 (0.00%)  1/287 (0.35%)  0/282 (0.00%) 
Suicidal ideation  1  1/281 (0.36%)  0/288 (0.00%)  0/287 (0.00%)  1/282 (0.35%) 
Suicide attempt  1  0/281 (0.00%)  0/288 (0.00%)  1/287 (0.35%)  0/282 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Pulmonary embolism  1  0/281 (0.00%)  1/288 (0.35%)  0/287 (0.00%)  0/282 (0.00%) 
Status asthmaticus  1  0/281 (0.00%)  1/288 (0.35%)  0/287 (0.00%)  0/282 (0.00%) 
Obstructive Airways Disorder  1  1/281 (0.36%)  0/288 (0.00%)  0/287 (0.00%)  0/282 (0.00%) 
Surgical and medical procedures         
Hospitalisation  1  0/281 (0.00%)  0/288 (0.00%)  0/287 (0.00%)  1/282 (0.35%) 
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%
Placebo Vilazodone 20 mg/Day Vilazodone 40 mg/Day Citalopram 40 mg/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   124/281 (44.13%)   168/288 (58.33%)   177/287 (61.67%)   147/282 (52.13%) 
Gastrointestinal disorders         
Diarrhoea  1  26/281 (9.25%)  75/288 (26.04%)  76/287 (26.48%)  30/282 (10.64%) 
Nausea  1  23/281 (8.19%)  62/288 (21.53%)  69/287 (24.04%)  55/282 (19.50%) 
Dry mouth  1  14/281 (4.98%)  22/288 (7.64%)  19/287 (6.62%)  18/282 (6.38%) 
Vomiting  1  7/281 (2.49%)  11/288 (3.82%)  19/287 (6.62%)  5/282 (1.77%) 
General disorders         
Fatigue  1  9/281 (3.20%)  11/288 (3.82%)  11/287 (3.83%)  20/282 (7.09%) 
Nervous system disorders         
Headache  1  39/281 (13.88%)  42/288 (14.58%)  41/287 (14.29%)  42/282 (14.89%) 
Dizziness  1  20/281 (7.12%)  18/288 (6.25%)  18/287 (6.27%)  19/282 (6.74%) 
Psychiatric disorders         
Somnolence  1  10/281 (3.56%)  11/288 (3.82%)  18/287 (6.27%)  22/282 (7.80%) 
Insomnia  1  8/281 (2.85%)  19/288 (6.60%)  16/287 (5.57%)  12/282 (4.26%) 
Respiratory, thoracic and mediastinal disorders         
Upper respiratory tract infection  1  13/281 (4.63%)  14/288 (4.86%)  15/287 (5.23%)  14/282 (4.96%) 
Nasopharyngitis  1  11/281 (3.91%)  12/288 (4.17%)  13/287 (4.53%)  15/282 (5.32%) 
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: Suresh Durgam, MD Clinical Asset Lead for Vilazodone - Senior Director – Clinical Development
Organization: Forest Research Institute
Phone: 201 427-8000 ext 8172
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01473381     History of Changes
Other Study ID Numbers: VLZ-MD-01
First Submitted: November 14, 2011
First Posted: November 17, 2011
Results First Submitted: June 13, 2014
Results First Posted: August 8, 2014
Last Update Posted: August 8, 2014