Trial Outcomes & Findings for Safety, Efficacy, and Tolerability of Vilazodone in Major Depressive Disorder (NCT NCT01473394)
NCT ID: NCT01473394
Last Updated: 2014-04-03
Results Overview
The MADRS is a clinician-rated scale for assessing depressive symptomatology that had occurred in participants during the week preceding each interview. Patients were rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores on the 10 items and ranged from 0 to 60. A higher score indicated more depressive symptomatology. A negative change score indicated improvement.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
518 participants
Primary outcome timeframe
Baseline to Week 8
Results posted on
2014-04-03
Participant Flow
Participant milestones
| Measure |
Dose-matched Placebo
Participants received dose-matched placebo orally once daily for 9 weeks.
|
Vilazodone
Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
|
|---|---|---|
|
Overall Study
STARTED
|
253
|
255
|
|
Overall Study
COMPLETED
|
208
|
212
|
|
Overall Study
NOT COMPLETED
|
45
|
43
|
Reasons for withdrawal
| Measure |
Dose-matched Placebo
Participants received dose-matched placebo orally once daily for 9 weeks.
|
Vilazodone
Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
|
|---|---|---|
|
Overall Study
Adverse Event
|
13
|
16
|
|
Overall Study
Insufficient Therapeutic Response
|
4
|
1
|
|
Overall Study
Protocol Violation
|
7
|
5
|
|
Overall Study
Withdrew Consent
|
12
|
10
|
|
Overall Study
Lost to Follow-up
|
9
|
11
|
Baseline Characteristics
Safety, Efficacy, and Tolerability of Vilazodone in Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
Dose-matched Placebo
n=253 Participants
Participants received dose-matched placebo orally once daily for 9 weeks.
|
Vilazodone
n=255 Participants
Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
|
Total
n=508 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.1 Years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
39.3 Years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
40.2 Years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
|
Age, Customized
< 20
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Customized
≥ 20-29
|
53 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Age, Customized
≥ 30-39
|
54 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Age, Customized
≥ 40-49
|
67 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Age, Customized
≥ 50-59
|
48 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Age, Customized
≥ 60
|
24 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
142 Participants
n=5 Participants
|
131 Participants
n=7 Participants
|
273 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
111 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
235 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
33 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
220 Participants
n=5 Participants
|
213 Participants
n=7 Participants
|
433 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
168 Participants
n=5 Participants
|
174 Participants
n=7 Participants
|
342 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
70 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Weight
|
84.68 kg
STANDARD_DEVIATION 17.84 • n=5 Participants
|
82.89 kg
STANDARD_DEVIATION 18.39 • n=7 Participants
|
83.78 kg
STANDARD_DEVIATION 18.12 • n=5 Participants
|
|
Height
|
170.15 cm
STANDARD_DEVIATION 9.12 • n=5 Participants
|
170.32 cm
STANDARD_DEVIATION 9.60 • n=7 Participants
|
170.23 cm
STANDARD_DEVIATION 9.36 • n=5 Participants
|
|
Body mass index
|
29.08 kg/m^2
STANDARD_DEVIATION 5.50 • n=5 Participants
|
28.41 kg/m^2
STANDARD_DEVIATION 5.47 • n=7 Participants
|
28.75 kg/m^2
STANDARD_DEVIATION 5.49 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 8Population: Intent-to-treat population: All randomized participants who received at least 1 dose of double-blind investigational product and who had a Baseline and at least 1 post-baseline assessment of the MADRS total score.
The MADRS is a clinician-rated scale for assessing depressive symptomatology that had occurred in participants during the week preceding each interview. Patients were rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores on the 10 items and ranged from 0 to 60. A higher score indicated more depressive symptomatology. A negative change score indicated improvement.
Outcome measures
| Measure |
Dose-matched Placebo
n=252 Participants
Participants received dose-matched placebo orally once daily for 9 weeks.
|
Vilazodone
n=253 Participants
Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
|
|---|---|---|
|
Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 8
|
-11.0 Units on a scale
Standard Error 0.65
|
-16.1 Units on a scale
Standard Error 0.64
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: Intent-to-treat population: All randomized participants who received at least 1 dose of double-blind investigational product and who had a Baseline and at least 1 post-baseline assessment of the MADRS total score.
The CGI-S is a clinician-rated scale for assessing the severity of the participant's current state of mental illness compared with a patient population with major depressive disorder. The clinician responded to the following question "Considering your total clinical experience with this population, how mentally ill is the participant at this time?" on a 7-point scale: 1=normal, not at all ill; 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The scale ranges from 1 to 7. A higher score indicates more severe mental illness. A negative change score indicates improvement.
Outcome measures
| Measure |
Dose-matched Placebo
n=252 Participants
Participants received dose-matched placebo orally once daily for 9 weeks.
|
Vilazodone
n=253 Participants
Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
|
|---|---|---|
|
Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score at Week 8
|
-1.2 Units on a scale
Standard Error 0.08
|
-1.8 Units on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: Intent-to-treat population: All randomized participants who received at least 1 dose of double-blind investigational product and who had a Baseline and at least 1 post-baseline assessment of the MADRS total score.
The MADRS Sustained response rate is defined as a MÅDRS total score ≤ 12 for at least the last 2 consecutive visits during the double-blind treatment period.
