Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001033538
Ethics application status
Approved
Date submitted
14/09/2015
Date registered
1/10/2015
Date last updated
31/03/2021
Date data sharing statement initially provided
31/03/2021
Date results information initially provided
31/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A Within-Subject Single Dose Trial on the Effects of Bremelanotide on Social Cognition
Scientific title
Do healthy males aged 18 years and older show an effect of Bremelanotide on social cognition and behaviour?
Secondary ID [1] 287467 0
Nil unknown
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
None 296195 0
Condition category
Condition code
Mental Health 296471 296471 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 292843 0
Treatment: Drugs
Comparator / control treatment
Single dose subcutaneous injection of 1.75mg of placebo. The placebo is composed of 2.5% (w/v) glycerin (United States Pharmacopoeia [USP], multi-compendial, vegetable-grade) in sterile water for injection, USP, adjusted to pH 5.0 with either hydrochloric acid or sodium hydroxide as necessary.
Control group
Placebo

Outcomes
Primary outcome [1] 296099 0
Correct recognition performance in reading emotions from faces as assessed by the eyes and faces test
Timepoint [1] 296099 0
45 minutes after each single dose administration
Primary outcome [2] 296100 0
Amount of eye gaze to the eyes of faces using Tobi eye tracker
Timepoint [2] 296100 0
45 minutes after each single dose administration
Secondary outcome [1] 317499 0
Correct response to inclusion and exclusion toward other players using the 'Social Ball-tossing Game' task.
Timepoint [1] 317499 0
45 minutes after each single dose administration
Secondary outcome [2] 317500 0
Degree of Heart Rate Variability as assess by physiological recording of heart-rate
Timepoint [2] 317500 0
45 minutes post drug administration
Secondary outcome [3] 317501 0
Correct performance in reading emotion from scenes using movie still task
Timepoint [3] 317501 0
2 hours post drug administration
Secondary outcome [4] 317502 0
Correct performance in reading emotion from movie scenes
Timepoint [4] 317502 0
45 minutes post drug administration
Secondary outcome [5] 317997 0
Performance of speed of emotion valence recognition in words using speeded word recognition task comparing social, sexual and control words
Timepoint [5] 317997 0
45 minutes post-administration

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants are assigned to sequential treatment packs labelled with a unique study number. Neither participants nor research staff will be aware of the group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation follows a computer-generated randomisation schedule with balanced variable blocks, prepared by the pharmacist. Each pre-packed treatment contains one active and one identical and matched subcutaneous injection. The pharmacist will hold the randomisation code.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/10/2015
Date of last participant enrolment
Anticipated
4/09/2016
Actual
2/10/2017
Date of last data collection
Anticipated
Actual
20/10/2017
Sample size
Target
61
Accrual to date
Final
61
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 10483 0
2050 - Camperdown
Recruitment postcode(s) [2] 10484 0
2046 - Abbotsford
Recruitment postcode(s) [3] 10485 0
2131 - Ashfield
Recruitment postcode(s) [4] 10486 0
2041 - Balmain
Recruitment postcode(s) [5] 10487 0
2137 - North Strathfield
Recruitment postcode(s) [6] 10488 0
2132 - Croydon
Recruitment postcode(s) [7] 10489 0
2042 - Newtown
Recruitment postcode(s) [8] 10490 0
2040 - Leichhardt
Recruitment postcode(s) [9] 10491 0
2045 - Haberfield
Recruitment postcode(s) [10] 10492 0
2204 - Marrickville
Recruitment postcode(s) [11] 10493 0
2130 - Summer Hill
Recruitment postcode(s) [12] 10494 0
2007 - Broadway
Recruitment postcode(s) [13] 10495 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 292040 0
Charities/Societies/Foundations
Name [1] 292040 0
Simons Foundations
Country [1] 292040 0
United States of America
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney, College Street, University of Sydney, NSW 2006
Country
Australia
Secondary sponsor category [1] 290711 0
None
Name [1] 290711 0
Address [1] 290711 0
Country [1] 290711 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293524 0
University of Sydney
Ethics committee address [1] 293524 0
The University of Sydney, Margaret Telfer Building (K07), University of Sydney, NSW 2006
Ethics committee country [1] 293524 0
Australia
Date submitted for ethics approval [1] 293524 0
Approval date [1] 293524 0
28/11/2013
Ethics approval number [1] 293524 0
2012/2816

Summary
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.
Trial website
Trial Completed.
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60310 0
A/Prof Adam Guastella
Address 60310 0
Brain and Mind Centre, 100 Mallett Street, Camperdown, NSW 2050
Country 60310 0
Australia
Phone 60310 0
+61 2 9351 0539
Fax 60310 0
Email 60310 0
[email protected]
Contact person for public queries
Name 60311 0
Prof Adam Guastella
Address 60311 0
Brain and Mind Centre, 94 Mallett Street, Camperdown, NSW, 2050
Country 60311 0
Australia
Phone 60311 0
+61 2 9114 4104
Fax 60311 0
Email 60311 0
[email protected].,au
Contact person for scientific queries
Name 60312 0
A/Prof Adam Guastella
Address 60312 0
Brain and Mind Centre, 100 Mallett Street, Camperdown, NSW 2050
Country 60312 0
Australia
Phone 60312 0
+61 2 9351 0539
Fax 60312 0
Email 60312 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.