A 6-Month Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability, And Efficacy Of DVS SR In The Treatment Of Child And Adolescent Outpatients With MDD
- Conditions
- Major Depressive Disorder
- Interventions
- Drug: DVS SR
- Registration Number
- NCT01371708
- 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
- 283
- Completed study B2061032 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
- Requires precaution against suicide
- Not in generally healthy medical condition
- Poor compliance with study drug or study procedures during participation in study B2061032
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Desvenlafaxine Succinate Sustained-Release DVS SR -
- Primary Outcome Measures
Name Time Method Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.
Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (Combination Group) From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.
- Secondary Outcome Measures
Name Time Method Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission on the CDRS-R was defined as a CDRS-R score \<=28. It was recommended that the CDRS-R be performed prior to the Clinical Global Impression assessments. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases (Combination Group) From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission on the CDRS-R was defined as a CDRS-R score \<=28. It was recommended that the CDRS-R be performed prior to the Clinical Global Impression assessments. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-S, which rates the severity of illness from 1 to 7, and the CGI-Improvement Scale, which assesses improvement in illness since baseline. The CGI-S is a 7-point scale a clinician uses to rate a patient's severity of illness. Scores range from 1 to 7, with 1 indicating "normal, not at all ill" and 7, "among the most extremely ill patients." Higher score on the CGI-S indicates greater severity of illness. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases (Combination Group) From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-S, which rates the severity of illness from 1 to 7, and the CGI-Improvement Scale, which assesses improvement in illness since baseline. The CGI-S is a 7-point scale a clinician uses to rate a patient's severity of illness. Scores range from 1 to 7, with 1 indicating "normal, not at all ill" and 7, "among the most extremely ill patients." Higher score on the CGI-S indicates greater severity of illness. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases (Combination Group) From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group) From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Percentage of Participants With Remission at Week 26, Based on Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 Remission on the CDRS-R was defined as a CDRS-R score \<=28. The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total s cores indicate lower intensity of symptoms.
Percentage of Participants With Remission at Week 26, Based on a Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases (Combination Group) From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 Remission on the CDRS-R was defined as a CDRS-R score \<=28. The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total s cores indicate lower intensity of symptoms.
Trial Locations
- Locations (36)
Biomedica Research Group
🇨🇱Santiago, Region Metropolitana, Chile
Discovery and Wellness Center for Children/University Hospitals Case Medical Center
🇺🇸Cleveland, Ohio, United States
Pharmasite Research, Inc
🇺🇸Baltimore, Maryland, United States
Premier Psychiatric Research Institute, LLC
🇺🇸Lincoln, Nebraska, United States
Neuro-Behavioral Clinical Research, Inc.
🇺🇸Canton, Ohio, United States
Stony Brook University Medical Center, child and Adolescent Psychiatry
🇺🇸Stony Brook, New York, United States
SJS Clinical Research, Inc.
🇺🇸Destin, Florida, United States
Baber Research Group
🇺🇸Naperville, Illinois, United States
MCB Clinical Research Centers
🇺🇸Colorado Springs, Colorado, United States
Northwest Behavioral Research Center
🇺🇸Marietta, Georgia, United States
Sun Valley Research Center
🇺🇸Imperial, California, United States
Capstone Clinical Research
🇺🇸Libertyville, Illinois, United States
Millennium Psychiatric Associates, LLC
🇺🇸Creve Coeur, Missouri, United States
Medical Research Group of Central Florida
🇺🇸Orange City, Florida, United States
Bioscience Research, LLC.
🇺🇸Mount Kisco, New York, United States
Finger Lakes Clinical Research
🇺🇸Rochester, New York, United States
Research Strategies of Memphis, LLC.
🇺🇸Memphis, Tennessee, United States
Clinical Trials of Texas, Inc.
🇺🇸San Antonio, Texas, United States
Clinical Trials of Texas, INC
🇺🇸San Antonio, Texas, United States
The University Of Alabama At Birmingham, Office Of Psychiatric Research
🇺🇸Birmingham, Alabama, United States
Sooner Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
Center for Advanced Improvement
🇺🇸Tucson, Arizona, United States
Institute of Living/Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Clinical Neuroscience Solutions
🇺🇸Jacksonville, Florida, United States
Janus Center for Psychiatric Research
🇺🇸West Palm Beach, Florida, United States
Erie County Medical Center/State University of New York (SUNY) at Buffalo Affiliate
🇺🇸Buffalo, New York, United States
Clinco
🇺🇸Terre Haute, Indiana, United States
The Zucker Hillside Hospital, North Shore-Long Island Jewish Health System
🇺🇸Glen Oaks, New York, United States
Eastside Therapeutic Resource
🇺🇸Kirkland, Washington, United States
Millenia Psychiatry & Research, Inc.
🇺🇸Orlando, Florida, United States
Sarkis Clinical Trials
🇺🇸Gainesville, Florida, United States
Allance Research Group
🇺🇸Richmond, Virginia, United States
Virginia Treatment Center for Children
🇺🇸Richmond, Virginia, United States
Alliance Research Group
🇺🇸Richmond, Virginia, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
FutureSearch Trials
🇺🇸Austin, Texas, United States