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 de junho de 2017 atualizado por: 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).
Visão geral do estudo
Tipo de estudo
Intervencional
Inscrição (Real)
283
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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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, Estados Unidos, 35294-0009
- The University of Alabama at Birmingham, Office of Psychiatric Research
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Arizona
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Tucson, Arizona, Estados Unidos, 85719
- Center for Advanced Improvement
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California
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Imperial, California, Estados Unidos, 92251
- Sun Valley Research Center
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Colorado
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Colorado Springs, Colorado, Estados Unidos, 80910
- MCB Clinical Research Centers
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Connecticut
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Hartford, Connecticut, Estados Unidos, 06106
- Institute of Living/Hartford Hospital
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Florida
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Destin, Florida, Estados Unidos, 32541
- SJS Clinical Research, Inc.
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Gainesville, Florida, Estados Unidos, 32607
- Sarkis Clinical Trials
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Jacksonville, Florida, Estados Unidos, 32256
- Clinical Neuroscience Solutions
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Orange City, Florida, Estados Unidos, 32763
- Medical Research Group of Central Florida
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Orlando, Florida, Estados Unidos, 32839
- Millenia Psychiatry & Research, Inc.
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West Palm Beach, Florida, Estados Unidos, 33407
- Janus Center For Psychiatric Research
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Georgia
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Marietta, Georgia, Estados Unidos, 30060
- Northwest Behavioral Research Center
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Illinois
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Libertyville, Illinois, Estados Unidos, 60048
- Capstone Clinical Research
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Naperville, Illinois, Estados Unidos, 60563
- Baber Research Group
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Indiana
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Terre Haute, Indiana, Estados Unidos, 47802
- Clinco
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Maryland
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Baltimore, Maryland, Estados Unidos, 21208
- Pharmasite Research, Inc
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Missouri
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Creve Coeur, Missouri, Estados Unidos, 63141
- Millennium Psychiatric Associates, LLC
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Nebraska
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Lincoln, Nebraska, Estados Unidos, 68526
- Premier Psychiatric Research Institute, LLC
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New York
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Buffalo, New York, Estados Unidos, 14215
- Erie County Medical Center/State University of New York (SUNY) at Buffalo Affiliate
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Glen Oaks, New York, Estados Unidos, 11004
- The Zucker Hillside Hospital, North Shore-Long Island Jewish Health System
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Mount Kisco, New York, Estados Unidos, 10549
- Bioscience Research, LLC.
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Rochester, New York, Estados Unidos, 14618
- Finger Lakes Clinical Research
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Stony Brook, New York, Estados Unidos, 11794-8790
- Stony Brook University Medical Center, Child And Adolescent Psychiatry
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Ohio
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Canton, Ohio, Estados Unidos, 44718
- Neuro-Behavioral Clinical Research, Inc.
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Cleveland, Ohio, Estados Unidos, 44106
- Discovery and Wellness Center for Children/University Hospitals Case Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73112
- Sooner Clinical Research
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Tennessee
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Memphis, Tennessee, Estados Unidos, 38119
- Research Strategies of Memphis, LLC.
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Texas
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Austin, Texas, Estados Unidos, 78731
- FutureSearch Trials
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San Antonio, Texas, Estados Unidos, 78229
- Clinical Trials of Texas, Inc.
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San Antonio, Texas, Estados Unidos, 78229
- Clinical Trials of Texas, Inc
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Virginia
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Richmond, Virginia, Estados Unidos, 23298
- Virginia Commonwealth University
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Richmond, Virginia, Estados Unidos, 23230
- Alliance Research Group
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Richmond, Virginia, Estados Unidos, 23230
- Allance Research Group
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Richmond, Virginia, Estados Unidos, 23298
- Virginia Treatment Center For Children
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Washington
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Kirkland, Washington, Estados Unidos, 98033
- Eastside Therapeutic Resource
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
7 anos a 17 anos (Filho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Succinato de Desvenlafaxina de Liberação Sustentada
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Subjects will receive a flexible-dose of 20, 25, 35, or 50 mg/day as prescribed by the investigator
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of Participants With a Treatment-emergent Adverse Event (TEAE)
Prazo: 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.
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From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
|
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Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (Combination Group)
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
|
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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)
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
2 de fevereiro de 2012
Conclusão Primária (Real)
22 de abril de 2016
Conclusão do estudo (Real)
22 de abril de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
9 de junho de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
10 de junho de 2011
Primeira postagem (Estimativa)
13 de junho de 2011
Atualizações de registro de estudo
Última Atualização Postada (Real)
27 de julho de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
28 de junho de 2017
Última verificação
1 de junho de 2017
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- B2061030
- 3151A6-3344 (Outro identificador: Alias Study Number)
- 2008-001876-67 (Número EudraCT)
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .