Trial Outcomes & Findings for Safety, Efficacy and Tolerability of Vilazodone in Generalized Anxiety Disorder (NCT NCT01629966)
NCT ID: NCT01629966
Last Updated: 2019-12-18
Results Overview
The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale which consists of 14 items, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The highest possible score is 56, which represents the most severe form of anxiety; the lowest possible score is 0, which represents an absence of anxiety.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
680 participants
Primary outcome timeframe
Baseline to Week 8
Results posted on
2019-12-18
Participant Flow
Participant milestones
| Measure |
Placebo
Dose-matched placebo one per day, oral administration
|
Vilazadone 20mg
Vilazodone 20mg once per day, oral administration.
|
Vilazodone 40mg
Vilazodone 40mg once per day, oral administration
|
|---|---|---|---|
|
Overall Study
STARTED
|
221
|
227
|
225
|
|
Overall Study
COMPLETED
|
180
|
175
|
159
|
|
Overall Study
NOT COMPLETED
|
41
|
52
|
66
|
Reasons for withdrawal
| Measure |
Placebo
Dose-matched placebo one per day, oral administration
|
Vilazadone 20mg
Vilazodone 20mg once per day, oral administration.
|
Vilazodone 40mg
Vilazodone 40mg once per day, oral administration
|
|---|---|---|---|
|
Overall Study
Pregnancy
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
10
|
13
|
9
|
|
Overall Study
Withdrawal by Subject
|
8
|
9
|
16
|
|
Overall Study
Protocol Violation
|
7
|
9
|
7
|
|
Overall Study
Lack of Efficacy
|
5
|
2
|
4
|
|
Overall Study
Adverse Event
|
11
|
18
|
30
|
Baseline Characteristics
Safety, Efficacy and Tolerability of Vilazodone in Generalized Anxiety Disorder
Baseline characteristics by cohort
| Measure |
Placebo
n=221 Participants
Dose-matched placebo one per day, oral administration
|
Vilazadone 20mg
n=227 Participants
Vilazodone 20mg once per day, oral administration.
|
Vilazodone 40mg
n=225 Participants
Vilazodone 40mg once per day, oral administration
|
Total
n=673 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40.0 Years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
40.6 Years
STANDARD_DEVIATION 13.7 • n=7 Participants
|
39.9 Years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
40.2 Years
STANDARD_DEVIATION 13.5 • n=4 Participants
|
|
Age, Customized
< 20
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Age, Customized
20-29
|
59 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
166 Participants
n=4 Participants
|
|
Age, Customized
30-39
|
50 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
154 Participants
n=4 Participants
|
|
Age, Customized
40-49
|
43 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
140 Participants
n=4 Participants
|
|
Age, Customized
50-59
|
44 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
131 Participants
n=4 Participants
|
|
Age, Customized
≥ 60
|
19 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Male
|
78 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
239 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Female
|
143 Participants
n=5 Participants
|
149 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
434 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
198 Participants
n=5 Participants
|
202 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
594 Participants
n=4 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
|
|
Race/Ethnicity, Customized
White
|
174 Participants
n=5 Participants
|
167 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
508 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
35 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
131 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 8Population: The Intent-to-Treat (ITT) Population consisted of all patients in the Safety Population who had at least 1 postbaseline assessment of HAM-A.
The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale which consists of 14 items, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The highest possible score is 56, which represents the most severe form of anxiety; the lowest possible score is 0, which represents an absence of anxiety.
Outcome measures
| Measure |
Placebo
n=221 Participants
Dose-matched placebo one per day, oral administration
|
Vilazadone 20mg
n=223 Participants
Vilazodone 20mg once per day, oral administration.
|
Vilazodone 40mg
n=223 Participants
Vilazodone 40mg once per day, oral administration
|
|---|---|---|---|
|
Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
|
13.1 Score on scale
Standard Deviation 7.93
|
12.0 Score on scale
Standard Deviation 7.13
|
11.2 Score on scale
Standard Deviation 7.46
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: The Intent-to-Treat (ITT) Population consisted of all patients in the Safety Population who had at least 1 postbaseline assessment of HAM-A.
The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe).
Outcome measures
| Measure |
Placebo
n=221 Participants
Dose-matched placebo one per day, oral administration
|
Vilazadone 20mg
n=223 Participants
Vilazodone 20mg once per day, oral administration.
|
Vilazodone 40mg
n=223 Participants
Vilazodone 40mg once per day, oral administration
|
|---|---|---|---|
|
Change From Baseline in the Sheehan Disability Scale (SDS) Total Score
|
8.4 Score on Scale
Standard Deviation 7.53
|
7.7 Score on Scale
Standard Deviation 6.51
|
6.7 Score on Scale
Standard Deviation 6.62
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 85 other events
Deaths: 0 deaths
Vilazadone 20mg
Serious events: 1 serious events
Other events: 123 other events
Deaths: 0 deaths
Vilazodone 40mg
Serious events: 0 serious events
Other events: 121 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=221 participants at risk
Dose-matched placebo one per day, oral administration
|
Vilazadone 20mg
n=227 participants at risk
Vilazodone 20mg once per day, oral administration.
|
Vilazodone 40mg
n=225 participants at risk
Vilazodone 40mg once per day, oral administration
|
|---|---|---|---|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/221 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
0.44%
1/227 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
0.00%
0/225 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
|
Blood and lymphatic system disorders
left carpal canal hematoma
|
0.45%
1/221 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
0.00%
0/227 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
0.00%
0/225 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
Other adverse events
| Measure |
Placebo
n=221 participants at risk
Dose-matched placebo one per day, oral administration
|
Vilazadone 20mg
n=227 participants at risk
Vilazodone 20mg once per day, oral administration.
|
Vilazodone 40mg
n=225 participants at risk
Vilazodone 40mg once per day, oral administration
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
11.3%
25/221 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
24.2%
55/227 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
25.8%
58/225 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.4%
23/221 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
25.1%
57/227 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
21.3%
48/225 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
|
Gastrointestinal disorders
Vomiting
|
2.3%
5/221 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
5.7%
13/227 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
7.6%
17/225 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
|
Gastrointestinal disorders
Dry mouth
|
5.4%
12/221 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
4.4%
10/227 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
4.4%
10/225 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
|
General disorders
Fatigue
|
2.7%
6/221 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
3.1%
7/227 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
5.8%
13/225 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.2%
16/221 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
4.8%
11/227 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
5.3%
12/225 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
|
Nervous system disorders
Headache
|
8.1%
18/221 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
14.1%
32/227 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
11.1%
25/225 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
|
Nervous system disorders
Dizziness
|
3.6%
8/221 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
5.3%
12/227 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
9.3%
21/225 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
|
Psychiatric disorders
Insomnia
|
5.0%
11/221 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
5.3%
12/227 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
5.8%
13/225 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
Additional Information
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 PI will be subject to mutual agreement between the PI and Forest Research Institute, Inc.
- Publication restrictions are in place
Restriction type: OTHER