None listed
Conditions
Brief summary
The aim of this proposal is to conduct the first study of the impact of subcutaneous administration of PT-141 on key mechanisms involved in social communication in adults with autism. We hypothesize that PT-141 will, in comparison to an identical and matched placebo: increase gaze duration and fixations to key face regions, improve accuracy and the speed of identification of facial emotion recognition, increase heart rate variability, and improve accuracy of response to social cues.
Interventions
Participants receive both treatments in a random order. Participants are randomised to receive either a single dose subcutaneous injection of 1.75mg of PT-141 or Placebo, followed by a two week wash-out period and then a single dose subcutaneous injection of 1.75mg of PT-141 or placebo. Participants will have exposure to the PT-141 drug within the research premises here in the Brain and Mind Centre, University of Sydney. They are not allowed to go outside the research premises while the drug is active, which will take 45 minutes from drug administration.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
16 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Participants must meet DSM-IV-TR criteria for Autistic Disorder, Pervasive Developmental Disorder-Not Otherwise Specified or Asperger’s Disorder.
Exclusion criteria
Clinical participants will be excluded if they meet the following exclusion criteria: Severe depression with suicidal thought/and or actions, High blood pressure, Severe cardiovascular problems, Kidney disease, Psychosis, Addiction to nicotine and/or illicit substances. Concomitant medications that exclude participants: use of phosphodiesterase type 5 inhibitor (e.g., erectile dysfunction) medications.
Outcome results
None listed