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
調査の概要
詳細な説明
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的: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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他の名前:
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プラセボコンパレーター:Placebo
The proposed dosing schedule is 0.4 IU/kg, taken twice daily, for a maximum of 24 IUs per dose
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function
時間枠:12 and 24 weeks
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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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Cognition
時間枠:12 Weeks
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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
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12 Weeks
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Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Cognition
時間枠:12 Weeks
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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
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Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function
時間枠: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
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Number of Participant Considered Social Responders
時間枠:12 Weeks
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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
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Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Repetitive Behaviors
時間枠:12 Weeks
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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
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Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Repetitive Behaviors
時間枠:12 Weeks
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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
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12 Weeks
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Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Anxiety
時間枠:12 Weeks
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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
時間枠:12 Weeks
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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
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12 Weeks
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Number of Participant Considered Overall Responders
時間枠:12 Weeks
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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
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Safety and Tolerability of Intranasal Oxytocin in Children and Adolescents With ASD
時間枠:12 Weeks
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This will be measured by the Safety Monitoring Uniform Report Form (SMURF)
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12 Weeks
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Evdokia Anagnostou, M.D.、Holland Bloorview Kids Rehabilitation Hospital
- 主任研究者:Suma Jacob, M.D., Ph.D.、University of Minnesota
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
自閉症スペクトラム障害の臨床試験
プラセボの臨床試験
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Palacky University完了
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Universidade Federal do ParaConselho Nacional de Desenvolvimento Científico e Tecnológico完了
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University Hospital, Strasbourg, France積極的、募集していない