Outcome measures
| Measure |
Dose-matched Placebo
n=252 Participants
Participants received dose-matched placebo orally once daily for 9 weeks.
|
Vilazodone
n=253 Participants
Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
|
|---|---|---|
|
Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response Rate
|
17.1 Percentage of participants
Interval 12.4 to 21.7
|
27.3 Percentage of participants
Interval 21.8 to 32.8
|
Adverse Events
Dose-matched Placebo
Serious events: 2 serious events
Other events: 78 other events
Deaths: 0 deaths
Vilazodone
Serious events: 3 serious events
Other events: 149 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose-matched Placebo
n=253 participants at risk
Participants received dose-matched placebo orally once daily for 9 weeks.
|
Vilazodone
n=255 participants at risk
Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
|
|---|---|---|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/253 • Adverse events were reported from the time the participant signs the informed consent form until 30 days after the last dose of treatment (up to 13 weeks).
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product. The Severe Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
0.39%
1/255 • Adverse events were reported from the time the participant signs the informed consent form until 30 days after the last dose of treatment (up to 13 weeks).
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product. The Severe Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/253 • Adverse events were reported from the time the participant signs the informed consent form until 30 days after the last dose of treatment (up to 13 weeks).
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product. The Severe Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
0.39%
1/255 • Adverse events were reported from the time the participant signs the informed consent form until 30 days after the last dose of treatment (up to 13 weeks).
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product. The Severe Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.40%
1/253 • Adverse events were reported from the time the participant signs the informed consent form until 30 days after the last dose of treatment (up to 13 weeks).
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product. The Severe Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
0.00%
0/255 • Adverse events were reported from the time the participant signs the informed consent form until 30 days after the last dose of treatment (up to 13 weeks).
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product. The Severe Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/253 • Adverse events were reported from the time the participant signs the informed consent form until 30 days after the last dose of treatment (up to 13 weeks).
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product. The Severe Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
0.39%
1/255 • Adverse events were reported from the time the participant signs the informed consent form until 30 days after the last dose of treatment (up to 13 weeks).
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product. The Severe Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.40%
1/253 • Adverse events were reported from the time the participant signs the informed consent form until 30 days after the last dose of treatment (up to 13 weeks).
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product. The Severe Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
0.00%
0/255 • Adverse events were reported from the time the participant signs the informed consent form until 30 days after the last dose of treatment (up to 13 weeks).
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product. The Severe Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
|
Psychiatric disorders
Suicide attempt
|
0.40%
1/253 • Adverse events were reported from the time the participant signs the informed consent form until 30 days after the last dose of treatment (up to 13 weeks).
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product. The Severe Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
0.00%
0/255 • Adverse events were reported from the time the participant signs the informed consent form until 30 days after the last dose of treatment (up to 13 weeks).
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product. The Severe Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
Other adverse events
| Measure |
Dose-matched Placebo
n=253 participants at risk
Participants received dose-matched placebo orally once daily for 9 weeks.
|
Vilazodone
n=255 participants at risk
Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
10.3%
26/253 • Adverse events were reported from the time the participant signs the informed consent form until 30 days after the last dose of treatment (up to 13 weeks).
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product. The Severe Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
32.5%
83/255 • Adverse events were reported from the time the participant signs the informed consent form until 30 days after the last dose of treatment (up to 13 weeks).
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product. The Severe Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
|
Gastrointestinal disorders
Nausea
|
8.3%
21/253 • Adverse events were reported from the time the participant signs the informed consent form until 30 days after the last dose of treatment (up to 13 weeks).
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product. The Severe Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
24.7%
63/255 • Adverse events were reported from the time the participant signs the informed consent form until 30 days after the last dose of treatment (up to 13 weeks).
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product. The Severe Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
|
Nervous system disorders
Headache
|
10.3%
26/253 • Adverse events were reported from the time the participant signs the informed consent form until 30 days after the last dose of treatment (up to 13 weeks).
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product. The Severe Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
9.4%
24/255 • Adverse events were reported from the time the participant signs the informed consent form until 30 days after the last dose of treatment (up to 13 weeks).
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product. The Severe Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
|
Nervous system disorders
Dizziness
|
2.8%
7/253 • Adverse events were reported from the time the participant signs the informed consent form until 30 days after the last dose of treatment (up to 13 weeks).
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product. The Severe Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
7.1%
18/255 • Adverse events were reported from the time the participant signs the informed consent form until 30 days after the last dose of treatment (up to 13 weeks).
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product. The Severe Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
|
Psychiatric disorders
Insomnia
|
1.2%
3/253 • Adverse events were reported from the time the participant signs the informed consent form until 30 days after the last dose of treatment (up to 13 weeks).
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product. The Severe Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
5.9%
15/255 • Adverse events were reported from the time the participant signs the informed consent form until 30 days after the last dose of treatment (up to 13 weeks).
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product. The Severe Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.5%
14/253 • Adverse events were reported from the time the participant signs the informed consent form until 30 days after the last dose of treatment (up to 13 weeks).
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product. The Severe Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
3.9%
10/255 • Adverse events were reported from the time the participant signs the informed consent form until 30 days after the last dose of treatment (up to 13 weeks).
Safety population: All randomized participants who received at least 1 dose of double-blind investigational product. The Severe Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
Additional Information
Carl Gommoll
Forest Research Institute, Inc.
Phone: 201 427-8000
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