소아 환자의 양극성 우울증 치료를 위한 Lumateperone의 다기관 연구
10~17세 소아 환자의 양극성 I 또는 양극성 II 장애(양극성 우울증)와 관련된 주요 우울증 에피소드(MDE) 치료를 위한 루마테페론의 효능 및 안전성을 평가하기 위한 무작위, 이중 맹검, 위약 대조, 다기관 연구 연령
This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL), according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).
연구 개요
상세 설명
The study will be conducted in 3 phases:
- Screening Period (up to 2 weeks) during which patient eligibility will be assessed
- Double-blind Treatment Period (6 weeks) during which all patients will be randomized to receive lumateperone or placebo in 1:1 ratio.
- Safety Follow-up Period (1 week) during which all patients will return to the clinic for a safety follow-up (SFU) visit approximately one 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
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Alabama
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Dothan, Alabama, 미국, 36303
- 모병
- Harmonex Neuroscience Research
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Arkansas
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Little Rock, Arkansas, 미국, 72204
- 모병
- Pillar Clinical Research, LLC
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California
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Anaheim, California, 미국, 92805
- 모병
- Advanced Research Center, Inc
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Redlands, California, 미국, 92373
- 모병
- Inland Psychiatric Medical Group Inc
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Sacramento, California, 미국, 95817
- 모병
- UC Davis Health System
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San Diego, California, 미국, 92103
- 완전한
- University of California San Diego Medical Center
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West Covina, California, 미국, 91790
- 모병
- Next Level Clinical Trials, LLC
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Colorado
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Colorado Springs, Colorado, 미국, 80910
- 완전한
- MCB Clinical Research Centers LLC
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Florida
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Fort Myers, Florida, 미국, 33901
- 정지된
- Royal Palm Clinical Research
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Hialeah, Florida, 미국, 33012
- 완전한
- United Research Institute
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Homestead, Florida, 미국, 33033
- 정지된
- Advanced Research Institute of Miami
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Miami, Florida, 미국, 33176
- 모병
- Links Clinical Trials
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Miami, Florida, 미국, 33125
- 완전한
- Columbus Clinical Services LLC
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Miami, Florida, 미국, 33122
- 정지된
- Vital Care Research
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Miami, Florida, 미국, 33130
- 모병
- Care Research Center Inc
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Miami, Florida, 미국, 33165
- 정지된
- AP Medical Research
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Miami, Florida, 미국, 33134
- 모병
- HealthMed Clinical Center Inc
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Miami, Florida, 미국, 33144
- 완전한
- Ocean Blue Medical Research Center Inc.
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Miami, Florida, 미국, 33166
- 모병
- Envision Trials LLC
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Miami, Florida, 미국, 33186
- 완전한
- SouthGen Clinical Research LLC
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Miami, Florida, 미국, 33173
- 완전한
- GTL Medical and Research Group
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Miami Gardens, Florida, 미국, 33056
- 모병
- New Med Research Inc
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Miami Gardens, Florida, 미국, 33169
- 모병
- The Angel Medical Research Corporation
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Miami Lakes, Florida, 미국, 33014
- 모병
- Riveldi Biomedical Research
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Orlando, Florida, 미국, 32803
- 모병
- APG Research LLC
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West Palm Beach, Florida, 미국, 33407
- 모병
- Health Synergy Clinical Research
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Georgia
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Atlanta, Georgia, 미국, 30030
- 모병
- CenExeli Research LLC
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Atlanta, Georgia, 미국, 30318
- 완전한
- Advanced Discovery Research
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Lawrenceville, Georgia, 미국, 30046
- 완전한
- Salveo Integrative Health Inc
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Savannah, Georgia, 미국, 31405
- 모병
- CenExeli Research LLC 1
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Illinois
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Chicago, Illinois, 미국, 60611
- 모병
- Ann & Robert H. Lurie Children's Hospital of Chicago
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Elgin, Illinois, 미국, 60123
- 모병
- Revive Research Institute
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Indiana
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Indianapolis, Indiana, 미국, 46202
- 완전한
- Indiana University
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Maryland
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Baltimore, Maryland, 미국, 21229
- 완전한
- MTP Psychiatry LLC
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Michigan
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Bloomfield Hills, Michigan, 미국, 48302
- 모병
- Neurobehavioral Medicine Group
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Missouri
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Saint Charles, Missouri, 미국, 63304
- 모병
- Midwest Research Group
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St Louis, Missouri, 미국, 63110
- 완전한
- Washington University School of Medicine Child and Adolescent Psychiatry Clinic
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Nebraska
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Lincoln, Nebraska, 미국, 68526
- 모병
- Alivation Research LLC
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New York
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New York, New York, 미국, 10016
- 모병
- NYU Child Study Center
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Ohio
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Avon Lake, Ohio, 미국, 44012
- 완전한
- Haidar Almhana Nieding
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Cincinnati, Ohio, 미국, 45219
- 모병
- University of Cincinnati Medical Center
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Garfield Heights, Ohio, 미국, 44125
- 모병
- Charak Center for Health and Wellness
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Westlake, Ohio, 미국, 44145
- 완전한
- Westlake America Clinic
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73116
