VLZ-MD-21: Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone relative to placebo in adolescent outpatients (12-17) with major depressive disorder.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Placebo Comparator: Placebo Dose-matched placebo tablets, once per day, oral administration |
Drug: Placebo
Dose matched placebo tablets, once per day, oral administration.
|
Experimental: Vilazodone 15 mg 15 mg vilazodone tablets, once per day, oral administration |
Drug: Vilazodone
Vilazodone tablets, 15 mg per day, oral administration
Other Names:
|
Experimental: vilazodone 30 mg 30 mg vilazodone tablets, once per day, oral administration |
Drug: Vilazodone
Vilazodone tablets, 30 mg once per day, oral administration
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score [From Baseline to week 8]
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.
Secondary Outcome Measures
- Change in Clinical Global Impressions-Severity (CGI-S) Score [From Baseline to Week 8]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or Female outpatients between 12-17 years of age
-
Primary diagnosis of major depressive disorder (MDD)
-
Children's Depression Rating Scale-Revised (CDRS-R) score of 40 or greater
-
Clinical Global Impressions-Severity (CGI-S) score of 4 or greater
Exclusion Criteria:
-
Current (past 3 months) principal Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) based diagnosis of an axis disorder other than major depressive disorder (MDD) that is the primary focus of treatment.
-
History of suicidal behavior, or requires precaution against suicide
-
Not generally healthy medical condition
-
Seizure disorder
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Forest Investigative Site 073 | Imperial | California | United States | 92251 |
2 | Forest Investigative Site 052 | Los Angeles | California | United States | 90027 |
3 | Forest Investigative Site 023 | Murrieta | California | United States | 92562 |
4 | Forest Investigative Site 004 | Orange | California | United States | 92868 |
5 | Forest Investigative Site 037 | San Diego | California | United States | 92108 |
6 | Forest Investigative Site 006 | Washington | District of Columbia | United States | 20010 |
7 | Forest Investigative Site 039 | Gainesville | Florida | United States | 32607 |
8 | Forest Investigative Site 009 | Jacksonville Beach | Florida | United States | 32250 |
9 | Forest Investigative Site 063 | Miami | Florida | United States | 33155 |
10 | Forest Investigative Site 034 | Oakland Park | Florida | United States | 33334 |
11 | Forest Investigative Site 016 | Orlando | Florida | United States | 32803 |
12 | Forest Investigative Site 064 | Orlando | Florida | United States | 32806 |
13 | Forest Investigative Site 014 | Atlanta | Georgia | United States | 30308 |
14 | Forest Investigative Site 030 | Roswell | Georgia | United States | 30076 |
15 | Forest Investigative Site 032 | Libertyville | Illinois | United States | 60048 |
16 | Forest Investigative Site 048 | Naperville | Illinois | United States | 60563 |
17 | Forest Investigative Site 051 | Terre Haute | Indiana | United States | 47802 |
18 | Forest Investigative Site 013 | Overland Park | Kansas | United States | 66211 |
19 | Forest Investigative Site 070 | Lake Charles | Louisiana | United States | 70629 |
20 | Forest Investigative Site 050 | Baltimore | Maryland | United States | 21205 |
21 | Forest Investigative Site 054 | Baltimore | Maryland | United States | 21208 |
22 | Forest Investigative Site 049 | Rockville | Maryland | United States | 20852 |
23 | Forest Investigative Site 026 | Watertown | Massachusetts | United States | 02472 |
24 | Forest Investigative Site 024 | Rochester Hills | Michigan | United States | 48307 |
25 | Forest Investigative Site 015 | Creve Coeur | Missouri | United States | 63141 |
26 | Forest Investigative Site 055 | Saint Charles | Missouri | United States | 63304 |
27 | Forest Investigative Site 072 | Saint Louis | Missouri | United States | 63128 |
28 | Forest Investigative Site 066 | Las Vegas | Nevada | United States | 89128 |
