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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

keskiviikko 28. kesäkuuta 2017 päivittänyt: 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).

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

283

Vaihe

  • Vaihe 3

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

7 vuotta - 17 vuotta (Lapsi)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Ei käytössä
  • Inventiomalli: Yksittäinen ryhmätehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: Desvenlafaksiinisukkinaatti pitkävaikutteinen
Lääke: DVS SR
Subjects will receive a flexible-dose of 20, 25, 35, or 50 mg/day as prescribed by the investigator

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Percentage of Participants With a Treatment-emergent Adverse Event (TEAE)
Aikaikkuna: 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)
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Pfizer

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Yleiset julkaisut

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Torstai 2. helmikuuta 2012

Ensisijainen valmistuminen (Todellinen)

Perjantai 22. huhtikuuta 2016

Opintojen valmistuminen (Todellinen)

Perjantai 22. huhtikuuta 2016

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Torstai 9. kesäkuuta 2011

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Perjantai 10. kesäkuuta 2011

Ensimmäinen Lähetetty (Arvio)

Maanantai 13. kesäkuuta 2011

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Torstai 27. heinäkuuta 2017

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Keskiviikko 28. kesäkuuta 2017

Viimeksi vahvistettu

Torstai 1. kesäkuuta 2017

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • B2061030
  • 3151A6-3344 (Muu tunniste: Alias Study Number)
  • 2008-001876-67 (EudraCT-numero)

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Joo

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

Kliiniset tutkimukset Masennustila

Kliiniset tutkimukset DVS SR

Hae vastaavia kokeiluja

Sponsorit ja yhteistyökumppanit

Sairaudet

Huumeiden interventiot

CROs by country

CROs in Croatia

Ehdot

Harvinaiset sairaudet

Huumeiden interventiot

Ravintolisät

Sponsori / yhteistyökumppanit

Sijainnit

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