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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

2017년 6월 28일 업데이트: 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).

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

283

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

7년 (어린이)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Desvenlafaxine Succinate 지속 방출
의약품: DVS SR
Subjects will receive a flexible-dose of 20, 25, 35, or 50 mg/day as prescribed by the investigator

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants With a Treatment-emergent Adverse Event (TEAE)
기간: 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)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: 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)
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Pfizer

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2012년 2월 2일

기본 완료 (실제)

2016년 4월 22일

연구 완료 (실제)

2016년 4월 22일

연구 등록 날짜

최초 제출

2011년 6월 9일

QC 기준을 충족하는 최초 제출

2011년 6월 10일

처음 게시됨 (추정)

2011년 6월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 7월 27일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 6월 28일

마지막으로 확인됨

2017년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • B2061030
  • 3151A6-3344 (기타 식별자: Alias Study Number)
  • 2008-001876-67 (EudraCT 번호)

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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