E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
subjects with autism spectrum disorder and neurotypical controls |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10063844 |
E.1.2 | Term | Autism spectrum disorder |
|
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 |
The overall aim of the proposed project is to investigate attentional processes in a social context and to modulate these processes by OXT. Based on the literature to date, it seems plausible that OXT modulates social cognitive processes such as the attention to emotional facial expressions differentially in ASD and neurotypical controls. Thus, the present study aims to investigate the modulatory role of OXT on attentional capture of social stimuli with varying emotional valence on the behavioral level in both typically developing adults as well as individuals with ASD. Participants will receive either OXT or a placebo in a randomized, double-blind group design. |
|
E.2.2 | Secondary objectives of the trial |
- Investigate whether OXT improves the attentional focus to social/emotional stimuli in the ASD group, but attenuates the attentional focus for aversive/negative social stimuli in neurotypical individuals as compared to positive social cues - Examine the neural basis of the expected behavioral effects using fMRI |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- age: 18 - 50 years - ASD-group only: diagnosed autism spectrum disorder (DSM-IV: 299.00, 299.80) - male - right-handed - non-smoker - German native-speaker - normal or corrected-to-normal vision - written informed-consent
|
|
E.4 | Principal exclusion criteria |
- somatic illness - endocrinological or psychoactive medication - controls only: current or past diagnosis of neurological or psychiatric disorder - ASD-group only: dominant psychiatric comorbidity (DSM-IV axis I / II) - on the day of behavioral testing: caffeinated beverages and alcohol; drinking or eating anything except water for two hours before testing - hypersensitivity towards the active substance or other ingredients (e.g. preservatives like parabens) - fMRI-group only: non-MRI-compatible conditions (e.g. metal in body) - mental retardation (IQ < 70) - speech development disorder
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
- reaction time and saccadic patterns in a facial dot-probe paradigm (using high-speed remote eyetracking) - limbic activity in response to facial stimuli |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
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 | Yes |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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
|
see protocol: "Zeitplan der Studie", "Studienabbruch" |
|
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 |