Major Depressive Disorder Clinical Trial
Official title:
A Double-blind, Placebo- and Active-Controlled Evaluation of the Safety and Efficacy of Levomilnacipran ER in Adolescent Patients With Major Depressive Disorder
Verified date | August 2020 |
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 levomilnacipran ER relative to placebo in adolescent outpatients (12-17 years) with Major Depressive Disorder (MDD). In addition, the study is designed to obtain pharmacokinetics (PK) data to guide dose selection for future pediatric studies of levomilnacipran.
Status | Completed |
Enrollment | 552 |
Est. completion date | August 19, 2019 |
Est. primary completion date | August 19, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 17 Years |
Eligibility |
Key Inclusion Criteria: - Male or female outpatients;12-17 years of age - Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for MDD, confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children--Present and Lifetime (K-SADS-PL) - Score = 40 on the Children's Depression Rating Scale-Revised (CDRS-R) at Visits 1 and 2 - Clinical Global Impressions-Severity (CGI-S) score = 4 at Visits 1 and 2 - Reliable caregiver - Physical examination, vital signs, clinical laboratory tests, and electrocardiogram (ECG) normal or not clinically significant Key Psychiatric Exclusion Criteria: - DSM-IV-TR-based diagnosis of an axis I disorder other than MDD that is the primary focus of treatment - Mental retardation or amnestic or other cognitive disorders - Significant suicide risk: - Suicide attempt within the past year OR - Investigator judgment (based on psychiatric interview and Columbia-Suicide Severity Rating Scale (C-SSRS)) Key Treatment-Related Exclusion Criteria: - Allergy, intolerance, or hypersensitivity to levomilnacipran, milnacipran, fluoxetine, or any other selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI) - Use of prohibited concomitant medication that cannot be discontinued Other Key Medical Exclusion Criteria: - Any current medical condition that might interfere with the conduct of the study, confound the interpretation of study results, or affect participants safety - Liver enzyme tests aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2X the upper limit of normal (ULN) - Clinically significant cardiovascular disorders - Seizure disorder or risk of seizure - Drug or alcohol abuse or dependence (within the past year) - Positive urine drug screen or blood alcohol |
Country | Name | City | State |
---|---|---|---|
Puerto Rico | INSPIRA Clinical Research | San Juan | |
United States | Advanced Research Center, Inc. | Anaheim | California |
United States | Atlanta Center for Medical Research | Atlanta | Georgia |
United States | Kentucky Pediatric Research | Bardstown | Kentucky |
United States | Northwest Clinical Research Center | Bellevue | Washington |
United States | Florida Clinical Research Center; LLC | Bradenton | Florida |
United States | UVA Child and Family Psychiatry Clinic | Charlottesville | Virginia |
United States | MCB Clinical Research Center | Colorado Springs | Colorado |
United States | ProScience Research Group | Culver City | California |
United States | Midwest Clinical Research Center | Dayton | Ohio |
United States | Harmonex, Inc | Dothan | Alabama |
United States | Eastside Therapeutic Resource dba Core Clinical | Everett | Washington |
United States | Coastal Clinical Research Specialists | Fernandina Beach | Florida |
United States | Gulfcoast Clinical Research Center | Fort Myers | Florida |
United States | Research in Miami Inc | Hialeah | Florida |
United States | Advanced Research Institute of Miami | Homestead | Florida |
United States | Bay Area Clinical Services dba Earle Research | Houston | Texas |
United States | Red Oak Psychiatry Associates | Houston | Texas |
United States | UTHSC-Houston | Houston | Texas |
United States | Sun Valley Research Center | Imperial | California |
United States | Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida |
United States | Kolade Research Institute | Las Vegas | Nevada |
United States | Innovative Clinical Research, Inc. | Lauderhill | Florida |
United States | Alivation Research | Lincoln | Nebraska |
United States | Alliance for Research | Long Beach | California |
United States | Professional Psychiatric Services | Mason | Ohio |
United States | Sandeep Gaonkar, MD | Naperville | Illinois |
United States | Healthy Perspectives - Innovative Mental Health Services. PLLC | Nashua | New Hampshire |
United States | Manhattan Behavioral Medicine | New York | New York |
United States | Cutting Edge Research Group | Oklahoma City | Oklahoma |
United States | IPS Research Company | Oklahoma City | Oklahoma |
United States | Paradigm Research Professionals | Oklahoma City | Oklahoma |
United States | Sooner Clinical Research | Oklahoma City | Oklahoma |
United States | Medical Research Group of Central Florida | Orange City | Florida |
United States | Clinical Neuroscience Solutions, Inc. | Orlando | Florida |
United States | NeuroMedical Institute | Panama City | Illinois |
United States | Asclepes Research Centers | Panorama City | California |
United States | Princeton Medical Institute | Princeton | New Jersey |
United States | Carilion Medical Center | Roanoke | Virginia |
United States | Oregon Center for Clinical Investigations, Inc. | Salem | Oregon |
United States | Syrentis Clinical Research | Santa Ana | California |
United States | Institute for Behavioral Medicine | Smyrna | Georgia |
United States | Clinical Research Institute | Stockbridge | Georgia |
United States | University of South Florida Board of Trustee | Tampa | Florida |
United States | Family Psychiatry of The Woodlands | The Woodlands | Texas |
United States | University of Arizona Department of Psychiatry | Tucson | Arizona |
United States | Tulsa Clinical Research, LLC | Tulsa | Oklahoma |
United States | Pacific Clinical Research Medical Group | Upland | California |
United States | Adams Clinical Trials, LLC | Watertown | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Forest Laboratories |
United States, Puerto Rico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score | CDRS-R is a 17-item scale measuring presence and severity of symptoms commonly associated with childhood depression and is scored on a 1-to-5- or 1-to-7-point scale. Rating of 1 indicates normal function. The CDRS-R total score ranges from 17 to 113; higher score indicates more severe depression. A negative change from Baseline indicates improvement. Mixed Model for Repeated Measures (MMRM) was used for analysis. | Baseline (Week 0) to Week 8 | |
Secondary | Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale | The CGI-S is a clinician-rated scale used to rate the severity of the participants current state of mental illness compared with MDD population. The participant was rated on a scale from 1 to 7, where 1= Very much improved; 2= Much improved; 3= Minimally improved; 4= No change; 5= Minimally worse; 6= Much worse; 7= Very much worse. Higher score indicates worsening of mental illness. A negative change from Baseline indicates improvement. MMRM was used for analysis. | Baseline (Week 0) to Week 8 |
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