A 6-Month Open-Label Extension Study to the B2061014 Study to Evaluate the Safety, Tolerability and Efficacy of DVS SR in the Treatment of Children and Adolescents With MDD
- Conditions
- Major Depressive Disorder
- Interventions
- Drug: DVS SR
- Registration Number
- NCT01371721
- Lead Sponsor
- Pfizer
- Brief Summary
This is a 6-month, open-label, flexible-dose study evaluating desvenlafaxine succinate sustained release (DVS SR) in the treatment of child and adolescent outpatients with major depressive disorder (MDD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 269
- Completed study B2061014 and who in the investigator's opinion would benefit from long term treatment with DVS SR
- Willingness and ability to comply with scheduled visits, treatment plan and procedures
- Subject requires precaution against suicide
- Subject not in a generally healthy condition
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Desvenlafaxine Succinate Sustained-Release DVS SR -
- Primary Outcome Measures
Name Time Method Percentage of Participants Experiencing a Treatment Emergent Adverse Event Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Remission as Determined by a CDRS-R Score of ≤28 at Week 26 Based on Observed Cases Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study 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.
Change From Baseline at Week 26 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score Based on Observed Cases Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study 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.
Change From Baseline at Week 26 in the Clinical Global Impression of Severity (CGI-S) Score Based on Observed Cases Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study 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 Week 26 Based on Observed Cases Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study 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 Clinical Global Impression, Improvement (CGI-I) Response Defined as a Score of 'Very Much Improved' or 'Much Improved' at Week 26 Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
Trial Locations
- Locations (34)
Dedicated Clinical Research
🇺🇸Goodyear, Arizona, United States
Harmonex Neuroscience Research, Inc.
🇺🇸Dothan, Alabama, United States
Amedica Research Institute, Incorporated
🇺🇸Hialeah, Florida, United States
Rogers Center for Research and Training, Incorporated
🇺🇸Milwaukee, Wisconsin, United States
Behavioral Research Specialists, LLC
🇺🇸Glendale, California, United States
Pacific Clinical Research Medical Group
🇺🇸Orange, California, United States
Hospital Aranda de la Parra, S.A. de C.V.
🇲🇽Leon, Guanajuato, Mexico
Elite Clinical Trials, Incorporated
🇺🇸Wildomar, California, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Memphis, Tennessee, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
ATP Clinical Research, Incorporated
🇺🇸Costa Mesa, California, United States
Summit Research Network (Oregon), Incorporated
🇺🇸Portland, Oregon, United States
Neuropsychiatric Research Center of Orange County
🇺🇸Orange, California, United States
Kolin Research Group
🇺🇸Winter Park, Florida, United States
CIT-Neuropsique, S.C.
🇲🇽Monterrey, Nuevo Leon, Mexico
Center for Psychiatry and Behavioral Medicine, Incorporated
🇺🇸Las Vegas, Nevada, United States
Cutting Edge Research Group
🇺🇸Oklahoma City, Oklahoma, United States
Focus & Balance, LLC
🇺🇸San Antonio, Texas, United States
Summit Research Network (Seattle) LLC
🇺🇸Seattle, Washington, United States
Paradigm Research Professionals, LLC
🇺🇸Oklahoma City, Oklahoma, United States
Synergy Clinical Research Center
🇺🇸National City, California, United States
Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
🇺🇸Little Rock, Arkansas, United States
University of Arizona College of Medicine Dept of Psychiatry
🇺🇸Tucson, Arizona, United States
University of Arizona Clinical and Translational Science Center (CATS)
🇺🇸Tucson, Arizona, United States
North Star Medical Research, LLC
🇺🇸Middleburg Heights, Ohio, United States
Precise Research Centers
🇺🇸Flowood, Mississippi, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
Lake Charles Clinical Trials,
🇺🇸Lake Charles, Louisiana, United States
Psychiatric Associates
🇺🇸Overland Park, Kansas, United States
IPS Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Institute for Behavioral Medicine, LLC
🇺🇸Smyrna, Georgia, United States
St. Charles Psychiatric Associates - Midwest Research Group
🇺🇸St. Charles, Missouri, United States
Grayline Clinical Drug Trials
🇺🇸Witchita Falls, Texas, United States