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The purpose of this study is to evaluate the long-term safety and tolerability of vilazodone for the treatment of MDD in pediatric outpatients (7-17 years).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vilazodone | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vilazodone | Drug | Vilazodone tablets, once daily, oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants to Experience a Treatment Emergent Adverse Event (TEAE) | The number of Participants who experienced a treatment emergent adverse events during the 27 week period from screening to the end of the open-label treatment period | Visit 1 (Week -1) to up to Visit 16 (Week 26) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily McCusker, PhD | Forest Research Institute, Inc., 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 |
Patients who completed lead-in study VLZ-MD-22 (NCT02372799) had already completed a down-taper period at the end of study VLZ-MD-22 and were not required to undergo a washout period in VLZ-MD-23. For de novo patients, the screening/washout period was generally 1 week prior to Baseline.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo/Vilazodone | Participants who received placebo during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration. |
| FG001 | Vilazodone/Vilazodone |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Open-Lable Treatment Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 2, 2016 | Jul 23, 2019 |
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| Baseline (Week 0) to Week 26 |
| Change From Baseline in the 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. | Baseline (Week 0) to Week 26 |
| Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) | The Clinical Global Impressions-Improvement is a clinician-rated instrument that was used to rate total improvement or worsening of mental illness, regardless of whether the Investigator considered it to be a result of treatment with the investigational product. The CGI-I was used to rate the patient's improvement on a scale from 1 to 7, with 1 indicating that the patient was very much improved (with a score of 4 indicating no change) and 7 indicating the patient was very much worse. | Baseline (Week 0) to Week 26 |
| 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 | 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 |
| 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 |
| 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 |
| Erie County Medical Center/State University of New York of Buffalo Affiliate | Buffalo | New York | 14215 | 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, Psychiatr | 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 |
| BioBehavioral Research of Austin, PC | Austin | Texas | 78759 | United States |
| UT Health Science Center at Houston | Houston | Texas | 77054 | United States |
| Houston Endoscopy and Research Ctr | Houston | Texas | 77079 | United States |
| Research Across America | Plano | Texas | 75093 | 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 | Kirkland | Washington | 98033 | United States |
| Okanagan Clinical Trials Inc. | Kelowna | British Columbia | V1Y1Z9 | Canada |
| Paediatric Sleep Research Inc | Toronto | Ontario | M6J3S3 | Canada |
Participants who received vilazodone during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
| FG002 | Fluoxetine/Vilazodone | Participants who received Fluoxetine during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration. |
| FG003 | De Novo/Vilazodone | Newly enrolled participants received vilazodone tablets once daily, oral administration. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Down-Taper Period |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo/Vilazodone | Participants who received placebo during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration. |
| BG001 | Vilazodone/Vilazodone | Participants who received vilazodone during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration. |
| BG002 | Fluoxetine/Vilazodone | Participants who received Fluoxetine during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration. |
| BG003 | De Novo/Vilazodone | Newly enrolled participants received vilazodone tablets once daily, oral administration. |
| BG004 | 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 (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Weight | Mean | Standard Deviation | kg |
| ||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
| ||||||||||
| 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 325 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 325 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 | Number of Participants to Experience a Treatment Emergent Adverse Event (TEAE) | The number of Participants who experienced a treatment emergent adverse events during the 27 week period from screening to the end of the open-label treatment period | The Safety Population consisted of the 330 participants who took at least 1 dose of open-label investigational product. | Posted | Count of Participants | Participants | Visit 1 (Week -1) to up to Visit 16 (Week 26) |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the 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 Change From Baseline in the CDRS-R Total Score was assessed in the Intent to Treat study population, comprised of the 325 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of the CDRS-R total score. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Week 0) to Week 26 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the 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 was assessed in the Intent to Treat study population, comprised of the 325 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of the CDRS-R total score. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Week 0) to Week 26 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) | The Clinical Global Impressions-Improvement is a clinician-rated instrument that was used to rate total improvement or worsening of mental illness, regardless of whether the Investigator considered it to be a result of treatment with the investigational product. The CGI-I was used to rate the patient's improvement on a scale from 1 to 7, with 1 indicating that the patient was very much improved (with a score of 4 indicating no change) and 7 indicating the patient was very much worse. | The CGI-I was assessed in the Intent to Treat study population, comprised of the 325 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of the CDRS-R total score. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Week 0) to Week 26 |
|
Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week 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/Vilazodone | Participants who received placebo during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration. | 0 | 122 | 6 | 122 | 79 | 122 |
| EG001 | Vilazodone/Vilazodone | Participants who received vilazodone during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration. | 0 | 131 | 0 | 131 | 81 | 131 |
| EG002 | Fluoxetine/Vilazodone | Participants who received Fluoxetine during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration. | 1 | 65 | 1 | 65 | 41 | 65 |
| EG003 | De Novo/Vilazodone | Newly enrolled participants received vilazodone tablets once daily, oral administration. | 0 | 12 | 0 | 12 | 10 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal ideation | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abnormal behaviour | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Gun Shot Wound | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear Pain | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dysmenorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Amnesia | Nervous system 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 | |
|---|---|---|---|---|
| Armin Szegedi, MD, PhD, Vice President CNS Clinical Development | Allergan | 714-246-4500 | IR-CTRegistration@allergan.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 10, 2016 | Aug 20, 2019 | SAP_001.pdf |
| 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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| OG003 | De Novo/Vilazodone | Newly enrolled participants received vilazodone tablets once daily, oral administration. |
|
|
| OG003 | De Novo/Vilazodone | Newly enrolled participants received vilazodone tablets once daily, oral administration. |
|
|
Participants who received Fluoxetine during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
| OG003 | De Novo/Vilazodone | Newly enrolled participants received vilazodone tablets once daily, oral administration. |
|
|