- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Ontario
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Toronto, Ontario, Canada, M4G 1R8
- Holland Bloorview Kids Rehabilitation Hospital
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55455
- University of Minnesota
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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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Autres noms:
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Comparateur placebo: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Cognition
Délai: 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
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12 Weeks
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Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Cognition
Délai: 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
Délai: 12 Weeks
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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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Evdokia Anagnostou, M.D., Holland Bloorview Kids Rehabilitation Hospital
- Chercheur principal: Suma Jacob, M.D., Ph.D., University of Minnesota
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- OXY-R07-2013
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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