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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 czerwca 2017 zaktualizowane przez: 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).

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

283

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Chile
    • Region Metropolitana
      • Santiago, Region Metropolitana, Chile, 7500710
        • BioMedica Research Group
  • Stany Zjednoczone
    • Alabama
      • Birmingham, Alabama, Stany Zjednoczone, 35294-0009
        • The University of Alabama at Birmingham, Office of Psychiatric Research
    • Arizona
      • Tucson, Arizona, Stany Zjednoczone, 85719
        • Center for Advanced Improvement
    • California
      • Imperial, California, Stany Zjednoczone, 92251
        • Sun Valley Research Center
    • Colorado
      • Colorado Springs, Colorado, Stany Zjednoczone, 80910
        • MCB Clinical Research Centers
    • Connecticut
      • Hartford, Connecticut, Stany Zjednoczone, 06106
        • Institute of Living/Hartford Hospital
    • Florida
      • Destin, Florida, Stany Zjednoczone, 32541
        • SJS Clinical Research, Inc.
      • Gainesville, Florida, Stany Zjednoczone, 32607
        • Sarkis Clinical Trials
      • Jacksonville, Florida, Stany Zjednoczone, 32256
        • Clinical Neuroscience Solutions
      • Orange City, Florida, Stany Zjednoczone, 32763
        • Medical Research Group of Central Florida
      • Orlando, Florida, Stany Zjednoczone, 32839
        • Millenia Psychiatry & Research, Inc.
      • West Palm Beach, Florida, Stany Zjednoczone, 33407
        • Janus Center For Psychiatric Research
    • Georgia
      • Marietta, Georgia, Stany Zjednoczone, 30060
        • Northwest Behavioral Research Center
    • Illinois
      • Libertyville, Illinois, Stany Zjednoczone, 60048
        • Capstone Clinical Research
      • Naperville, Illinois, Stany Zjednoczone, 60563
        • Baber Research Group
    • Indiana
      • Terre Haute, Indiana, Stany Zjednoczone, 47802
        • Clinco
    • Maryland
      • Baltimore, Maryland, Stany Zjednoczone, 21208
        • Pharmasite Research, Inc
    • Missouri
      • Creve Coeur, Missouri, Stany Zjednoczone, 63141
        • Millennium Psychiatric Associates, LLC
    • Nebraska
      • Lincoln, Nebraska, Stany Zjednoczone, 68526
        • Premier Psychiatric Research Institute, LLC
    • New York
      • Buffalo, New York, Stany Zjednoczone, 14215
        • Erie County Medical Center/State University of New York (SUNY) at Buffalo Affiliate
      • Glen Oaks, New York, Stany Zjednoczone, 11004
        • The Zucker Hillside Hospital, North Shore-Long Island Jewish Health System
      • Mount Kisco, New York, Stany Zjednoczone, 10549
        • Bioscience Research, LLC.
      • Rochester, New York, Stany Zjednoczone, 14618
        • Finger Lakes Clinical Research
      • Stony Brook, New York, Stany Zjednoczone, 11794-8790
        • Stony Brook University Medical Center, Child And Adolescent Psychiatry
    • Ohio
      • Canton, Ohio, Stany Zjednoczone, 44718
        • Neuro-Behavioral Clinical Research, Inc.
      • Cleveland, Ohio, Stany Zjednoczone, 44106
        • Discovery and Wellness Center for Children/University Hospitals Case Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, Stany Zjednoczone, 73112
        • Sooner Clinical Research
    • Tennessee
      • Memphis, Tennessee, Stany Zjednoczone, 38119
        • Research Strategies of Memphis, LLC.
    • Texas
      • Austin, Texas, Stany Zjednoczone, 78731
        • FutureSearch Trials
      • San Antonio, Texas, Stany Zjednoczone, 78229
        • Clinical Trials of Texas, Inc.
      • San Antonio, Texas, Stany Zjednoczone, 78229
        • Clinical Trials of Texas, Inc
    • Virginia
      • Richmond, Virginia, Stany Zjednoczone, 23298
        • Virginia Commonwealth University
      • Richmond, Virginia, Stany Zjednoczone, 23230
        • Alliance Research Group
      • Richmond, Virginia, Stany Zjednoczone, 23230
        • Allance Research Group
      • Richmond, Virginia, Stany Zjednoczone, 23298
        • Virginia Treatment Center For Children
    • Washington
      • Kirkland, Washington, Stany Zjednoczone, 98033
        • Eastside Therapeutic Resource

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

7 lat do 17 lat (Dziecko)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Bursztynian deswenlafaksyny o przedłużonym uwalnianiu
Lek: DVS SR
Subjects will receive a flexible-dose of 20, 25, 35, or 50 mg/day as prescribed by the investigator

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Percentage of Participants With a Treatment-emergent Adverse Event (TEAE)
Ramy czasowe: 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)
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Pfizer

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

2 lutego 2012

Zakończenie podstawowe (Rzeczywisty)

22 kwietnia 2016

Ukończenie studiów (Rzeczywisty)

22 kwietnia 2016

Daty rejestracji na studia

Pierwszy przesłany

9 czerwca 2011

Pierwszy przesłany, który spełnia kryteria kontroli jakości

10 czerwca 2011

Pierwszy wysłany (Oszacować)

13 czerwca 2011

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

27 lipca 2017

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

28 czerwca 2017

Ostatnia weryfikacja

1 czerwca 2017

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • B2061030
  • 3151A6-3344 (Inny identyfikator: Alias Study Number)
  • 2008-001876-67 (Numer EudraCT)

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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