- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01908205
Intranasal Oxytocin for the Treatment of Children and Adolescents With Autism Spectrum Disorders (ASD) (OXY-R)
Intranasal Oxytocin for the Treatment of Children and Adolescents With Autism
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria
- Male or female outpatients, 10-17 years of age inclusive.
- Meet Diagnostic and Statistical Manual of Mental Disorders, 4th Edition. Diagnostic and Statistical Manual (DSM-IV) criteria will be established by a clinician with expertise with individuals with ASD. Best estimate Diagnosis will be reached using DSM-IV criteria, the Autism Diagnostic Observation Schedule (ADOS-2) and the Autism Diagnostic Interview (ADI-R).
- Have a Clinician's Global Impression-Severity (CGI-S) score ≥ 4 (moderately ill) at Screening.
- Verbal and performance scale Intelligence Quotient (IQ) ≥ 70 (both subtests of the Wechsler Abbreviated Scale of Intelligence (WASI-I or WASI-II ≥ 70).
- If already receiving stable concomitant medications affecting behavior, have continuous participation for 1 month prior to Screening (with the exception of fluoxetine, where a period of 6 weeks is needed), and not electively initiate new or modify ongoing medications for the duration of the study.
- If already receiving stable non-pharmacologic educational, behavioral, and/or dietary interventions, have continuous participation during the preceding 3 months prior to Screening, and not electively initiate new or modify ongoing interventions for the duration of the study.
- Have normal physical examination and laboratory test results at Screening. If abnormal, the finding(s) must be deemed not clinically significant by the Treating Clinician.
- Ability to speak and understand English sufficiently to allow for the completion of all study assessments.
- Ability to obtain written informed consent from the participant, if developmentally appropriate. If a participant does not have the capacity to consent, ability to obtain assent (if developmentally appropriate), as well as written informed consent from their parent(s)/legal guardian.
Exclusion Criteria
- Patients born prior to 35 weeks gestational age.
- Patients with a primary psychiatric diagnosis other than ASD.
- Patients with a medical history of neurological disease, including, but not limited to, epilepsy/seizure disorder (except simple febrile seizures), movement disorder, tuberous sclerosis, fragile X, and any other known genetic syndromes, or known abnormal brain MRI/structural lesion.
- Pregnant female patients, sexually active female patients on hormonal birth control and sexually active females who do not use at least two types of non-hormonal birth control.
- Patients with evidence or history of malignancy or any significant hematological, endocrine, cardiovascular (including any rhythm disorder), respiratory, renal, hepatic, or gastrointestinal disease.
- Patients with one or more of the following: HIV, Hepatitis B virus, Hepatitis C virus, hemophilia (bleeding problems, recent nose and brain injuries), abnormal blood pressure (hypotension or hypertension), drug abuse, immunity disorder or severe depression.
- Patients who are currently taking oxytocin or have taken intranasal oxytocin in the past with no response.
- Patients with a sensitivity to oxytocin or any components of its formulation.
- Patients unable to tolerate venipuncture procedures for blood sampling.
- Patients in foster care for whom the province/state is defined as a legal guardian
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 |
---|---|
실험적: Intranasal Oxytocin (Syntocinon)
The proposed dosing schedule is 0.4 IU/kg, taken twice daily, for a maximum of 24 IUs per dose
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다른 이름들:
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위약 비교기: Placebo
The proposed dosing schedule is 0.4 IU/kg, taken twice daily, for a maximum of 24 IUs per dose
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function
기간: 12 and 24 weeks
|
This will be measured by a change in score on the Aberrant Behavior Checklist (ABC) - Social Withdrawal Subscale (0-48, where lower scores indicate improvement)
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12 and 24 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Cognition
기간: 12 Weeks
|
This will be measured by a change in score the Revised Eyes Test (0- 28; where higher scores indicate better performance/improvement) Baseline to Week 12
|
12 Weeks
|
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Cognition
기간: 12 Weeks
|
This will be measured by improvement on the Let's Face it! Skills Battery from Baseline to Week 12 Social Cognition (higher score=better outcome) a. Let's Face It Skills Battery; i. Matchmaker (0-100); ii. Faces (0-100); iii. Houses (0-100) |
12 Weeks
|
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function
기간: 12 Weeks
|
This will be measured by improvement on the Behavioral Assessment System for Children (BASC-2) from Baseline to Week 12 Behavioral Assessment System for Children (higher score=positive response); i. *Social Skills: age 6 to 11 (18-69); age 12 to 17 (21-70); ii. Functional Communication: age 6 to 11 (10-66); age 12 to 17 (10-64); iii. Withdrawal age 6-11 (21- 62) ; age 12-17 (14-42) * only social subscales of BASC-2 reported |
12 Weeks
|
Number of Participant Considered Social Responders
기간: 12 Weeks
|
This will be measured by the Clinical Global Impressions - Improvement Scale - Social (CGI-I-Social) a) Clinical Global Impressions - Social Scale (1-7) (lower score=positive response). The results will be reported as the number of participants that were classified as a social responder (achieving a score of 1 or 2 on the scale). |
12 Weeks
|
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Repetitive Behaviors
기간: 12 Weeks
|
This will be measured by improvement on the Child Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) from Baseline to Week 12 -lower score= positive response (0-20) |
12 Weeks
|
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Repetitive Behaviors
기간: 12 Weeks
|
This will be measured by improvement on the Repetitive Behavior Scale (RBS-R)(0-129; where lower score= positive response) from Baseline to Week 12
|
12 Weeks
|
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Anxiety
기간: 12 Weeks
|
This will be measured by the Child and Adolescent Symptom Inventory (CASI-4R) Generalized anxiety score (male (40-101); female (41-96) -where lower score= positive response) from Baseline to Week 12
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12 Weeks
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Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Quality of Life
기간: 12 Weeks
|
This will be measured by improvement on the Pediatric Quality of Life Inventory (PedsQL) (0-100, where higher scores indicate positive response) from Baseline to Week 12
|
12 Weeks
|
Number of Participant Considered Overall Responders
기간: 12 Weeks
|
This will be measured by the Clinical Global Impressions - Improvement Scale - Global (CGI-I-Global) (1-7) (lower score=positive response).
The results will be reported as the number of participants that were classified as an overall responder (achieving a score of 1 or 2 on the scale).
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12 Weeks
|
Safety and Tolerability of Intranasal Oxytocin in Children and Adolescents With ASD
기간: 12 Weeks
|
This will be measured by the Safety Monitoring Uniform Report Form (SMURF)
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12 Weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Evdokia Anagnostou, M.D., Holland Bloorview Kids Rehabilitation Hospital
- 수석 연구원: Suma Jacob, M.D., Ph.D., University of Minnesota
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
자폐 스펙트럼 장애에 대한 임상 시험
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University Hospital, Basel, SwitzerlandGebert Rüf-Stiftung모집하지 않고 적극적으로ESBL(Extended Spectrum Beta Lactamases) 대장균스위스
위약에 대한 임상 시험
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AJU Pharm Co., Ltd.OM Pharma SA모병
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University Hospital, Strasbourg, France모집하지 않고 적극적으로