소아 환자의 자폐 스펙트럼 장애와 관련된 과민성 치료를 위한 Lumateperone의 다기관 연구
5~17세 소아 환자의 자폐 스펙트럼 장애와 관련된 과민성 치료에서 루마테페론의 효능과 안전성을 평가하기 위한 무작위, 이중 맹검, 위약 대조, 다기관 연구
This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients aged 5 to 17 years with a primary diagnosis of irritability associated with Autism Spectrum Disorder (ASD) based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) and confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia Present and Lifetime Version (K-SADS-PL).
연구 개요
상태
상세 설명
The study will be conducted in 3 phases:
- Screening Period (up to 14 days) during which patient eligibility will be assessed.
- Double-blind Treatment Period (DBTP) (6 weeks) during which all patients will be randomized in a 1:1:1 ratio to receive either lumateperone high dose, lumateperone low dose, or placebo as a once daily dose.
- Safety Follow-up Period (1 week) during which all patients will return to the clinic for a safety follow-up (SFU) visit approximately 1 week after the last dose of study drug.
연구 유형
등록 (추정된)
단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Study Contact
- 전화번호: 844-434-4210
- 이메일: Participate-In-This-Study1@its.jnj.com
연구 장소
-
-
Alabama
-
Dothan, Alabama, 미국, 36303
- 모병
- Harmonex Neuroscience Research
-
-
Arizona
-
Phoenix, Arizona, 미국, 85006
- 모병
- Southwest Autism Research and Resource Center
-
-
California
-
Anaheim, California, 미국, 92805
- 모병
- Advanced Research Center Inc
-
Oceanside, California, 미국, 92056
- 모병
- Excell Research Inc
-
Redlands, California, 미국, 92373
- 모병
- Inland Psychiatric Medical Group Inc
-
Upland, California, 미국, 91786
- 완전한
- Buena Park Research
-
West Covina, California, 미국, 91790
- 모병
- Next Level Clinical Trials, LLC
-
-
Colorado
-
Colorado Springs, Colorado, 미국, 80910
- 완전한
- MCB Clinical Research Centers LLC
-
-
Florida
-
Fort Myers, Florida, 미국, 33901
- 정지된
- Royal Palm Clinical Research
-
Gainesville, Florida, 미국, 32607
- 모병
- Sarkis Clinical Trials
-
Jacksonville, Florida, 미국, 32258
- 모병
- Green Leaf Clinical Trials
-
Miami, Florida, 미국, 33176
- 모병
- Anchor Medical Research LLC
-
Miami, Florida, 미국, 33176
- 모병
- Links Clinical Trials
-
Miami, Florida, 미국, 33125
- 모병
- Columbus Clinical Services LLC
-
Miami, Florida, 미국, 33175
- 모병
- Diverse Clinical Research LLC
-
Miami, Florida, 미국, 33166
- 모병
- South Florida Research Phase I-IV
-
Miami Gardens, Florida, 미국, 33169
- 모병
- The Angel Medical Research Corporation
-
West Palm Beach, Florida, 미국, 33407
- 모병
- Health Synergy Clinical Research
-
-
Georgia
-
Savannah, Georgia, 미국, 31405
- 모병
- CenExeli Research LLC
-
-
Illinois
-
Elgin, Illinois, 미국, 60123
- 모병
- Revive Research Institute
-
Springfield, Illinois, 미국, 62701
- 정지된
- Southern Illinois University School of Medicine
-
-
Massachusetts
-
Boston, Massachusetts, 미국, 02114
- 완전한
- Massachusetts General Hospital
-
Worcester, Massachusetts, 미국, 01655
- 모병
- UMass Memorial Healthcare
-
-
Missouri
-
Saint Charles, Missouri, 미국, 63304
- 모병
- Midwest Research Group
-
-
Nevada
-
Las Vegas, Nevada, 미국, 89128
- 모병
- Vector Clinical Trials
-
-
Ohio
-
Garfield, Ohio, 미국, 44125
- 모병
- Charak Center for Health and Wellness
-
Westlake, Ohio, 미국, 44145
- 완전한
- Westlake Brain Health
-
-
Tennessee
-
Nashville, Tennessee, 미국, 37203
- 모병
- Access Clinical Trials
-
-
Texas
-
Beaumont, Texas, 미국, 77701
- 모병
- REX Clinical Trials LLC
-
Flower Mound, Texas, 미국, 76028
- 완전한
- North Pointe Psychiatry
-
Houston, Texas, 미국, 77089
- 모병
- Kaleidoscope Clinical Research
-
Plano, Texas, 미국, 75093
- 모병
- AIM Trials
-
Richmond, Texas, 미국, 77407
- 모병
- Perceptive Pharma Research
-
-
Virginia
-
Petersburg, Virginia, 미국, 23805
- 모병
- Clinical Research Partners, LLC
-
-
Washington
-
Bellevue, Washington, 미국, 98007
- 모병
- Northwest Clinical Research Center
-
-
-
-
-
Belgrade, 세르비아, 11000
- 모병
- Institute of Mental Health Serbia
-
Belgrade, 세르비아, 11000
- 모병
- Institute of Mental Health Serbia 1
-
Belgrade, 세르비아, 11070
- 모병
- Clinic of Neurology and Psychiatry for Children and Youth
-
Niš, 세르비아, 18000
- 모병
- University Clinical Center NIS
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
-
All patients must have a legally authorized representative LAR (eg, parent or legal guardian) who is willing and able to be responsible for the safety and well-being of the patient, provide information about the patient's condition, and accompany the patient to study visits.
-
Able to provide consent as follows:
- The patient's LAR must provide written, informed consent.
- When developmentally appropriate based on Investigator judgment, the patient should provide written assent.
-
Male or female patients 5 to 17 years of age. Currently, only patients aged 13 to 17 years will be eligible for enrollment.
-
Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of ASD as confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL);
-
ABC-I subscale score of >18 at Screening and Baseline;
-
CGI-S score > 4 with respect to irritability associated with ASD at Screening and Baseline.
Exclusion Criteria:
-
Has a primary psychiatric diagnosis other than ASD. Exceptions include:
- Attention Deficit Hyperactivity Disorder (ADHD). If a patient is taking medication(s) for ADHD, they must be on a stable treatment regimen of these medication(s) for 30 days prior to screening and the treatment regimen is expected to remain stable throughout the study. This must be confirmed by the Investigator and noted in the source records.
- Mild and moderate intellectual disability based on Investigator judgment and DSM-5 criteria (severe and profound intellectual disability are excluded).
-
History or current diagnosis of Rett syndrome or Fragile X syndrome;
-
In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or
- At Screening, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening or, at Baseline, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit;
- At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or
- The patient is considered to be an imminent danger to themselves or others.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
위약 비교기: Placebo
Placebo |
Matching Placebo administered orally once daily |
|
실험적: Lumateperone high dose
Lumateperone 42 mg for patients ages 13-17 years old |
Lumateperone administered orally once daily |
|
실험적: Lumateperone low dose
Lumateperone 21 mg for patients ages 13-17 years old |
Lumateperone administered orally once daily |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Aberrant Behavior Checklist - Irritability (ABC-I)
기간: Week 6
|
The ABC-I subscale contains 15 items which rate symptoms on a scale ranging from 0 (not at all a problem) to 3 (severe). |
Week 6
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Clinical Global Impression-Severity (CGI-S)
기간: Week 6
|
The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). |
Week 6
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Intra-Cellular Therapies, Inc. Clinical Trial, Intra-Cellular Therapies, Inc.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ITI-007-601
- ITI-007-601 (기타 식별자: Janssen Research & Development, LLC)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .