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 juin 2017 mis à jour par: 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).
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
283
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Region Metropolitana
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Santiago, Region Metropolitana, Chili, 7500710
- BioMedica Research Group
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Alabama
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Birmingham, Alabama, États-Unis, 35294-0009
- The University of Alabama at Birmingham, Office of Psychiatric Research
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Arizona
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Tucson, Arizona, États-Unis, 85719
- Center for Advanced Improvement
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California
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Imperial, California, États-Unis, 92251
- Sun Valley Research Center
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Colorado
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Colorado Springs, Colorado, États-Unis, 80910
- MCB Clinical Research Centers
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Connecticut
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Hartford, Connecticut, États-Unis, 06106
- Institute of Living/Hartford Hospital
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Florida
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Destin, Florida, États-Unis, 32541
- SJS Clinical Research, Inc.
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Gainesville, Florida, États-Unis, 32607
- Sarkis Clinical Trials
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Jacksonville, Florida, États-Unis, 32256
- Clinical Neuroscience Solutions
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Orange City, Florida, États-Unis, 32763
- Medical Research Group of Central Florida
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Orlando, Florida, États-Unis, 32839
- Millenia Psychiatry & Research, Inc.
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West Palm Beach, Florida, États-Unis, 33407
- Janus Center For Psychiatric Research
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Georgia
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Marietta, Georgia, États-Unis, 30060
- Northwest Behavioral Research Center
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Illinois
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Libertyville, Illinois, États-Unis, 60048
- Capstone Clinical Research
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Naperville, Illinois, États-Unis, 60563
- Baber Research Group
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Indiana
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Terre Haute, Indiana, États-Unis, 47802
- Clinco
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Maryland
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Baltimore, Maryland, États-Unis, 21208
- Pharmasite Research, Inc
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Missouri
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Creve Coeur, Missouri, États-Unis, 63141
- Millennium Psychiatric Associates, LLC
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Nebraska
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Lincoln, Nebraska, États-Unis, 68526
- Premier Psychiatric Research Institute, LLC
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New York
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Buffalo, New York, États-Unis, 14215
- Erie County Medical Center/State University of New York (SUNY) at Buffalo Affiliate
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Glen Oaks, New York, États-Unis, 11004
- The Zucker Hillside Hospital, North Shore-Long Island Jewish Health System
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Mount Kisco, New York, États-Unis, 10549
- Bioscience Research, LLC.
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Rochester, New York, États-Unis, 14618
- Finger Lakes Clinical Research
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Stony Brook, New York, États-Unis, 11794-8790
- Stony Brook University Medical Center, Child And Adolescent Psychiatry
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Ohio
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Canton, Ohio, États-Unis, 44718
- Neuro-Behavioral Clinical Research, Inc.
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Cleveland, Ohio, États-Unis, 44106
- Discovery and Wellness Center for Children/University Hospitals Case Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis, 73112
- Sooner Clinical Research
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Tennessee
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Memphis, Tennessee, États-Unis, 38119
- Research Strategies of Memphis, LLC.
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Texas
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Austin, Texas, États-Unis, 78731
- FutureSearch Trials
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San Antonio, Texas, États-Unis, 78229
- Clinical Trials of Texas, Inc.
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San Antonio, Texas, États-Unis, 78229
- Clinical Trials of Texas, Inc
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Virginia
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Richmond, Virginia, États-Unis, 23298
- Virginia Commonwealth University
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Richmond, Virginia, États-Unis, 23230
- Alliance Research Group
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Richmond, Virginia, États-Unis, 23230
- Allance Research Group
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Richmond, Virginia, États-Unis, 23298
- Virginia Treatment Center For Children
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Washington
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Kirkland, Washington, États-Unis, 98033
- Eastside Therapeutic Resource
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
7 ans à 17 ans (Enfant)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Succinate de desvenlafaxine à libération prolongée
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage of Participants With a Treatment-emergent Adverse Event (TEAE)
Délai: 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
|
|
Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (Combination Group)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
2 février 2012
Achèvement primaire (Réel)
22 avril 2016
Achèvement de l'étude (Réel)
22 avril 2016
Dates d'inscription aux études
Première soumission
9 juin 2011
Première soumission répondant aux critères de contrôle qualité
10 juin 2011
Première publication (Estimation)
13 juin 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
27 juillet 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
28 juin 2017
Dernière vérification
1 juin 2017
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- B2061030
- 3151A6-3344 (Autre identifiant: Alias Study Number)
- 2008-001876-67 (Numéro EudraCT)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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