Major Depressive Disorder Clinical Trial
— VLZ-MD-22Official title:
A Multicenter, Double-blind, Placebo- and Active-Controlled Parallel-Group Evaluation of the Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder
| Verified date | September 2019 |
| Source | Forest Laboratories |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 473 |
| Est. completion date | September 11, 2018 |
| Est. primary completion date | September 11, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 7 Years to 17 Years |
| Eligibility |
Inclusion Criteria: - Male or Female outpatients between 7-17 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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Okanagan Clinical Trials | Kelowna | British Columbia |
| Canada | Paediatric Sleep Research Inc | Toronto | Ontario |
| United States | Institute for Advanced Medical Research | Alpharetta | Georgia |
| United States | Atlantic Center for Medical Research | Atlanta | Georgia |
| United States | BioBehavioral Research of Austin, PC | Austin | Texas |
| United States | FutureSearch Clinical trials, Inc. | Austin | Texas |
| United States | Haidar Almhana Nieding LLC | Avon Lake | Ohio |
| United States | Hugo W Moser Research Institute at Kennedy Krieger, Inc. | Baltimore | Maryland |
| United States | Pharmsite Research Inc. | Baltimore | Maryland |
| United States | Northwest Clinical Research Center | Bellevue | Washington |
| United States | CITrials - Bellflower | Bellflower | California |
| United States | Alliance Clinical Research | Birmingham | Alabama |
| United States | Neuro-Behavioral Clinical Research, Inc | Canton | Ohio |
| United States | UVA Center for Psychopharmacology Research in Youth | Charlottesville | Virginia |
| United States | University of Cincinnati | Cincinnati | Ohio |
| United States | University Hospitals Cleveland Medical Center, Psychiatry | Cleveland | Ohio |
| United States | Ericksen Research and Development | Clinton | Utah |
| United States | Ohio State Univ. Dept of Psychiatry | Columbus | Ohio |
| United States | ATP Clinical Research | Costa Mesa | California |
| United States | Millennium Psychiatric Associates | Creve Coeur | Missouri |
| United States | University of TX Southwestern Medical Ctr | Dallas | Texas |
| United States | Harmonex Neuroscience Research | Dothan | Alabama |
| United States | Core Clinical Research | Everett | Washington |
| United States | Behavioral Research Specialists, LLC | Glendale | California |
| United States | Hartford Hospital | Hartford | Connecticut |
| United States | Palm Springs Research, LLC | Hialeah | Florida |
| United States | IMIC Inc. | Homestead | Florida |
| United States | Bayou City Research Ltd | Houston | Texas |
| United States | Houston Endoscopy and Research Ctr | Houston | Texas |
| United States | Goldpoint Clinical Research, LLC | Indianapolis | Indiana |
| United States | Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida |
| United States | Osceola Mental Health dba Park Place Behavioral Health Care | Kissimmee | Florida |
| United States | Lake Charles Clinical Trials | Lake Charles | Louisiana |
| United States | Innovative Clinical Research, Inc. | Lauderhill | Florida |
| United States | Capstone Clinical Research | Libertyville | Illinois |
| United States | Woodland International Research Group, INC | Little Rock | Arkansas |
| United States | Northwest Behavioral Research Center | Marietta | Georgia |
| United States | Professional Psychiatric Services | Mason | Ohio |
| United States | Research Strategies of Memphis LLC | Memphis | Tennessee |
| United States | BioScience Research LLC | Mount Kisco | New York |
| United States | Baber Research Group | Naperville | Illinois |
| United States | Manhattan Behavioral Medicine | New York | New York |
| United States | Neuroscience Research Institute Inc. | Oak Park | Illinois |
| United States | Cutting Edge Research Group | Oklahoma City | Oklahoma |
| United States | IPS Research Company | Oklahoma City | Oklahoma |
| United States | Clinical Neuroscience Solutions, Inc. | Orlando | Florida |
| United States | Psychiatric Associates | Overland Park | Kansas |
| United States | Phoenix Children's Hospital | Phoenix | Arizona |
| United States | Research Across America | Plano | Texas |
| United States | Finger Lakes Clinical research | Rochester | New York |
| United States | NeuroScientific Insights | Rockville | Maryland |
| United States | St. Charles Psychiatric Associates - Midwest Research Group | Saint Charles | Missouri |
| United States | Focus and Balance | San Antonio | Texas |
| United States | PCSD - Feighner Research | San Diego | California |
| United States | Baystate Medical Center | Springfield | Massachusetts |
| United States | Richmond Behavioral Associates | Staten Island | New York |
| United States | Family Psychiatry of The Woodlands | The Woodlands | Texas |
| United States | Pacific Clinical Research Medical Group | Upland | California |
| United States | Children's National Medical Center | Washington | District of Columbia |
| United States | Adams Clinical Trials, LLC | Watertown | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Forest Laboratories |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. | 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. | From Baseline to Week 8 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05537558 -
Precision Medicine for the Prediction of Treatment (PROMPT) Response (PROMPT)
|
||
| Terminated |
NCT02192099 -
Open Label Extension for GLYX13-C-202, NCT01684163
|
Phase 2 | |
| Completed |
NCT03142919 -
Lipopolysaccharide (LPS) Challenge in Depression
|
Phase 2 | |
| Recruiting |
NCT05547035 -
Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders
|
N/A | |
| Terminated |
NCT02940769 -
Neurobiological Effects of Light on MDD
|
N/A | |
| Recruiting |
NCT05892744 -
Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression
|
Phase 4 | |
| Recruiting |
NCT05537584 -
SMART Trial to Predict Anhedonia Response to Antidepressant Treatment
|
Phase 4 | |
| Active, not recruiting |
NCT05061706 -
Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
|
Phase 3 | |
| Completed |
NCT04479852 -
A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder
|
Phase 2 | |
| Recruiting |
NCT04032301 -
Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans
|
Phase 1 | |
| Recruiting |
NCT05527951 -
Enhanced Measurement-Based Care Effectiveness for Depression (EMBED) Study
|
N/A | |
| Completed |
NCT03511599 -
Cycloserine rTMS Plasticity Augmentation in Depression
|
Phase 1 | |
| Recruiting |
NCT04392947 -
Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation
|
N/A | |
| Recruiting |
NCT05895747 -
5-HTP and Creatine for Depression R33 Phase
|
Phase 2 | |
| Recruiting |
NCT05273996 -
Predictors of Cognitive Outcomes in Geriatric Depression
|
Phase 4 | |
| Recruiting |
NCT05813093 -
Interleaved TMS-fMRI in Ultra-treatment Resistant Depression
|
N/A | |
| Recruiting |
NCT05135897 -
The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments
|
||
| Enrolling by invitation |
NCT04509102 -
Psychostimulant Augmentation of Repetitive TMS for the Treatment of Major Depressive Disorder
|
Early Phase 1 | |
| Recruiting |
NCT06145594 -
EMA-Guided Maintenance TMS for Depression
|
N/A | |
| Recruiting |
NCT06026917 -
Assessing Dopamine Transporter Occupancy in the Patients With Depression Brain With Toludesvenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET)
|
Phase 4 |