1/2-MC4R 유전자형과 소아 항정신병 약물로 인한 체중 증가
2016년 1월 6일 업데이트: Anil K. Malhotra, Northwell Health
우리는 13~18세의 어린이와 청소년을 대상으로 일반 치료(UC) 항정신병 치료(아리피프라졸, 퀘티아핀, 리스페리돈)와 지프라시돈(ZIP)을 비교하는 12주 무작위 공개 라벨 연구를 수행할 예정입니다.
환자는 일생 동안 10일 이하의 항정신병 약물에 노출될 것이며 항정신병 약물 사용에 대한 FDA 적응증이 있는 소아 정신 장애(즉, 양극성 조증, 정신분열증 스펙트럼 장애 및 자폐 장애와 관련된 과민성)에 대한 항정신병 치료가 임상적으로 필요합니다.
또한 심각한 기분 조절 장애(SMD)에 대한 연구 진단 기준을 충족하는 청소년도 포함할 것입니다.
무작위배정은 MC4R 유전자형을 기반으로 항정신병제에 의한 체중 증가의 유전적 위험이 높은 대 낮은 것으로 계층화되며, 1차 결과는 두 유전자형 그룹 각각에서 ZIP과 UC 항정신병 치료 사이의 기준선에서 종점까지의 체중 변화입니다.
아래에 설명된 바와 같이, 다른 대사 및 심장 안전 매개변수도 각 유전자형 그룹의 치료 전반에 걸쳐 측정 및 비교됩니다.
연구 개요
상태
종료됨
개입 / 치료
연구 유형
중재적
등록 (실제)
14
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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New York
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Glen Oaks, New York, 미국, 11004
- Zucker Hillside Hospital, Psychiatry Research
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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
13년 (어린이, 성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
포함 기준:
- 13-18세
- 영어로 말하기
- 각각의 소아 또는 성인 연령 그룹에서 적어도 하나의 약제에 대한 SGA 사용에 대한 FDA 적응증이 있는 DSM 진단. 구체적으로, 초기 발병 정신분열증 스펙트럼 장애의 일차 DSM-IV 진단; 양극성 I 장애 조증(및 BP-NOS); Leibenluft et al. (2011) ABC-과민성 점수 >/=18 성적으로 활동적인 소녀는 두 가지 효과적인 피임 방법을 사용하거나 금욕하는 데 동의해야 합니다.
- 참가자에게는 연구 시작 전 최소 6개월 동안 아동을 잘 알고 있는 일차 보호자가 있습니다. 일차 보호자는 연구 약속에 참여할 수 있습니다.
- 조사자의 임상적 판단에 따라 프로토콜의 모든 측면에 참여하는 아동의 능력.
제외 기준:
- 체중에 영향을 미치는 주요 신경학적 또는 의학적 질병(예: 불안정한 갑상선 질환)에는 금지된 전신 약물(예: 진성 당뇨병[인슐린], 만성 신부전[스테로이드)이 필요합니다. 스크리닝 중 2회에 공복 혈당 > 125 mg/dL
- 체중을 현저하게 변화시키는 모든 약물(현재 처방된 향정신성 약물 제외)
- BP-I 또는 BP-NOS 환자에서 항우울제는 최소 2주 동안 허용되지 않습니다.
- 거식증 또는 신경성 폭식증의 DSM-IV 진단
- 지난 1개월 이내에 물질 의존 장애(담배 의존 제외)의 DSM-IV 진단
- 초기 소변 독성 검사 및 후속 검사는 불법 물질의 지속적인 사용을 나타냅니다.
- ZIP 또는 UC 항정신병약에 대한 과민증
- 임신, 모유 수유 또는 피임 요구 사항을 따르지 않으려는 경우
- 스크리닝 또는 베이스라인 QTc > 450msec
- IQ < 55
- 자신이나 타인에게 위험할 수 있는 중대한 위험
- 새로운 부서의 사회 서비스 개입이 필요한 진행 중이거나 이전에 공개되지 않은 아동 학대.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 지프라시돈
(20-160mg/d, bid) 12주 동안
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ZIP에 무작위 할당(20-160mg/d, 입찰 용량)
다른 이름들:
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활성 비교기: 아리피프라졸, 퀘티아핀, 리스페리돈
12주간 아리피프라졸(2-30mg/d), 퀘티아핀(25-800mg/d) 또는 리스페리돈(0.1-8mg/d)
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Usual Care 항정신병약 UC 항정신병약(아리피프라졸 2-30mg/d, 퀘티아핀 25-800mg/d 또는 리스페리돈 0.1-8mg/d)
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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체중 변화
기간: 기준선에서 12주까지
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기준선에서 12주까지
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2차 결과 측정
결과 측정 |
기간 |
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기준선 체중과 비교한 체중 변화율
기간: 기준선에서 12주까지
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기준선에서 12주까지
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BMI Z-점수
기간: 기준선에서 12주까지
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기준선에서 12주까지
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BMI 백분위수
기간: 기준선에서 12주까지
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기준선에서 12주까지
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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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
2013년 7월 1일
기본 완료 (실제)
2014년 4월 1일
연구 완료 (실제)
2014년 4월 1일
연구 등록 날짜
최초 제출
2013년 4월 29일
QC 기준을 충족하는 최초 제출
2013년 4월 30일
처음 게시됨 (추정)
2013년 5월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 2월 5일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 1월 6일
마지막으로 확인됨
2016년 1월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 12-403A
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지프라시돈에 대한 임상 시험
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Northwestern UniversityNational Alliance for Research on Schizophrenia and Depression종료됨
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Icahn School of Medicine at Mount SinaiNational Institute of Mental Health (NIMH)완전한정신 분열증