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

Phase 2

Completed

• Conditions: one; None; Mental Health - Studies of normal psychology, cognitive function and behaviour

• Registration Number: ACTRN12615001033538
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-01
• Study Completion: 2017-10-20
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 61

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correct recognition performance in reading emotions from faces as assessed by the eyes and 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 Measures

Name	Time	Method
Correct response to inclusion and exclusion toward other players using the 'Social Ball-tossing Game' task.[45 minutes after each single dose administration];Degree of Heart Rate Variability as assess by physiological recording of heart-rate[45 minutes post drug administration];Correct performance in reading emotion from scenes using movie still task[2 hours post drug administration];Correct performance in reading emotion from movie scenes[45 minutes post drug 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]