- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01371708
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 junio de 2017 actualizado 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).
Descripción general del estudio
Tipo de estudio
Intervencionista
Inscripción (Actual)
283
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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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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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
7 años a 17 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Succinato de desvenlafaxina de liberación sostenida
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Percentage of Participants With a Treatment-emergent Adverse Event (TEAE)
Periodo de tiempo: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
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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)
Periodo de tiempo: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
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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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases
Periodo de tiempo: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
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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.
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From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
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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)
Periodo de tiempo: 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.
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From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
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Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases
Periodo de tiempo: 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.
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From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
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Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases (Combination Group)
Periodo de tiempo: 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.
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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 Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases
Periodo de tiempo: 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.
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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 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)
Periodo de tiempo: 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.
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From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
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Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases
Periodo de tiempo: 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
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Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
2 de febrero de 2012
Finalización primaria (Actual)
22 de abril de 2016
Finalización del estudio (Actual)
22 de abril de 2016
Fechas de registro del estudio
Enviado por primera vez
9 de junio de 2011
Primero enviado que cumplió con los criterios de control de calidad
10 de junio de 2011
Publicado por primera vez (Estimar)
13 de junio de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de julio de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
28 de junio de 2017
Última verificación
1 de junio de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- B2061030
- 3151A6-3344 (Otro identificador: Alias Study Number)
- 2008-001876-67 (Número EudraCT)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre DVS SR
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PfizerTerminado
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Wyeth is now a wholly owned subsidiary of PfizerTerminadoDesorden depresivo | Depresión | Trastorno depresivo mayor
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Wyeth is now a wholly owned subsidiary of PfizerTerminadoMenopausiaBélgica, Finlandia, Suecia, Sudáfrica, Croacia, Reino Unido, Francia, Rumania, Ucrania, España, Polonia, Hungría, República Checa, México, Países Bajos
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Wyeth is now a wholly owned subsidiary of PfizerTerminado
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Wyeth is now a wholly owned subsidiary of PfizerTerminado
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Wyeth is now a wholly owned subsidiary of PfizerTerminadoSofocos | Menopausia | Trastornos del sueño
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Wyeth is now a wholly owned subsidiary of PfizerTerminado
-
Wyeth is now a wholly owned subsidiary of PfizerTerminadoTrastorno depresivo mayor
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Wyeth is now a wholly owned subsidiary of PfizerTerminadoTrastorno depresivo mayor
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Wyeth is now a wholly owned subsidiary of PfizerTerminadoTrastorno depresivo mayor