- 완전한
- Cutting Edge Research Group
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Oklahoma City, Oklahoma, 미국, 73116
- 모병
- Sooner Clinical Research
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Oklahoma City, Oklahoma, 미국, 73112
- 모병
- SP Research, PLLC (dba Rivus Wellness & Research Institute)
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Texas
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Austin, Texas, 미국, 78701
- 모병
- The University of Texas at Austin
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Austin, Texas, 미국, 78759
- 완전한
- BioBehavioral Research of Austin PC
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Beaumont, Texas, 미국, 77701
- 모병
- REX Clinical Trials LLC
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Flower Mound, Texas, 미국, 76028
- 완전한
- North Pointe Psychiatry
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Houston, Texas, 미국, 77090
- 완전한
- Red Oak Psychiatry Associates
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Houston, Texas, 미국, 77089
- 모병
- Kaleidoscope Clinical Research
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Richmond, Texas, 미국, 77407
- 모병
- Perceptive Pharma Research
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Virginia
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Richmond, Virginia, 미국, 23220
- 모병
- Virginia Commonwealth University
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Washington
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Bellevue, Washington, 미국, 98007
- 모병
- Northwest Clinical Research Center
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Everett, Washington, 미국, 98201
- 모병
- Core Clinical Research
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Belgrade, 세르비아, 11000
- 모집하지 않고 적극적으로
- Clinic of Neurology and Psychiatry for Children and Youth
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Belgrade, 세르비아, 11000
- 모집하지 않고 적극적으로
- Institute of Mental Health Serbia
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Niš, 세르비아, 18000
- 모집하지 않고 적극적으로
- University Clinical Center NIS
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Novi Sad, 세르비아, 21000
- 정지된
- Clinical Center of Vojvodina
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Ahmedabad, 인도, 380008
- 정지된
- Ratandeep Surgical Hospital And Endoscopy Clinic
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Chhatrapati Sambhajinagar, 인도, 431005
- 정지된
- Society for Psychiatric Update and Research Shanti Nursing Home
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Nashik, 인도, 422005
- 정지된
- Chopda Medicare & Research Centre
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Varanasi, 인도, 221005
- 정지된
- Deva Institute of Healthcare And Research Pvt Ltd
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Barranquilla, 콜롬비아, 080020
- 모병
- Centro de Investigaciones y Proyectos en Neurociencias CIPNA
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Bello, 콜롬비아, 051053
- 모병
- Empresa Social del Estado Hospital Mental de Antioquia Maria Upegui HOMO
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Bogotá, 콜롬비아, 111166
- 완전한
- Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda.
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Pereira, 콜롬비아, 660002
- 모병
- Psynapsis Salud Mental S.A.
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
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Able to provide consent as follows:
- The Legally Authorized Representative (LAR) must provide written, informed consent.
- The patient must provide written assent;
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Male or female patients 10 to 17 years of age, inclusive;
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Have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of bipolar I or bipolar II disorder with a current MDE without psychosis as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL);
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Subject has a lifetime history of at least one manic or hypomanic episode.
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Subject's current major depressive episode is ≥ 4 weeks and less than 12 months in duration;
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CDRS-R total score ≥ 45 with ≥ 5 on Item 11 (depressed feelings) at Screening and Baseline;
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Young Mania Rating Scale (YMRS) score ≤ 15 (with YMRS Item 1 [elevated mood] score ≤ 2) at Screening and Baseline.
Exclusion Criteria:
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Has a primary psychiatric diagnosis other than bipolar I or bipolar II disorder. Exception includes:
- Attention deficit hyperactivity disorder (ADHD). If a subject is taking medications for ADHD, they must have been 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.
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Intellectual disability based on Investigator opinion and DSM-5 criteria
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Patient has been hospitalized for a bipolar manic episode within the 30 days prior to randomization;
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Demonstrates a ≥ 25% decrease (improvement) in the CDRS-R total score between Screening and Baseline visits, or the CDRS-R is below 45 at Baseline;
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In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her 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
- At Screening or Baseline, scores > 3 on Item 13 (suicidal ideation) on the CDRS-R; or
- The patient is considered to be an imminent danger to him/herself 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 |
|---|---|
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실험적: Lumateperone
Lumateperone 42 mg for patient ages 13-17 years and Lumateperone 21 mg for patient ages 10-12 years. |
Lumateperone administered orally, once daily. |
|
위약 비교기: Placebo
Matching placebo |
Matching placebo administered orally, once daily. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Children's Depression Rating Scale-Revised (CDRS-R)
기간: Week 6
|
The Children's Depression Rating Scale-Revised is an observer-rated, 17-item semi-structured scale for pediatric patients. The scale comprises cognitive, somatic, affective, and psychomotor symptoms of depression. Items are rated for severity on a 7-point scale (1 to 7) for 14 items and on a 5-point scale (1 to 5) for three items. Total scores range from 7 to 113. |
Week 6
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Clinical Global Impression Scale-Severity (CGI-S)
기간: Week 6
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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-007-421
- ITI-007-421 (기타 식별자: Janssen Research & Development, LLC)
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. .