E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Autism Spectrum Disorder (Autism, Asperger's Syndrome) Conduct Disorder Mild Mental Retardation |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003805 |
E.1.2 | Term | Autism |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10064478 |
E.1.2 | Term | Conduct disorder |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027618 |
E.1.2 | Term | Mild mental retardation |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
It will be investigated whether the administration of oxytocin improves empathic functioning, and if so, which aspects will be improved. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
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E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The study will terminate prematurely if electrophysiological measurements or the oxytocin trial in any way does harm to the population of interest. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |