Trial Outcomes & Findings for Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder (NCT NCT01878292)
NCT ID: NCT01878292
Last Updated: 2019-12-24
Results Overview
The Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 133 (indicative of depression) is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
529 participants
Primary outcome timeframe
From Baseline to week 8
Results posted on
2019-12-24
Participant Flow
Randomization and treatment assignment were based on a randomization scheme prepared by Allergan Biostatistics prior to the start of the study
Participant milestones
| Measure |
Placebo
Dose-matched placebo tablets, once per day, oral administration
|
Vilazodone 15 mg
15 mg vilazodone tablets, once per day, oral administration
|
Vilazodone 30 mg
30 mg vilazodone tablets, once per day, oral administration
|
|---|---|---|---|
|
Randomized
STARTED
|
174
|
175
|
180
|
|
Randomized
COMPLETED
|
171
|
175
|
180
|
|
Randomized
NOT COMPLETED
|
3
|
0
|
0
|
|
Double-blind Treatment Period
STARTED
|
171
|
175
|
180
|
|
Double-blind Treatment Period
COMPLETED
|
142
|
149
|
161
|
|
Double-blind Treatment Period
NOT COMPLETED
|
29
|
26
|
19
|
|
Double-blind Down-Taper Period
STARTED
|
127
|
140
|
146
|
|
Double-blind Down-Taper Period
COMPLETED
|
122
|
132
|
142
|
|
Double-blind Down-Taper Period
NOT COMPLETED
|
5
|
8
|
4
|
Reasons for withdrawal
| Measure |
Placebo
Dose-matched placebo tablets, once per day, oral administration
|
Vilazodone 15 mg
15 mg vilazodone tablets, once per day, oral administration
|
Vilazodone 30 mg
30 mg vilazodone tablets, once per day, oral administration
|
|---|---|---|---|
|
Randomized
Protocol Violation
|
1
|
0
|
0
|
|
Randomized
Lost to Follow-up
|
1
|
0
|
0
|
|
Randomized
Adverse Event
|
1
|
0
|
0
|
|
Double-blind Treatment Period
Other Reasons
|
2
|
0
|
0
|
|
Double-blind Treatment Period
Lost to Follow-up
|
6
|
3
|
1
|
|
Double-blind Treatment Period
Withdrawal by Subject
|
9
|
7
|
8
|
|
Double-blind Treatment Period
Protocol Violation
|
3
|
4
|
2
|
|
Double-blind Treatment Period
Lack of Efficacy
|
5
|
3
|
0
|
|
Double-blind Treatment Period
Adverse Event
|
4
|
9
|
8
|
|
Double-blind Down-Taper Period
Withdrawal by Subject
|
5
|
8
|
4
|
Baseline Characteristics
Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
Placebo
n=171 Participants
Dose-matched placebo tablets, once per day, oral administration
|
Vilazodone 15 mg
n=175 Participants
15 mg vilazodone tablets, once per day, oral administration
|
Vilazodone 30 mg
n=180 Participants
30 mg vilazodone tablets, once per day, oral administration
|
Total
n=526 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
14.9 Years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
14.9 Years
STANDARD_DEVIATION 1.6 • n=7 Participants
|
14.6 Years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
14.8 Years
STANDARD_DEVIATION 1.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
313 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
213 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
150 Participants
n=5 Participants
|
153 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
464 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
|
110 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
346 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
45 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
142 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Weight
|
71.87 kg
STANDARD_DEVIATION 20.78 • n=5 Participants
|
70.10 kg
STANDARD_DEVIATION 20.65 • n=7 Participants
|
70.89 kg
STANDARD_DEVIATION 20.58 • n=5 Participants
|
70.95 kg
STANDARD_DEVIATION 20.64 • n=4 Participants
|
|
BMI
|
25.97 kg/m2
STANDARD_DEVIATION 7.15 • n=5 Participants
|
25.30 kg/m2
STANDARD_DEVIATION 6.86 • n=7 Participants
|
25.66 kg/m2
STANDARD_DEVIATION 6.70 • n=5 Participants
|
25.64 kg/m2
STANDARD_DEVIATION 6.89 • n=4 Participants
|
PRIMARY outcome
Timeframe: From Baseline to week 8Population: The Intent-to-Treat (ITT) Population will consist of all patients in the Safety Population who had baseline and at least 1 postbaseline assessment of the Children's Depression Rating Scale-Revised (CDRS-R) total score.
The Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 133 (indicative of depression) is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood.
Outcome measures
| Measure |
Placebo
n=170 Participants
Dose-matched placebo tablets, once per day, oral administration
|
Vilazodone 15 mg
n=174 Participants
15 mg vilazodone tablets, once per day, oral administration
|
Vilazodone 30 mg
n=180 Participants
30 mg vilazodone tablets, once per day, oral administration
|
|---|---|---|---|
|
Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score
|
-22.48 units on a scale
Standard Error 0.921
|
-22.94 units on a scale
Standard Error 0.904
|
-24.22 units on a scale
Standard Error 0.872
|
SECONDARY outcome
Timeframe: From Baseline to Week 8Population: The Intent-to-Treat (ITT) Population will consist of all patients in the Safety Population who had baseline and at least 1 postbaseline assessment of the Children's Depression Rating Scale-Revised (CDRS-R) total score.
The Clinical Global Impressions-Severity (CGI-S) is a clinician-rated instrument used to rate the severity of the patient's current state of mental illness compared with the clinician's total experience with patients with major depressive disorder (MDD). The severity of the patient's MDD was rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating a patient who is among the most extremely ill patients.
Outcome measures
| Measure |
Placebo
n=170 Participants
Dose-matched placebo tablets, once per day, oral administration
|
Vilazodone 15 mg
n=174 Participants
15 mg vilazodone tablets, once per day, oral administration
|
Vilazodone 30 mg
n=180 Participants
30 mg vilazodone tablets, once per day, oral administration
|
|---|---|---|---|
|
Change in Clinical Global Impressions-Severity (CGI-S) Score
|
-1.60 units on a scale
Standard Error 0.094
|
-1.82 units on a scale
Standard Error 0.092
|
-1.87 units on a scale
Standard Error 0.089
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 63 other events
Deaths: 0 deaths
Vilazodone 15 mg
Serious events: 2 serious events
Other events: 81 other events
Deaths: 0 deaths
Vilazodone 30 mg
Serious events: 3 serious events
Other events: 97 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=171 participants at risk
Dose-matched placebo tablets, once per day, oral administration
|
Vilazodone 15 mg
n=175 participants at risk
15 mg vilazodone tablets, once per day, oral administration
|
Vilazodone 30 mg
n=180 participants at risk
30 mg vilazodone tablets, once per day, oral administration
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/171 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
0.00%
0/175 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
0.56%
1/180 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
|
Skin and subcutaneous tissue disorders
Pilonidal cyst
|
0.00%
0/171 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
0.00%
0/175 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
0.56%
1/180 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
|
Psychiatric disorders
Suicidal ideation
|
0.58%
1/171 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
0.00%
0/175 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
0.56%
1/180 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/171 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
0.00%
0/175 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
0.56%
1/180 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/171 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
0.57%
1/175 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
0.00%
0/180 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/171 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
0.57%
1/175 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
0.00%
0/180 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
Other adverse events
| Measure |
Placebo
n=171 participants at risk
Dose-matched placebo tablets, once per day, oral administration
|
Vilazodone 15 mg
n=175 participants at risk
15 mg vilazodone tablets, once per day, oral administration
|
Vilazodone 30 mg
n=180 participants at risk
30 mg vilazodone tablets, once per day, oral administration
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
8.2%
14/171 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
30.3%
53/175 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
27.8%
50/180 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.4%
11/171 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
4.0%
7/175 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
15.6%
28/180 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
|
Gastrointestinal disorders
Vomiting
|
3.5%
6/171 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
6.3%
11/175 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
11.7%
21/180 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.7%
8/171 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
8.6%
15/175 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
8.9%
16/180 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
|
Infections and infestations
Nasopharyngitis
|
3.5%
6/171 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
3.4%
6/175 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
7.2%
13/180 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
|
Nervous system disorders
Headache
|
16.4%
28/171 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
14.3%
25/175 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
16.7%
30/180 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
|
Nervous system disorders
Dizziness
|
2.9%
5/171 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
4.6%
8/175 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
7.2%
13/180 • Adverse event data was collected for up to 10 weeks, including approximately 1 week of screening, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All data generated in this study are the property of the sponsor. 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 the sponsor and will follow sponsor's standard operating procedures on publications.
- Publication restrictions are in place
Restriction type: OTHER