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
28 juni 2017 uppdaterad av: Pfizer
A 6-month, Open-label, Multi-center, Flexible Dose Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability And Efficacy Of Desvenlafaxine Succinate Sustained Release (Dvs Sr) Tablets In The Treatment Of Children And Adolescent Outpatients With Major Depressive Disorder
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).
Studieöversikt
Studietyp
Interventionell
Inskrivning (Faktisk)
283
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Region Metropolitana
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Santiago, Region Metropolitana, Chile, 7500710
- BioMedica Research Group
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Alabama
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Birmingham, Alabama, Förenta staterna, 35294-0009
- The University of Alabama at Birmingham, Office of Psychiatric Research
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Arizona
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Tucson, Arizona, Förenta staterna, 85719
- Center for Advanced Improvement
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California
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Imperial, California, Förenta staterna, 92251
- Sun Valley Research Center
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Colorado
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Colorado Springs, Colorado, Förenta staterna, 80910
- MCB Clinical Research Centers
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Connecticut
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Hartford, Connecticut, Förenta staterna, 06106
- Institute of Living/Hartford Hospital
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Florida
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Destin, Florida, Förenta staterna, 32541
- SJS Clinical Research, Inc.
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Gainesville, Florida, Förenta staterna, 32607
- Sarkis Clinical Trials
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Jacksonville, Florida, Förenta staterna, 32256
- Clinical Neuroscience Solutions
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Orange City, Florida, Förenta staterna, 32763
- Medical Research Group of Central Florida
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Orlando, Florida, Förenta staterna, 32839
- Millenia Psychiatry & Research, Inc.
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West Palm Beach, Florida, Förenta staterna, 33407
- Janus Center For Psychiatric Research
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Georgia
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Marietta, Georgia, Förenta staterna, 30060
- Northwest Behavioral Research Center
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Illinois
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Libertyville, Illinois, Förenta staterna, 60048
- Capstone Clinical Research
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Naperville, Illinois, Förenta staterna, 60563
- Baber Research Group
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Indiana
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Terre Haute, Indiana, Förenta staterna, 47802
- Clinco
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Maryland
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Baltimore, Maryland, Förenta staterna, 21208
- Pharmasite Research, Inc
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Missouri
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Creve Coeur, Missouri, Förenta staterna, 63141
- Millennium Psychiatric Associates, LLC
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Nebraska
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Lincoln, Nebraska, Förenta staterna, 68526
- Premier Psychiatric Research Institute, LLC
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New York
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Buffalo, New York, Förenta staterna, 14215
- Erie County Medical Center/State University of New York (SUNY) at Buffalo Affiliate
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Glen Oaks, New York, Förenta staterna, 11004
- The Zucker Hillside Hospital, North Shore-Long Island Jewish Health System
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Mount Kisco, New York, Förenta staterna, 10549
- Bioscience Research, LLC.
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Rochester, New York, Förenta staterna, 14618
- Finger Lakes Clinical Research
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Stony Brook, New York, Förenta staterna, 11794-8790
- Stony Brook University Medical Center, Child And Adolescent Psychiatry
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Ohio
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Canton, Ohio, Förenta staterna, 44718
- Neuro-Behavioral Clinical Research, Inc.
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Cleveland, Ohio, Förenta staterna, 44106
- Discovery and Wellness Center for Children/University Hospitals Case Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, Förenta staterna, 73112
- Sooner Clinical Research
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Tennessee
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Memphis, Tennessee, Förenta staterna, 38119
- Research Strategies of Memphis, LLC.
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Texas
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Austin, Texas, Förenta staterna, 78731
- FutureSearch Trials
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San Antonio, Texas, Förenta staterna, 78229
- Clinical Trials of Texas, Inc.
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San Antonio, Texas, Förenta staterna, 78229
- Clinical Trials of Texas, Inc
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Virginia
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Richmond, Virginia, Förenta staterna, 23298
- Virginia Commonwealth University
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Richmond, Virginia, Förenta staterna, 23230
- Alliance Research Group
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Richmond, Virginia, Förenta staterna, 23230
- Allance Research Group
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Richmond, Virginia, Förenta staterna, 23298
- Virginia Treatment Center For Children
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Washington
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Kirkland, Washington, Förenta staterna, 98033
- Eastside Therapeutic Resource
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
7 år till 17 år (Barn)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- 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
Exclusion Criteria:
- Requires precaution against suicide
- Not in generally healthy medical condition
- Poor compliance with study drug or study procedures during participation in study B2061032
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Desvenlafaxinsuccinat fördröjd frisättning
|
Subjects will receive a flexible-dose of 20, 25, 35, or 50 mg/day as prescribed by the investigator
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of Participants With a Treatment-emergent Adverse Event (TEAE)
Tidsram: 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.
|
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
|
|
Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (Combination Group)
Tidsram: 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.
|
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases
Tidsram: 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.
|
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
|
|
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)
Tidsram: 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.
|
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
|
|
Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases
Tidsram: 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.
|
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
|
|
Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases (Combination Group)
Tidsram: 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.
|
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
|
|
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
Tidsram: 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.
|
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
|
|
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)
Tidsram: 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.
|
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
|
|
Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases
Tidsram: 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.
|
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
|
|
Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group)
Tidsram: 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.
|
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
|
|
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
Tidsram: 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.
|
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
|
|
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)
Tidsram: 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.
|
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
|
Samarbetspartners och utredare
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Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
2 februari 2012
Primärt slutförande (Faktisk)
22 april 2016
Avslutad studie (Faktisk)
22 april 2016
Studieregistreringsdatum
Först inskickad
9 juni 2011
Först inskickad som uppfyllde QC-kriterierna
10 juni 2011
Första postat (Uppskatta)
13 juni 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
27 juli 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 juni 2017
Senast verifierad
1 juni 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- B2061030
- 3151A6-3344 (Annan identifierare: Alias Study Number)
- 2008-001876-67 (EudraCT-nummer)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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