Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000603910
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 scopolamine improve attention more than placebo in healthy volunteers and what does this tell us about mechanisms of attention?
Scientific title
Does scopolamine improve selective attention and cognition more than placebo in healthy male volunteers?
Secondary ID [1] 262357 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Normal attention and cognitive functioning 268059 0
Condition category
Condition code
Neurological 268203 268203 0 0
Studies of the normal brain and nervous system
Mental Health 268208 268208 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single dose of scopolamine (0.8mg contained in one capsule)
(1-2 week washout between conditions)
Intervention code [1] 266749 0
Treatment: Drugs
Comparator / control treatment
A single of dose of placebo (identical capsule)
(1-2 week washout between conditions)
Control group
Placebo

Outcomes
Primary outcome [1] 266941 0
Attentional processing measured using an EEF paradigm quantifying Steady State Visual Evoked Potentials
Timepoint [1] 266941 0
Measured one hour after drug administration
Primary outcome [2] 266942 0
Spatial attention using a Contingent Capture task
Timepoint [2] 266942 0
Measured one hour after drug administration
Secondary outcome [1] 276667 0
Nil
Timepoint [1] 276667 0
Nil

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 diagnosis
Current use of psychotropic medication
Current use of cholinergic or anticholinergic medication
Medical condition in which scopolamine is contraindicated

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
Phase 4
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
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267235 0
University
Name [1] 267235 0
The Queensland Brain Institute
Country [1] 267235 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Mark Bellgrove
The Queensland Brain Institute
Building #79, Upland Rd
The University of Queensland
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 266300 0
None
Name [1] 266300 0
Address [1] 266300 0
Country [1] 266300 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Attentional processing is a cognitive skill that allows us to interpret and act in our environment. Although this skill is important, little is understoond about the neurochemical processes that are important to attention. This study will allow us to assess the importance of different brain chemicals in contributing to selective attention function.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32729 0
Address 32729 0
Country 32729 0
Phone 32729 0
Fax 32729 0
Email 32729 0
Contact person for public queries
Name 15976 0
Angela Dean
Address 15976 0
The Queensland Brain Institute
Building #79, Upland Rd
The University of Queensland
St Lucia QLD 4072
Country 15976 0
Australia
Phone 15976 0
+61 7 3346 3325
Fax 15976 0
Email 15976 0
[email protected]
Contact person for scientific queries
Name 6904 0
Angela Dean
Address 6904 0
The Queensland Brain Institute
Building #79, Upland Rd
The University of Queensland
St Lucia QLD 4072
Country 6904 0
Australia
Phone 6904 0
+61 7 3346 3325
Fax 6904 0
Email 6904 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.