Trial Outcomes & Findings for Safety and Efficacy of Vilazodone in Major Depressive Disorder (NCT NCT01473381)
NCT ID: NCT01473381
Last Updated: 2014-08-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1162 participants
Primary outcome timeframe
Baseline to Week 10
Results posted on
2014-08-08
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
290
|
292
|
291
|
289
|
|
Overall Study
Safety Population
|
281
|
288
|
287
|
282
|
|
Overall Study
COMPLETED
|
210
|
199
|
189
|
200
|
|
Overall Study
NOT COMPLETED
|
80
|
93
|
102
|
89
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
8
|
20
|
25
|
17
|
|
Overall Study
Insufficient Therapeutic Response
|
10
|
1
|
2
|
3
|
|
Overall Study
Protocol Violation
|
17
|
23
|
19
|
17
|
|
Overall Study
Withdrawal of Consent
|
20
|
21
|
20
|
26
|
|
Overall Study
Lost to Follow-up
|
25
|
28
|
35
|
23
|
|
Overall Study
Other Reasons
|
0
|
0
|
1
|
3
|
Baseline Characteristics
Safety and Efficacy of Vilazodone in Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
Placebo
n=281 Participants
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
n=288 Participants
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
n=287 Participants
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
n=282 Participants
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
n=1138 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
42.0 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
41.7 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
40.8 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
42.6 years
STANDARD_DEVIATION 12.6 • n=4 Participants
|
41.8 years
STANDARD_DEVIATION 12.8 • n=21 Participants
|
|
Age, Customized
< 20 years
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
9 participants
n=5 Participants
|
2 participants
n=4 Participants
|
18 participants
n=21 Participants
|
|
Age, Customized
≥ 20-29 years
|
63 participants
n=5 Participants
|
62 participants
n=7 Participants
|
63 participants
n=5 Participants
|
53 participants
n=4 Participants
|
241 participants
n=21 Participants
|
|
Age, Customized
≥ 30-39 years
|
48 participants
n=5 Participants
|
59 participants
n=7 Participants
|
68 participants
n=5 Participants
|
59 participants
n=4 Participants
|
234 participants
n=21 Participants
|
|
Age, Customized
≥ 40-49 years
|
73 participants
n=5 Participants
|
88 participants
n=7 Participants
|
62 participants
n=5 Participants
|
76 participants
n=4 Participants
|
299 participants
n=21 Participants
|
|
Age, Customized
≥ 50-59 years
|
66 participants
n=5 Participants
|
50 participants
n=7 Participants
|
62 participants
n=5 Participants
|
66 participants
n=4 Participants
|
244 participants
n=21 Participants
|
|
Age, Customized
≥ 60 years
|
26 participants
n=5 Participants
|
27 participants
n=7 Participants
|
23 participants
n=5 Participants
|
26 participants
n=4 Participants
|
102 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
158 Participants
n=5 Participants
|
166 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
165 Participants
n=4 Participants
|
653 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
123 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
117 Participants
n=4 Participants
|
485 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
59 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
210 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
222 Participants
n=5 Participants
|
233 Participants
n=7 Participants
|
244 Participants
n=5 Participants
|
229 Participants
n=4 Participants
|
928 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
197 participants
n=5 Participants
|
205 participants
n=7 Participants
|
202 participants
n=5 Participants
|
184 participants
n=4 Participants
|
788 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
71 participants
n=5 Participants
|
73 participants
n=7 Participants
|
74 participants
n=5 Participants
|
83 participants
n=4 Participants
|
301 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
20 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
9 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
4 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
7 participants
n=4 Participants
|
16 participants
n=21 Participants
|
|
Weight
|
82.50 kg
n=5 Participants
|
82.40 kg
n=7 Participants
|
82.10 kg
n=5 Participants
|
79.50 kg
n=4 Participants
|
81.60 kg
n=21 Participants
|
|
Height
|
167.60 cm
n=5 Participants
|
167.60 cm
n=7 Participants
|
168.90 cm
n=5 Participants
|
169.00 cm
n=4 Participants
|
168.50 cm
n=21 Participants
|
|
Body Mass Index (BMI)
|
28.30 kilograms per meter squared
n=5 Participants
|
28.20 kilograms per meter squared
n=7 Participants
|
27.80 kilograms per meter squared
n=5 Participants
|
27.90 kilograms per meter squared
n=4 Participants
|
28.10 kilograms per meter squared
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 10Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=281 Participants
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
n=288 Participants
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
n=284 Participants
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
n=280 Participants
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.
|
|---|---|---|---|---|
|
Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 10
|
-14.76 Units on a scale
Standard Error 0.62
|
-17.33 Units on a scale
Standard Error 0.63
|
-17.58 Units on a scale
Standard Error 0.65
|
-17.50 Units on a scale
Standard Error 0.64
|
SECONDARY outcome
Timeframe: Baseline to Week 10Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=281 Participants
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
n=288 Participants
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
n=284 Participants
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
n=280 Participants
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.
