Clinical Trial: Neural and Behavioral Effects of Oxytocin in Autism Spectrum Disorders

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Oxytocin-based Pharmacotherapy for Autism Spectrum Disorders: Investigating the Neural and Behavioral Effects of a Promising Intervention Approach

Brief 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 Summary:

The present study is a monocentric, between-subjects, randomized, placebo-controlled trial. The investigators will recruit approximately 42 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 (T1) and after (T2) a single dose of nasal spray, after multiple doses of nasal spray (1 daily dose of nasal spray during 4 weeks) (T3), after a 4-week retention period (T4) and after a 48-week retention period (T5). 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 at time point T2, T3, T4 and T
Sponsor: Katholieke Universiteit Leuven

Current Primary Outcome:

  • Change from baseline in performance on the emotion recognition task (accuracy, reaction time) after a single dose of nasal spray [ Time Frame: 30 minutes ]
  • Change from baseline in performance on the emotion recognition task (accuracy, reaction time) after 4 weeks of nasal spray [ Time Frame: 4 weeks ]
  • Change from baseline in performance on the emotion recognition task (accuracy, reaction time) after 8 weeks (including 4 weeks without nasal spray) [ Time Frame: 8 weeks ]
  • Change from baseline in performance on the emotion recognition task (accuracy, reaction time) after 52 weeks (including 48 weeks without nasal spray) [ Time Frame: 52 weeks ]
  • Change from baseline in brain activity during task (task-based fMRI) after a single dose of nasal spray [ Time Frame: 30 minutes ]
  • Change from baseline in brain activity during task (task-based fMRI) after 4 weeks of nasal spray [ Time Frame: 4 weeks ]
  • Change from baseline in brain activity during task (task-based fMRI) after 8 weeks, including 4 weeks without nasal spray [ Time Frame: 8 weeks ]
  • Change from baseline in brain activity during task (task-based fMRI) after 52 weeks, including 48 weeks without nasal spray [ Time Frame: 52 weeks ]
  • Change from baseline in brain activity during rest (resting-state fMRI) after a single dose of nasal spray [ Time Frame: 30 minutes ]
  • Change from baseline in brain activity during rest (resting-state fMRI) after 4 weeks of nasal spray [ 

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Change from baseline in informant-based-report scores on one questionnaire assessing mood after a single dose of nasal spray [ Time Frame: 30 minutes ]
    • Change from baseline in informant-based-report scores on questionnaires assessing attachment, social functioning, quality of life and mood after 4 weeks of nasal spray [ Time Frame: 4 weeks ]
    • Change from baseline in informant-based-report scores on questionnaires assessing attachment, social functioning, quality of life and mood after 8 weeks, including 4 weeks without nasal spray [ Time Frame: 8 weeks ]
    • Change from baseline in informant-based-report scores on questionnaires assessing attachment, social functioning, quality of life and mood after 52 weeks, including 48 weeks without nasal spray [ Time Frame: 52 weeks ]


    Original Secondary Outcome: Same as current

    Information By: Katholieke Universiteit Leuven

    Dates:
    Date Received: October 19, 2016
    Date Started: April 2015
    Date Completion: December 2017
    Last Updated: October 19, 2016
    Last Verified: October 2016