Autism Spectrum Disorder (Autism, Asperger's Syndrome) Conduct Disorder Mild Mental Retardation MedDRA version: 9.1 Level: LLT Classification code 10003805 Term: Autism MedDRA version: 9.1 Level: LLT Classification code 10064478 Term: Conduct disorder MedDRA version: 9.1 Level: LLT Classification code 10027618 Term: Mild mental retardation
Conditions
Interventions
Trade Name: Syntocinon
Product Name: oxytocin
Product Code: RVG 03716
Pharmaceutical Form: Nasal spray*
Pharmaceutical form of the placebo: Nasal spray*
Route of administration of the placebo: Intrana
Sponsors
KARAKTER universitair centrum voor kinder- en jeudpsychiatrie
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Boys, aged 12 to 19 years, with an average intelligence (Total IQ = 85; according to DSM-IV-TR), and with a diagnosis of Autism of Conduct Disorder. Subjects need to meet criteria according to the DISC-IV computer version. This is a structured questionnaire, which has to be filled in by parents, and which aims at psychopathology according to DSM-IV-TR criteria Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Youth using medication which can influence facial expression (i.e., antipsychotics and certain antidepressants) and temporary discontinuation of medication is contraindicated (i.e., psychotic disorder, severe major depression) will be excluded. Whether discontinuation is appropriate will be decided by mutual agreement with the subject, the psychiatrist treating the subject, and if necessary, parents of the subject. If so, discontinuation will last for at least 5 times half-life of the medication used, and will be continued the day after participation in the investigation. Furthermore, youth with prominent comorbidity which could influence neurologic or neurocognitive functioning, such as: • schizofrenia, psychotic disorder • bipolar disorder • substance abuse of dependency • tics • language disorder • epilepsy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: It will be investigated whether the administration of oxytocin improves empathic functioning, and if so, which aspects will be improved.;Secondary Objective: The objective is to investigate differences and/or similarities in the lack of empathy with several psychiatric disorders, in which this deficiency is a known core symptom. ;Primary end point(s): Neurocognitive functioning on Theory of Mind and empathic functioning as measured by psychological tests. In response to pictures of emotional faces: • Facial musculature • Heart beat • Skin conductance | — |
Countries
Netherlands
Outcome results
None listed