|
|---|---|---|---|---|
|
Change From Baseline to Week 10 in the Clinical Global Impressions-Severity (CGI-S) Scale Score
|
-1.53 Units on a scale
Standard Error 0.08
|
-1.88 Units on a scale
Standard Error 0.08
|
-1.86 Units on a scale
Standard Error 0.08
|
-1.88 Units on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Baseline to Week 10Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=281 Participants
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
n=288 Participants
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
n=284 Participants
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
n=280 Participants
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.
|
|---|---|---|---|---|
|
Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response
|
26.3 Percentage of participants
Interval 21.2 to 31.5
|
29.9 Percentage of participants
Interval 24.6 to 35.1
|
33.5 Percentage of participants
Interval 28.0 to 38.9
|
31.1 Percentage of participants
Interval 25.7 to 36.5
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 124 other events
Deaths: 0 deaths
Vilazodone 20 mg/Day
Serious events: 4 serious events
Other events: 168 other events
Deaths: 0 deaths
Vilazodone 40 mg/Day
Serious events: 4 serious events
Other events: 177 other events
Deaths: 0 deaths
Citalopram 40 mg/Day
Serious events: 6 serious events
Other events: 147 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=281 participants at risk
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
n=288 participants at risk
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
n=287 participants at risk
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
n=282 participants at risk
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.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.35%
1/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.00%
0/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.35%
1/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.35%
1/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
Cardiac disorders
Angina pectoris
|
0.36%
1/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
Immune system disorders
Asthma
|
0.00%
0/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.35%
1/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.36%
1/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
Psychiatric disorders
Bipolar I disorder
|
0.00%
0/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.35%
1/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.35%
1/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.35%
1/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.35%
1/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.35%
1/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.35%
1/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
Investigations
Electrocardiogram ST segment abnormal
|
0.36%
1/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
Gastrointestinal disorders
Gastric disorder
|
0.36%
1/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
Surgical and medical procedures
Hospitalisation
|
0.00%
0/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.35%
1/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
Injury, poisoning and procedural complications
Ilium fracture
|
0.00%
0/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.35%
1/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.35%
1/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
Nervous system disorders
Migraine with aura
|
0.00%
0/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.35%
1/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
Infections and infestations
Pneumonia
|
0.36%
1/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.35%
1/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.35%
1/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
Infections and infestations
Sepsis
|
0.00%
0/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.35%
1/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
Psychiatric disorders
Somnolence
|
0.00%
0/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.35%
1/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.00%
0/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.35%
1/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
Psychiatric disorders
Suicidal ideation
|
0.36%
1/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.35%
1/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.35%
1/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
Injury, poisoning and procedural complications
Traumatic renal injury
|
0.00%
0/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.35%
1/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
Musculoskeletal and connective tissue disorders
Wrist fracture
|
0.00%
0/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.35%
1/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
Infections and infestations
Abscess Neck
|
0.36%
1/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
Infections and infestations
Abscess Oral
|
0.36%
1/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive Airways Disorder
|
0.36%
1/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
0.00%
0/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
Other adverse events
| Measure |
Placebo
n=281 participants at risk
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
n=288 participants at risk
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
n=287 participants at risk
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
n=282 participants at risk
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.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
9.3%
26/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
26.0%
75/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
26.5%
76/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
10.6%
30/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
Gastrointestinal disorders
Nausea
|
8.2%
23/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
21.5%
62/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
24.0%
69/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
19.5%
55/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
Nervous system disorders
Headache
|
13.9%
39/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
14.6%
42/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
14.3%
41/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
14.9%
42/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
Gastrointestinal disorders
Dry mouth
|
5.0%
14/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
7.6%
22/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
6.6%
19/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
6.4%
18/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
7/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
3.8%
11/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
6.6%
19/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
1.8%
5/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
Nervous system disorders
Dizziness
|
7.1%
20/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
6.2%
18/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
6.3%
18/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
6.7%
19/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
Psychiatric disorders
Somnolence
|
3.6%
10/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
3.8%
11/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
6.3%
18/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
7.8%
22/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
Psychiatric disorders
Insomnia
|
2.8%
8/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
6.6%
19/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
5.6%
16/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
4.3%
12/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
4.6%
13/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
4.9%
14/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
5.2%
15/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
5.0%
14/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
3.9%
11/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
4.2%
12/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
4.5%
13/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
5.3%
15/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
|
General disorders
Fatigue
|
3.2%
9/281 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
3.8%
11/288 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
3.8%
11/287 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
7.1%
20/282 • From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).
|
Additional Information
Suresh Durgam, MD Clinical Asset Lead for Vilazodone - Senior Director - Clinical Development
Forest Research Institute
Phone: 201 427-8000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER