Neural and Behavioral Effects of Oxytocin in Autism Spectrum Disorders
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 4

Summary: 
      The current trial aims to explore the neural and behavioral effects of oxytocin in autism
      spectrum disorders (ASD). Oxytocin is a nonapeptide produced by the paraventricular and
      supraoptic nuclei of the hypothalamus and is known to play a pivotal role in a variety of
      complex social behaviors. Initial studies showed that intranasal administration of oxytocin
      can have a positive effect on social functioning in ASD.

      However, future studies are necessary to explore whether and how oxytocin effects neural
      processes in the brain underlying these behavioral improvements. This trial will not only
      measure behavioral enhancements, but will specifically focus on elucidating the associated
      neurophysiological changes by guiding the administration of oxytocin with regular
      neurophysiological assessments.
    

Detailed description: 
      The present study is a monocentric, between-subjects, randomized, placebo-controlled trial.
      The investigators will recruit approximately 40 young-adult, male individuals with a clinical
      diagnosis of Autism Spectrum Disorder (ASD). Participants will be randomly allocated to an
      experimental group (Oxytocin (OT)) and a control group (Placebo (PL)). All participants will
      receive the same frequency and duration of intervention. Behavioral and neural outcome
      measures will be assessed at multiple time points in a period of a year. Participants will be
      tested at 5 occasions: before and after a single dose of nasal spray, after multiple doses of
      nasal spray (1 daily dose of nasal spray during 4 weeks), after a 4-week retention period and
      after a 1-year retention period. At each time point participants will be tested at both the
      behavioral and neural level. Test performance of both participant groups (OT vs PL) will be
      compared by measuring reaction times and accuracy rates in a computerized task assessing a
      person's ability to recognize bodily emotional states from point light displays. In addition,
      attachment, social functioning, restricted behaviour, general quality of life and mood will
      be assessed via self-reported questionnaires.

      Functional MRI measurements will be performed in a 3T MR Philips Intera scanner. Before
      scanning, subjects will undergo a training session to familiarize them with the task
      instructions. In addition to the fMRI measurements, resting state fMRI and Diffusion Tensor
      Imaging (DTI) will also be performed to reveal alterations of the functional and structural
      connectivity between critical regions.

      Statistical analysis of the behavioral data will have a between-subject factor of group (OT
      vs PL) and within-subject factors of time (change-from-baseline). Image analysis will be
      performed with Statistical Parametric Mapping (SPM) software. The investigators will contrast
      for either decreased or increased activation, as different regions may show divergent changes
      due to the received nasal spray (either OT or PL).
    

Intervention name(s): Syntocinon (Oxytocin); Placebo (Physiological water (solution of sodium chloride (NaCl) in water))
Intervention type(s): Drug; Other
Intervention description(s): Syntocinon nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray; Placebo nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Oxytocin; Autism Spectrum Disorders