29 | Forest Investigative Site 007 | Cherry Hill | New Jersey | United States | 08002 |
30 | Forest Investigative Site 071 | Neptune | New Jersey | United States | 07752 |
31 | Forest Investigative Site 008 | Albuquerque | New Mexico | United States | 87109 |
32 | Forest Investigative Site 057 | Rochester | New York | United States | 14618 |
33 | Forest Investigative Site 059 | Durham | North Carolina | United States | 27705 |
34 | Forest Investigative Site 053 | Avon Lake | Ohio | United States | 44012 |
35 | Forest Investigative Site 021 | Canton | Ohio | United States | 44718 |
36 | Forest Investigative Site 012 | Cincinnati | Ohio | United States | 45219 |
37 | Forest Investigative Site 029 | Columbus | Ohio | United States | 43210 |
38 | Forest Investigative Site 018 | Oklahoma City | Oklahoma | United States | 73103 |
39 | Forest Investigative Site 011 | Oklahoma City | Oklahoma | United States | 73112 |
40 | Forest Investigative Site 065 | Tulsa | Oklahoma | United States | 74104 |
41 | Forest Investigative Site 040 | Philadelphia | Pennsylvania | United States | 19139 |
42 | Forest Investigative Site 074 | Charleston | South Carolina | United States | 29407 |
43 | Forest Investigative Site 062 | Memphis | Tennessee | United States | 38119 |
44 | Forest Investigative Site 001 | Dallas | Texas | United States | 75235 |
45 | Forest Investigative Site 027 | Houston | Texas | United States | 77098 |
46 | Forest Investigative Site 041 | Plano | Texas | United States | 75093 |
47 | Forest Investigative Site 045 | The Woodlands | Texas | United States | 77381 |
48 | Forest Investigative Site 019 | Clinton | Utah | United States | 84015 |
49 | Forest Investigative Site 060 | Richmond | Virginia | United States | 23230 |
50 | Forest Investigative Site 035 | Bellevue | Washington | United States | 98007 |
51 | Forest Investigative Site 068 | Bothell | Washington | United States | 98011 |
52 | Forest Investigative Site 022 | Kirkland | Washington | United States | 98033 |
Sponsors and Collaborators
- Forest Laboratories
Investigators
- Study Director: Chandran Prakash, Allergan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VLZ-MD-21
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | Randomization and treatment assignment were based on a randomization scheme prepared by Allergan Biostatistics prior to the start of the study |
Arm/Group Title | Placebo | Vilazodone 15 mg | Vilazodone 30 mg |
---|---|---|---|
Arm/Group Description | Dose-matched placebo tablets, once per day, oral administration | 15 mg vilazodone tablets, once per day, oral administration | 30 mg vilazodone tablets, once per day, oral administration |
Period Title: Randomized | |||
STARTED | 174 | 175 | 180 |
COMPLETED | 171 | 175 | 180 |
NOT COMPLETED | 3 | 0 | 0 |
Period Title: Randomized | |||
STARTED | 171 | 175 | 180 |
COMPLETED | 142 | 149 | 161 |
NOT COMPLETED | 29 | 26 | 19 |
Period Title: Randomized | |||
STARTED | 127 | 140 | 146 |
COMPLETED | 122 | 132 | 142 |
NOT COMPLETED | 5 | 8 | 4 |
Baseline Characteristics
Arm/Group Title | Placebo | Vilazodone 15 mg | Vilazodone 30 mg | Total |
---|---|---|---|---|
Arm/Group Description | Dose-matched placebo tablets, once per day, oral administration | 15 mg vilazodone tablets, once per day, oral administration | 30 mg vilazodone tablets, once per day, oral administration | Total of all reporting groups |
Overall Participants | 171 | 175 | 180 | 526 |
Age (Years) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [Years] |
14.9
(1.7)
|
14.9
(1.6)
|
14.6
(1.6)
|
14.8
(1.6)
|
Sex: Female, Male (Count of Participants) | ||||
Female |
103
60.2%
|
103
58.9%
|
107
59.4%
|
313
59.5%
|
Male |
68
39.8%
|
72
41.1%
|
73
40.6%
|
213
40.5%
|
Ethnicity (NIH/OMB) (Count of Participants) | ||||
Hispanic or Latino |
21
12.3%
|
22
12.6%
|
19
10.6%
|
62
11.8%
|
Not Hispanic or Latino |
150
87.7%
|
153
87.4%
|
161
89.4%
|
464
88.2%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Race/Ethnicity, Customized (Number) [Number] | ||||
White |
110
64.3%
|
115
65.7%
|
121
67.2%
|
346
65.8%
|
Black or African American |
45
26.3%
|
48
27.4%
|
49
27.2%
|
142
27%
|
Asian |
6
3.5%
|
3
1.7%
|
0
0%
