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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Dose-matched placebo tablets, once per day, oral administration |
|
| Vilazodone 15 mg | Experimental | 15 mg vilazodone tablets, once per day, oral administration |
|
| vilazodone 30 mg | Experimental | 30 mg vilazodone tablets, once per day, oral administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Dose matched placebo tablets, once per day, oral administration. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 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. | From Baseline to week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinical Global Impressions-Severity (CGI-S) 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chandran Prakash | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Investigative Site 073 | Imperial | California | 92251 | United States | ||
| Forest Investigative Site 052 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29633166 | Derived | Durgam S, Chen C, Migliore R, Prakash C, Edwards J, Findling RL. A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Vilazodone in Adolescents with Major Depressive Disorder. Paediatr Drugs. 2018 Aug;20(4):353-363. doi: 10.1007/s40272-018-0290-4. |
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Randomization and treatment assignment were based on a randomization scheme prepared by Allergan Biostatistics prior to the start of the study
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Dose-matched placebo tablets, once per day, oral administration |
| FG001 | Vilazodone 15 mg | 15 mg vilazodone tablets, once per day, oral administration |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Randomized |
|
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| Vilazodone |
| Drug |
Vilazodone tablets, 15 mg per day, oral administration |
|
|
| Vilazodone | Drug | Vilazodone tablets, 30 mg once per day, oral administration |
|
|
| From Baseline to Week 8 |
| Los Angeles |
| California |
| 90027 |
| United States |
| Forest Investigative Site 023 | Murrieta | California | 92562 | United States |
| Forest Investigative Site 004 | Orange | California | 92868 | United States |
| Forest Investigative Site 037 | San Diego | California | 92108 | United States |
| Forest Investigative Site 006 | Washington D.C. | District of Columbia | 20010 | United States |
| Forest Investigative Site 039 | Gainesville | Florida | 32607 | United States |
| Forest Investigative Site 009 | Jacksonville Beach | Florida | 32250 | United States |
| Forest Investigative Site 063 | Miami | Florida | 33155 | United States |
| Forest Investigative Site 034 | Oakland Park | Florida | 33334 | United States |
| Forest Investigative Site 016 | Orlando | Florida | 32803 | United States |
| Forest Investigative Site 064 | Orlando | Florida | 32806 | United States |
| Forest Investigative Site 014 | Atlanta | Georgia | 30308 | United States |
| Forest Investigative Site 030 | Roswell | Georgia | 30076 | United States |
| Forest Investigative Site 032 | Libertyville | Illinois | 60048 | United States |
| Forest Investigative Site 048 | Naperville | Illinois | 60563 | United States |
| Forest Investigative Site 051 | Terre Haute | Indiana | 47802 | United States |
| Forest Investigative Site 013 | Overland Park | Kansas | 66211 | United States |
| Forest Investigative Site 070 | Lake Charles | Louisiana | 70629 | United States |
| Forest Investigative Site 050 | Baltimore | Maryland | 21205 | United States |
| Forest Investigative Site 054 | Baltimore | Maryland | 21208 | United States |
| Forest Investigative Site 049 | Rockville | Maryland | 20852 | United States |
| Forest Investigative Site 026 | Watertown | Massachusetts | 02472 | United States |
| Forest Investigative Site 024 | Rochester Hills | Michigan | 48307 | United States |
| Forest Investigative Site 015 | Creve Coeur | Missouri | 63141 | United States |
| Forest Investigative Site 055 | Saint Charles | Missouri | 63304 | United States |
| Forest Investigative Site 072 | St Louis | Missouri | 63128 | United States |
| Forest Investigative Site 066 | Las Vegas | Nevada | 89128 | United States |
| Forest Investigative Site 007 | Cherry Hill | New Jersey | 08002 | United States |
| Forest Investigative Site 071 | Neptune City | New Jersey | 07752 | United States |
| Forest Investigative Site 008 | Albuquerque | New Mexico | 87109 | United States |
| Forest Investigative Site 057 | Rochester | New York | 14618 | United States |
| Forest Investigative Site 059 | Durham | North Carolina | 27705 | United States |
| Forest Investigative Site 053 | Avon Lake | Ohio | 44012 | United States |
| Forest Investigative Site 021 | Canton | Ohio | 44718 | United States |
| Forest Investigative Site 012 | Cincinnati | Ohio | 45219 | United States |
| Forest Investigative Site 029 | Columbus | Ohio | 43210 | United States |
| Forest Investigative Site 018 | Oklahoma City | Oklahoma | 73103 | United States |
| Forest Investigative Site 011 | Oklahoma City | Oklahoma | 73112 | United States |
| Forest Investigative Site 065 | Tulsa | Oklahoma | 74104 | United States |
| Forest Investigative Site 040 | Philadelphia | Pennsylvania | 19139 | United States |
| Forest Investigative Site 074 | Charleston | South Carolina | 29407 | United States |
| Forest Investigative Site 062 | Memphis | Tennessee | 38119 | United States |
| Forest Investigative Site 001 | Dallas | Texas | 75235 | United States |
| Forest Investigative Site 027 | Houston | Texas | 77098 | United States |
| Forest Investigative Site 041 | Plano | Texas | 75093 | United States |
| Forest Investigative Site 045 | The Woodlands | Texas | 77381 | United States |
| Forest Investigative Site 019 | Clinton | Utah | 84015 | United States |
| Forest Investigative Site 060 | Richmond | Virginia | 23230 | United States |
| Forest Investigative Site 035 | Bellevue | Washington | 98007 | United States |
| Forest Investigative Site 068 | Bothell | Washington | 98011 | United States |
| Forest Investigative Site 022 | Kirkland | Washington | 98033 | United States |
| FG002 | Vilazodone 30 mg | 30 mg vilazodone tablets, once per day, oral administration |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Double-blind Treatment Period |
|
|
| Double-blind Down-Taper Period |
|
|
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Dose-matched placebo tablets, once per day, oral administration |
| BG001 | Vilazodone 15 mg | 15 mg vilazodone tablets, once per day, oral administration |
| BG002 | Vilazodone 30 mg | 30 mg vilazodone tablets, once per day, oral administration |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| BMI | Mean | Standard Deviation | kg/m2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | From Baseline to week 8 |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Change in Clinical Global Impressions-Severity (CGI-S) 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | From Baseline to Week 8 |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Dose-matched placebo tablets, once per day, oral administration | 0 | 171 | 1 | 171 | 63 | 171 |
| EG001 | Vilazodone 15 mg | 15 mg vilazodone tablets, once per day, oral administration | 0 | 175 | 2 | 175 | 81 | 175 |
| EG002 | Vilazodone 30 mg | 30 mg vilazodone tablets, once per day, oral administration | 0 | 180 | 3 | 180 | 97 | 180 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Pilonidal cyst | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area, Head | Allergan | 714-246-4500 | IR-CTRegistration@allergan.com |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069503 | Vilazodone Hydrochloride |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D007211 | Indoles |
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| Withdrawal by Subject |
|
| Protocol Violation |
|
| Lack of Efficacy |
|
| Adverse Event |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Asian |
|
| American Indian or Alaska Native |
|
| Native Hawaiian/Other Pacific Islander |
|
| Other |
|
| Units | Counts |
|---|---|
| Participants |
|
|