Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000357954
Ethics application status
Not yet submitted
Date submitted
4/04/2011
Date registered
6/04/2011
Date last updated
6/04/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Tyrosine supplementation in preventing the cognitive effects of psychosocial stress
Scientific title
Tyrosine supplementation versus placebo in preventing the cognitive effects of psychosocial stress in healthy adults
Secondary ID [1] 259917 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 265524 0
Condition category
Condition code
Mental Health 265681 265681 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Once off administration of an oral solution containing either the natural amino acid tyrosine (at a dose of either 100mg/kg or 200mg/kg) or a placebo to healthy adult (male and female) volunteers, two hours prior to exposure to psychosocial stressor (Trier Social Stress Test). To be administered randomly and in a blinded manner
Intervention code [1] 264340 0
Treatment: Drugs
Intervention code [2] 264351 0
Prevention
Comparator / control treatment
Placebo (i.e. oral glucose solution)
Control group
Placebo

Outcomes
Primary outcome [1] 266458 0
Change in neurocognition as measured by neurocogntive tests battery including simple and choice reaction time, verbal episodic memory, groton maze learning task
Timepoint [1] 266458 0
To be measured during one day of testing - at baseline, immediately following administration of Trier Social Stress Test and again one hour later
Secondary outcome [1] 273813 0
Change in biochemical markers of stress (salivary cortisol and alpha-amylase) and central dopamine activity (serum prolactin)
Timepoint [1] 273813 0
To be measured during one day of testing - at baseline, immediately pre- and post-administration of Trier Social Stress Test and again one hour later

Eligibility
Key inclusion criteria
Healthy adult volunteers
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Past or present mental illness
Family history of mental illness
Any medication or illicit substance use
Pregnant

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealed through the use of an "off-site" allocation schedule. The holder of the schedule contacted following enrollment of a subject
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by a computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264803 0
Government body
Name [1] 264803 0
National Health and Medical Research Council
Country [1] 264803 0
Australia
Primary sponsor type
Individual
Name
Dr Lanny Bochsler
Address
Department of Psychiatry
University of Melbourne
Austin Health
145 Studley Rd
Heidelberg Victoria 3084
Country
Australia
Secondary sponsor category [1] 263915 0
None
Name [1] 263915 0
Address [1] 263915 0
Country [1] 263915 0
Other collaborator category [1] 251926 0
Individual
Name [1] 251926 0
Associate Professor James Olver
Address [1] 251926 0
Department of Psychiatry
University of Melbourne
Austin Health
145 Studley Rd
Heidelberg Victoria 3084
Country [1] 251926 0
Australia
Other collaborator category [2] 251927 0
Individual
Name [2] 251927 0
Associate Professor Trevor Norman
Address [2] 251927 0
Department of Psychiatry
University of Melbourne
Austin Health
145 Studley Rd
Heidelberg Victoria 3084
Country [2] 251927 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 266780 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 266780 0
Ethics committee country [1] 266780 0
Australia
Date submitted for ethics approval [1] 266780 0
16/03/2011
Approval date [1] 266780 0
Ethics approval number [1] 266780 0
EC00204

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

Contacts
Principal investigator
Name 32438 0
Address 32438 0
Country 32438 0
Phone 32438 0
Fax 32438 0
Email 32438 0
Contact person for public queries
Name 15685 0
Ann Pisarevsky
Address 15685 0
Department of Psychiatry
University of Melbourne
Austin Health
145 Studley Rd
Heidelberg Victoria 3084
Country 15685 0
Australia
Phone 15685 0
+61 3 94965000
Fax 15685 0
Email 15685 0
[email protected]
Contact person for scientific queries
Name 6613 0
Dr Lanny Bochsler
Address 6613 0
Department of Psychiatry
University of Melbourne
Austin Health
145 Studley Rd
Heidelberg Victoria 3084
Country 6613 0
Australia
Phone 6613 0
+61 3 94965000
Fax 6613 0
Email 6613 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.