Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone compared with placebo in pediatric outpatients (7-17 years of age) with major depressive disorder.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vilazodone | Experimental | Vilazodone tablets, 5mg, 10mg and 20mg. Oral administration, once per day. |
|
| Placebo | Placebo Comparator | Dose-matched placebo tablets or capsules, oral administration, once per day. |
|
| Fluoxetine | Active Comparator | Fluoxetine capsules, 10mg and 20 mg. Oral administration, once per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vilazodone | Drug |
|
| |
| Placebo |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Emily McCusker, PhD | Forest Research Institute, an affiliate of Allergan plc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alliance Clinical Research | Birmingham | Alabama | 35213 | United States | ||
| Harmonex Neuroscience Research |
Randomization and treatment assignment were based on a randomization scheme prepared by Allergan Biostatistics prior to the start of the study
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Dose-matched placebo tablets or capsules, oral administration, once per day. |
| FG001 | Vilazodone | Vilazodone tablets 15-30 mg. Oral administration, once per day. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 15, 2015 | Sep 11, 2019 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| Fluoxetine | Drug |
|
|
| From Baseline to Week 8 |
| Dothan |
| Alabama |
| 36303 |
| United States |
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | United States |
| Woodland International Research Group, INC | Little Rock | Arkansas | 72211 | United States |
| CITrials - Bellflower | Bellflower | California | 90706 | United States |
| ATP Clinical Research | Costa Mesa | California | 92626 | United States |
| Behavioral Research Specialists, LLC | Glendale | California | 91206 | United States |
| PCSD - Feighner Research | San Diego | California | 92108 | United States |
| Pacific Clinical Research Medical Group | Upland | California | 91786 | United States |
| Hartford Hospital | Hartford | Connecticut | 06106 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| Palm Springs Research, LLC | Hialeah | Florida | 33012 | United States |
| IMIC Inc. | Homestead | Florida | 33030 | United States |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32256 | United States |
| Osceola Mental Health dba Park Place Behavioral Health Care | Kissimmee | Florida | 34741 | United States |
| Innovative Clinical Research, Inc. | Lauderhill | Florida | 33319 | United States |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32801 | United States |
| Institute for Advanced Medical Research | Alpharetta | Georgia | 30005 | United States |
| Atlantic Center for Medical Research | Atlanta | Georgia | 30331 | United States |
| Northwest Behavioral Research Center | Marietta | Georgia | 30060 | United States |
| Capstone Clinical Research | Libertyville | Illinois | 60048 | United States |
| Baber Research Group | Naperville | Illinois | 60563 | United States |
| Neuroscience Research Institute Inc. | Oak Park | Illinois | 60301 | United States |
| Goldpoint Clinical Research, LLC | Indianapolis | Indiana | 46260 | United States |
| Psychiatric Associates | Overland Park | Kansas | 66211 | United States |
| Lake Charles Clinical Trials | Lake Charles | Louisiana | 70629 | United States |
| Hugo W Moser Research Institute at Kennedy Krieger, Inc. | Baltimore | Maryland | 21205 | United States |
| Pharmsite Research Inc. | Baltimore | Maryland | 21208 | United States |
| NeuroScientific Insights | Rockville | Maryland | 20852 | United States |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | United States |
| Adams Clinical Trials, LLC | Watertown | Massachusetts | 02472 | United States |
| Millennium Psychiatric Associates | Creve Coeur | Missouri | 63141 | United States |
| St. Charles Psychiatric Associates - Midwest Research Group | Saint Charles | Missouri | 63304 | United States |
| BioScience Research LLC | Mount Kisco | New York | 10549 | United States |
| Manhattan Behavioral Medicine | New York | New York | 10022 | United States |
| Finger Lakes Clinical research | Rochester | New York | 14618 | United States |
| Richmond Behavioral Associates | Staten Island | New York | 10312 | United States |
| Haidar Almhana Nieding LLC | Avon Lake | Ohio | 44012 | United States |
| Neuro-Behavioral Clinical Research, Inc | Canton | Ohio | 44718 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45219 | United States |
| University Hospitals Cleveland Medical Center, Psychiatry | Cleveland | Ohio | 44106 | United States |
| Ohio State Univ. Dept of Psychiatry | Columbus | Ohio | 43210 | United States |
| Professional Psychiatric Services | Mason | Ohio | 45040 | United States |
| IPS Research Company | Oklahoma City | Oklahoma | 73103 | United States |
| Cutting Edge Research Group | Oklahoma City | Oklahoma | 73116 | United States |
| Research Strategies of Memphis LLC | Memphis | Tennessee | 38119 | United States |
| FutureSearch Clinical trials, Inc. | Austin | Texas | 78731 | United States |
| BioBehavioral Research of Austin, PC | Austin | Texas | 78759 | United States |
| University of TX Southwestern Medical Ctr | Dallas | Texas | 75235 | United States |
| Bayou City Research Ltd | Houston | Texas | 77007 | United States |
| Houston Endoscopy and Research Ctr | Houston | Texas | 77079 | United States |
| Research Across America | Plano | Texas | 75234 | United States |
| Focus and Balance | San Antonio | Texas | 78229 | United States |
| Family Psychiatry of The Woodlands | The Woodlands | Texas | 77381 | United States |
| Ericksen Research and Development | Clinton | Utah | 84015 | United States |
| UVA Center for Psychopharmacology Research in Youth | Charlottesville | Virginia | 22903 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| Core Clinical Research | Everett | Washington | 98033 | United States |
| Okanagan Clinical Trials | Kelowna | British Columbia | V1Y 1Z9 | Canada |
| Paediatric Sleep Research Inc | Toronto | Ontario | M5B 1T8 | Canada |
| FG002 | Fluoxetine | Fluoxetine capsules 20 mg. Oral administration, once per day. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Down-taper Period |
|
|
The Safety Population will consist of all patients in the Randomized Population who received at least 1 dose of double-blind investigational product.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Dose-matched placebo tablets or capsules, oral administration, once per day. |
| BG001 | Vilazodone | Vilazodone tablets 15-30 mg. Oral administration, once per day. |
| BG002 | Fluoxetine | Fluoxetine capsules 20 mg. Oral administration, once per day. |
| 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 |
| ||||||||||
| Age, Customized | Count of Participants | Participants |
| |||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||
| Weight | Mean | Standard Deviation | kg |
| ||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
| ||||||||||
| 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 CDRS-R total score is provided at baseline for the Intent to Treat study population, which comprises the 465 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of the CDRS-R total score. | Mean | Standard Deviation | units on a scale |
| ||||||||
| 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 CGI-S score is provided at baseline for the Intent to Treat study population, which comprises the 465 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of the CDRS-R total score. | Mean | Standard Deviation | Units on a Scale |
|
| 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 from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.
Not provided
Not provided
| 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 or capsules, oral administration, once per day. | 0 | 186 | 1 | 186 | 54 | 186 |
| EG001 | Vilazodone | Vilazodone tablets 15-30 mg. Oral administration, once per day. | 0 | 187 | 0 | 187 | 97 | 187 |
| EG002 | Fluoxetine | Fluoxetine capsules 20 mg. Oral administration, once per day. | 0 | 97 | 6 | 97 | 27 | 97 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Croup infectious | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Depressive symptom | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hallucination, auditory | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 21.0 | 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 |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 5, 2018 | Sep 11, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069503 | Vilazodone Hydrochloride |
| D005473 | Fluoxetine |
| 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 |
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
Not provided
Not provided
|
|
|
|
|
|
|
|
|
| LSMD |
| -2.39 |
| 2-Sided |
| 95 |
| -5.60 |
| 0.81 |
| Superiority |
| Units | Counts |
|---|---|
| Participants |
|
|
|