Trial Outcomes & Findings for Safety, Efficacy and Tolerability of Vilazodone in (GAD) Generalized Anxiety Disorder (NCT NCT01844115)
NCT ID: NCT01844115
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
415 participants
Primary outcome timeframe
Baseline to Week 8
Results posted on
2019-12-18
Participant Flow
Participant milestones
| Measure |
Placebo
Dose-matched placebo tablets, oral administration
|
Vilazodone
Vilazodone tablets, oral administration
|
|---|---|---|
|
Overall Study
STARTED
|
202
|
202
|
|
Overall Study
COMPLETED
|
163
|
144
|
|
Overall Study
NOT COMPLETED
|
39
|
58
|
Reasons for withdrawal
| Measure |
Placebo
Dose-matched placebo tablets, oral administration
|
Vilazodone
Vilazodone tablets, oral administration
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
22
|
|
Overall Study
Lack of Efficacy
|
1
|
4
|
|
Overall Study
Protocol Violation
|
12
|
10
|
|
Overall Study
Withdrawal by Subject
|
11
|
11
|
|
Overall Study
Lost to Follow-up
|
11
|
10
|
|
Overall Study
Pregnancy
|
0
|
1
|
Baseline Characteristics
Safety, Efficacy and Tolerability of Vilazodone in (GAD) Generalized Anxiety Disorder
Baseline characteristics by cohort
| Measure |
Placebo
n=202 Participants
Dose-matched placebo tablets, oral administration
|
Vilazodone
n=202 Participants
Vilazodone tablets, oral administration
|
Total
n=404 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.7 Years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
39.2 Years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
39.9 Years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
|
Age, Customized
< 20
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Customized
20-29
|
53 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Age, Customized
30-39
|
42 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Age, Customized
40-49
|
46 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Age, Customized
50-59
|
36 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Age, Customized
≥ 60
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
65 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
137 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
264 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
177 Participants
n=5 Participants
|
180 Participants
n=7 Participants
|
357 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
|
153 Participants
n=5 Participants
|
158 Participants
n=7 Participants
|
311 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
38 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 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 the 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=200 Participants
Dose-matched placebo tablets, oral administration
|
Vilazodone
n=200 Participants
Vilazodone tablets, oral administration
|
|---|---|---|
|
Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
|
14.7 Score on Scale
Standard Deviation 7.41
|
11.3 Score on Scale
Standard Deviation 6.99
|
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 the 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=200 Participants
Dose-matched placebo tablets, oral administration
|
Vilazodone
n=200 Participants
Vilazodone tablets, oral administration
|
|---|---|---|
|
Change From Baseline in the Sheehan Disability Scale (SDS) Total Score
|
9.2 Score on scale
Standard Deviation 6.96
|
7.4 Score on scale
Standard Deviation 6.96
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 81 other events
Deaths: 0 deaths
Vilazodone
Serious events: 3 serious events
Other events: 115 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=202 participants at risk
Dose-matched placebo tablets, oral administration
|
Vilazodone
n=202 participants at risk
Vilazodone tablets, oral administration
|
|---|---|---|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/202 • 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.
|
0.50%
1/202 • 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
Urinary tract infection,
|
0.00%
0/202 • 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.
|
0.50%
1/202 • 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
Impaired gastric emptying
|
0.00%
0/202 • 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.
|
0.50%
1/202 • 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.
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.00%
0/202 • 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.
|
0.50%
1/202 • 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=202 participants at risk
Dose-matched placebo tablets, oral administration
|
Vilazodone
n=202 participants at risk
Vilazodone tablets, oral administration
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
12.9%
26/202 • 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.
|
29.7%
60/202 • 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
|
5.9%
12/202 • 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.
|
27.7%
56/202 • 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
|
5.9%
12/202 • 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.
|
5.9%
12/202 • 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
|
5.4%
11/202 • 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.
|
2.5%
5/202 • 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
|
4.0%
8/202 • 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.
|
10.9%
22/202 • 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
|
17.8%
36/202 • 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.
|
10.9%
22/202 • 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
Somnolence
|
3.0%
6/202 • 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.
|
5.9%
12/202 • 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
|
4.0%
8/202 • 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.
|
7.4%
15/202 • 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.
|
|
Reproductive system and breast disorders
Ejaculation delayed +
|
1.5%
1/65 • 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%
4/75 • 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.
|
|
Reproductive system and breast disorders
Erectile dysfunction +
|
1.5%
1/65 • 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%
4/75 • 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 investigator will be subject to mutual agreement between the investigator and Forest Research Institute, Inc.
- Publication restrictions are in place
Restriction type: OTHER