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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. Juni 2017 aktualisiert von: 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).

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

283

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

7 Jahre bis 17 Jahre (Kind)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Desvenlafaxin-Succinat mit verzögerter Freisetzung
Arzneimittel: DVS SR
Subjects will receive a flexible-dose of 20, 25, 35, or 50 mg/day as prescribed by the investigator

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants With a Treatment-emergent Adverse Event (TEAE)
Zeitfenster: 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)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Pfizer

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

2. Februar 2012

Primärer Abschluss (Tatsächlich)

22. April 2016

Studienabschluss (Tatsächlich)

22. April 2016

Studienanmeldedaten

Zuerst eingereicht

9. Juni 2011

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. Juni 2011

Zuerst gepostet (Schätzen)

13. Juni 2011

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

27. Juli 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. Juni 2017

Zuletzt verifiziert

1. Juni 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • B2061030
  • 3151A6-3344 (Andere Kennung: Alias Study Number)
  • 2008-001876-67 (EudraCT-Nummer)

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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