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

Do healthy males aged 18 years and older show an effect of Bremelanotide on social cognition and behaviour?

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615001033538

Enrollment

Registered

2015-10-01

Start date

2015-10-01

Completion date

2017-10-02

Last updated

2021-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this proposal is to conduct the first study of the impact of subcutaneous injection of PT-141 on key mechanisms involved in social communication in healthy adults. 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

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

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

Participants must meet the criteria of good health through the SCID-IV-TR screener and must not meet the criteria for Autistic Disorder, Pervasive Developmental Disorder-Not Otherwise Specified or Asperger's Disorder.

Exclusion criteria

Healthy participants will be excluded if they meet the following exclusion criteria: Severe depression with suicidal thought/s 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