Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000604909
Ethics application status
Approved
Date submitted
10/06/2011
Date registered
10/06/2011
Date last updated
10/06/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Does cabergoline improve cognition and attention more than placebo in healthy volunteers and what does this tell us about mechanisms of attention?
Scientific title
A randomised controlled trial comparing the effects of cabergoline vs placebo on executive control in healthy male volunteers
Secondary ID [1] 262356 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Executive control in healthy volunteers 268058 0
Condition category
Condition code
Mental Health 268201 268201 0 0
Studies of normal psychology, cognitive function and behaviour
Neurological 268202 268202 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single dose of cabergoline (oral capsule containing 1.25mg)
(1-2 week washout period between conditions)
Intervention code [1] 266748 0
Treatment: Drugs
Comparator / control treatment
A single dose of an identical looking placebo capsule
(1-2 week washout period between conditions)
Control group
Placebo

Outcomes
Primary outcome [1] 266939 0
Response inhibition measured using the Stop Signal Task
Timepoint [1] 266939 0
1 hour following administration of capsule
Primary outcome [2] 266940 0
Error awareness using the Error Awareness Task (EAT)
Timepoint [2] 266940 0
1 hour following administration of capsule
Secondary outcome [1] 276666 0
Spatial attention measured with two tasks, the Attention-Competition Task and the Grey-Scales Task
Timepoint [1] 276666 0
1 hour following administration of capsule

Eligibility
Key inclusion criteria
Healthy volunteers
Aged 18 -40 years
Male
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Current psychiatric or neurological illness
Current use of psychotropic medication
CUrrent substance use or dependence
Medical illness that is a contraindication for cabergoline use

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267234 0
University
Name [1] 267234 0
The Queensland Brain Institute
Country [1] 267234 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The Queensland Brain Institute
Building #79, Upland Rd
The University of Queensland
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 266299 0
None
Name [1] 266299 0
Address [1] 266299 0
Country [1] 266299 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32728 0
Address 32728 0
Country 32728 0
Phone 32728 0
Fax 32728 0
Email 32728 0
Contact person for public queries
Name 15975 0
Angela Dean
Address 15975 0
The Queensland Brain Institute
Building #79, Upland Rd
The University of Queensland
St Lucia QLD 4072
Country 15975 0
Australia
Phone 15975 0
+61 7 3346 3325
Fax 15975 0
Email 15975 0
[email protected]
Contact person for scientific queries
Name 6903 0
Angela Dean
Address 6903 0
The Queensland Brain Institute
Building #79, Upland Rd
The University of Queensland
St Lucia QLD 4072
Country 6903 0
Australia
Phone 6903 0
+61 7 3346 3325
Fax 6903 0
Email 6903 0
[email protected]

No information has been provided regarding IPD availability


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.