A Within-Subject Single Dose Trial on the Effects of Bremelanotide on Social Cognition and Behaviour

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615001059550
• Date of registration: 12/10/2015
• Prospective Registration: Yes
• Primary sponsor: University of Sydney
• Public title: A Within-Subject Single Dose Trial on the Effects of Bremelanotide on Social Cognition and Behaviour
• Scientific title: Do Males Age 16 Years and Older with Autism Spectrum Disorders show an effect of Bremelanotide on Social Cognition and Behaviour?
• Date of first enrolment: 17/11/2015
• Target sample size: 60
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12615001059550.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Crossover;Type of endpoint: Efficacy;
• Phase: Phase 2

Countries of recruitment

Australia

Contacts

• Name: A/Prof Adam Guastella

• Name: Dr Christine Yun Song

Key inclusion & exclusion criteria

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.

Age minimum: 16 Years
Age maximum: 65 Years
Gender: Males

Health Condition(s) or Problem(s) studied

Autism Spectrum Disorder;
Autism Spectrum Disorder

Mental Health - Autistic spectrum disorders

Intervention(s)

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.

Primary Outcome(s)

Correct recognition performance in reading emotions from faces as assess by the eye/faces test[45 minutes after each single dose administration]

Amount of eye gaze to the eyes of faces using Tobi eye tracker [45 minutes after each single dose administration]

Secondary Outcome(s)

Degree of Heart Rate Variability as assess by physiological recording of heart-rate[45 post drug administration]

Correct performance in reading emotion from scenes using movie still task[45 minutes post each single dose administration]

Performance of speed of emotion valence recognition in words using speeded word recognition task comparing social, sexual and control words [45 minutes post administration]

Correct response to inclusion and exclusion toward other players using the 'Social Ball-tossing Game' task.[45 minutes after each single dose administration]

Secondary ID(s)

Nil unknown

Source(s) of Monetary Support

Simons Foundations

Ethics review

Status: Approved
Approval date:
Contact:

University of Sydney