VLZ-MD-21: Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder

Sponsor
Forest Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT01878292
Collaborator
(none)
529
52
3
38.8
10.2
0.3

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

Study Type:
Interventional
Actual Enrollment :
529 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder
Actual Study Start Date :
Jul 11, 2013
Actual Primary Completion Date :
Mar 17, 2016
Actual Study Completion Date :
Oct 5, 2016

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:
  • Viibryd
  • 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:
  • Viibryd
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    Ages Eligible for Study:
    12 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.
    Responsible Party:
    Forest Laboratories
    ClinicalTrials.gov Identifier:
    NCT01878292
    Other Study ID Numbers:
    • VLZ-MD-21
    First Posted:
    Jun 14, 2013
    Last Update Posted:
    Dec 24, 2019
    Last Verified:
    Dec 1, 2019

    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

    1. Primary Outcome
    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)
    2. Secondary Outcome
    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

    [Not Specified]

    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
    Email IR-CTRegistration@allergan.com
    Responsible Party:
    Forest Laboratories
    ClinicalTrials.gov Identifier:
    NCT01878292
    Other Study ID Numbers:
    • VLZ-MD-21
    First Posted:
    Jun 14, 2013
    Last Update Posted:
    Dec 24, 2019
    Last Verified:
    Dec 1, 2019