A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD
- Conditions
- Major Depressive Disorder
- Interventions
- Registration Number
- NCT01372150
- Lead Sponsor
- Pfizer
- Brief Summary
This is a Double-blind Study Evaluating Desvenlafaxine Succinate (DVS SR) Sustained Release vs Placebo in the Treatment of Children and Adolescent Outpatients with Major Depressive Disorder (MDD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 340
- Age >=7 and <18 years of age
- Primary diagnosis of major depressive disorder (MDD)
- CDRS-R score >40
- History of suicidal behaviour, or requires precaution against suicide
- Not in generally healthy medical condition
- History of psychosis or bipolar disorder
- Seizure disorder
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DVS SR desvenlafaxine succinate sustained release - Fluoxetine fluoxetine Active control for assay sensitivity Placebo placebo -
- Primary Outcome Measures
Name Time Method Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score Baseline and Week 8 Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Adjusted mean presented.
- Secondary Outcome Measures
Name Time Method Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score Baseline and Week 8 A 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline. Adjusted mean presented.
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 Baseline and Weeks 1, 2, 3, 4, 6, and 8 A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved' Weeks 1, 2, 3, 4, 6, and 8 A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Trial Locations
- Locations (43)
Winter Park Memorial Hospital
🇺🇸Winter Park, Florida, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
CIT - Neuropsique, S.C.
🇲🇽Monterrey, Nuevo LEON, Mexico
Psychiatric Associates
🇺🇸Overland Park, Kansas, United States
Center for Psychiatry and Behavioral Medicine, Incorporated
🇺🇸Las Vegas, Nevada, United States
North Star Medical Research, LLC
🇺🇸Middleburg Heights, Ohio, United States
Midwest Research Group
🇺🇸Saint Charles, Missouri, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Orlando, Florida, United States
Precise Research Centers
🇺🇸Flowood, Mississippi, United States
Pacific Clinical Research Medical Group
🇺🇸Orange, California, United States
Neuropsychiatric Research Center of Orange County
🇺🇸Orange, California, United States
Dedicated Clinical Research
🇺🇸Goodyear, Arizona, United States
Kolin Research Group
🇺🇸Winter Park, Florida, United States
Behavioral Research Specialists, LLC
🇺🇸Glendale, California, United States
Creighton University
🇺🇸Omaha, Nebraska, United States
Paradigm Research Professionals, LLC
🇺🇸Oklahoma City, Oklahoma, United States
Focus & Balance, LLC
🇺🇸San Antonio, Texas, United States
Clinical Neuroscience Solutions, Inc
🇺🇸Memphis, Tennessee, United States
Cincinnati Children's Hospital Medical Center (New)
🇺🇸Cincinnati, Ohio, United States
Summit Research Network (Oregon), Incorporated
🇺🇸Portland, Oregon, United States
Heartland Pharma Developments
🇺🇸North Platte, Nebraska, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Hospital Aranda de la Parra S.A. de C.V.
🇲🇽Leon, Guanajuato, Mexico
IPS Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Cutting Edge Research Group
🇺🇸Oklahoma City, Oklahoma, United States
Sharp Mesa Vista Hospital
🇺🇸San Diego, California, United States
Elite Clinical Trials, Incorporated
🇺🇸Wildomar, California, United States
Institute for Behavioral Medicine
🇺🇸Smyrna, Georgia, United States
Synergy Clinical Research Center
🇺🇸National City, California, United States
Harmonex Neuroscience Research, Inc.
🇺🇸Dothan, Alabama, United States
Amedica Research Institute, Incorporated
🇺🇸Hialeah, Florida, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
ATP Clinical Research, Inc. 1
🇺🇸Costa Mesa, California, United States
University of Arizona Clinical and Translational Science Center (CATS)
🇺🇸Tucson, Arizona, United States
University of Arizona College of Medicine Dept of Psychiatry
🇺🇸Tucson, Arizona, United States
Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
🇺🇸Little Rock, Arkansas, United States
St. Charles Psychiatric Associates - Midwest Research Group
🇺🇸Saint Charles, Missouri, United States
Nina F. Wimpie, MD Pediatrics
🇺🇸Middleburg Heights, Ohio, United States
Lake Charles Clinical Trials,
🇺🇸Lake Charles, Louisiana, United States
Neuroscientific Insights
🇺🇸Rockville, Maryland, United States
Rogers Center For Research And Training
🇺🇸Milwaukee, Wisconsin, United States
Summit Research Network (Seattle) LLC
🇺🇸Seattle, Washington, United States
Grayline Clinical Drug Trials
🇺🇸Wichita Falls, Texas, United States