|
9
1.7%
|
American Indian or Alaska Native |
2
1.2%
|
2
1.1%
|
4
2.2%
|
8
1.5%
|
Native Hawaiian/Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Other |
8
4.7%
|
7
4%
|
6
3.3%
|
21
4%
|
Weight (kg) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [kg] |
71.87
(20.78)
|
70.10
(20.65)
|
70.89
(20.58)
|
70.95
(20.64)
|
BMI (kg/m2) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [kg/m2] |
25.97
(7.15)
|
25.30
(6.86)
|
25.66
(6.70)
|
25.64
(6.89)
|
Outcome Measures
Title | Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score |
---|---|
Description | 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. |
Time Frame | From Baseline to week 8 |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Placebo | Vilazodone 15 mg | Vilazodone 30 mg |
---|---|---|---|
Arm/Group Description | Dose-matched placebo tablets, once per day, oral administration | 15 mg vilazodone tablets, once per day, oral administration | 30 mg vilazodone tablets, once per day, oral administration |
Measure Participants | 170 | 174 | 180 |
Least Squares Mean (Standard Error) [units on a scale] |
-22.48
(0.921)
|
-22.94
(0.904)
|
-24.22
(0.872)
|
Title | Change in Clinical Global Impressions-Severity (CGI-S) Score |
---|---|
Description | 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. |
Time Frame | From Baseline to Week 8 |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Placebo | Vilazodone 15 mg | Vilazodone 30 mg |
---|---|---|---|
Arm/Group Description | Dose-matched placebo tablets, once per day, oral administration | 15 mg vilazodone tablets, once per day, oral administration | 30 mg vilazodone tablets, once per day, oral administration |
Measure Participants | 170 | 174 | 180 |
Least Squares Mean (Standard Error) [units on a scale] |
-1.60
(0.094)
|
-1.82
(0.092)
|
-1.87
(0.089)
|
Adverse Events
Time Frame | 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. | |||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||
Arm/Group Title | Placebo | Vilazodone 15 mg | Vilazodone 30 mg | |||
Arm/Group Description | Dose-matched placebo tablets, once per day, oral administration | 15 mg vilazodone tablets, once per day, oral administration | 30 mg vilazodone tablets, once per day, oral administration | |||
All Cause Mortality |
||||||
Placebo | Vilazodone 15 mg | Vilazodone 30 mg | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/171 (0%) | 0/175 (0%) | 0/180 (0%) | |||
Serious Adverse Events |
||||||
Placebo | Vilazodone 15 mg | Vilazodone 30 mg | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/171 (0.6%) | 2/175 (1.1%) | 3/180 (1.7%) | |||
Injury, poisoning and procedural complications | ||||||
Intentional overdose | 0/171 (0%) | 0/175 (0%) | 1/180 (0.6%) | |||
Investigations | ||||||
Alanine aminotransferase increased | 0/171 (0%) | 1/175 (0.6%) | 0/180 (0%) | |||
Psychiatric disorders | ||||||
Suicidal ideation | 1/171 (0.6%) | 0/175 (0%) | 1/180 (0.6%) | |||
Suicide attempt | 0/171 (0%) | 0/175 (0%) | 1/180 (0.6%) | |||
Mental status changes | 0/171 (0%) | 1/175 (0.6%) | 0/180 (0%) | |||
Skin and subcutaneous tissue disorders | ||||||
Pilonidal cyst | 0/171 (0%) | 0/175 (0%) | 1/180 (0.6%) | |||
Other (Not Including Serious) Adverse Events |
||||||
Placebo | Vilazodone 15 mg | Vilazodone 30 mg | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 63/171 (36.8%) | 81/175 (46.3%) | 97/180 (53.9%) | |||
Gastrointestinal disorders | ||||||
Nausea | 14/171 (8.2%) | 53/175 (30.3%) | 50/180 (27.8%) | |||
Abdominal pain upper | 11/171 (6.4%) | 7/175 (4%) | 28/180 (15.6%) | |||
Vomiting | 6/171 (3.5%) | 11/175 (6.3%) | 21/180 (11.7%) | |||
Diarrhoea | 8/171 (4.7%) | 15/175 (8.6%) | 16/180 (8.9%) | |||
Infections and infestations | ||||||
Nasopharyngitis | 6/171 (3.5%) | 6/175 (3.4%) | 13/180 (7.2%) | |||
Nervous system disorders | ||||||
Headache | 28/171 (16.4%) | 25/175 (14.3%) | 30/180 (16.7%) | |||
Dizziness | 5/171 (2.9%) | 8/175 (4.6%) | 13/180 (7.2%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
Name/Title | Therapeutic Area, Head |
---|---|
Organization | Allergan |
Phone | 714-246-4500 |
IR-CTRegistration@allergan.com |
- VLZ-MD-21