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Trial registered on ANZCTR


Registration number
ACTRN12608000610336
Ethics application status
Approved
Date submitted
19/09/2008
Date registered
5/12/2008
Date last updated
5/12/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dexamphetamine modulation of brainwave activity and prepulse inhibition in healthy participants
Scientific title
Dexamphetamine modulation of brainwave activity and prepulse inhibition in healthy participants
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 3720 0
Condition category
Condition code
Mental Health 3891 3891 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
0.45 mg/kg (oral) dose of dexamphetamine administered once
Intervention code [1] 3432 0
Treatment: Drugs
Comparator / control treatment
placebo (oral glucose capsule) administered once. This is a cross-over trial with a
minimum wash-out between drug and placebo is 5 days, maximum washout is 14 days, mode (most frequent) wash-out is 7 days.
Control group
Placebo

Outcomes
Primary outcome [1] 4791 0
Prepulse Inhibition of the Acoustic Startle Response
Timepoint [1] 4791 0
90-120 min
Primary outcome [2] 4792 0
Change in P300 Event-Related Potential (EEG)
Timepoint [2] 4792 0
210 min
Secondary outcome [1] 8086 0
Saliva dexamphetamine level
Timepoint [1] 8086 0
0, 90, 150, 240, 300 min
Secondary outcome [2] 8087 0
Plasma dexamphetamine level
Timepoint [2] 8087 0
90 min

Eligibility
Key inclusion criteria
healthy
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Pregnancy or currently breastfeeding
2. hearing disorders
3. neurological disorders or known seizure risk
4. history of loss of consciousness for over 15 min
5. current diagnosis or treatment for a mental illness
6. past or current treatment for substance use disorder
7. significant risk of psychosis
8. presence or history of a kinetic disorder
9. presence or history of hypertension
10. presence or history of hepatic insufficiency
11. presence renal insufficiency
12. presence or history of cardiovascular disorder
13. significant risk of suicide
14. known hypersensitivity to amphetamines
15. receiving any systemic prescription medication (excluding contraceptives)

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)
This is a within-subject treatment design (AB) where the order of treatment (placebo or drug) is randomised. The person who determines eligibility for inclusion in the trial is unaware of the treatment being allocated on the day of assessment and medical examination. Allocation of order of treatment was randomised by the Participant is provided information on the study and by an experimenter who is blind to the allocation. Interview and medical examination and decision to include or exclude from the study is conducted by one of two Psychiatrists who are unaware of the allocation to treatment schedule. initial contact Chief Investigator (MMI) off-site with a random number table, who does not assess the participants' suitability, does not test the participants, or analyse the data.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation of treatment order by random number table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3899 0
University
Name [1] 3899 0
University of Western Australia
Address [1] 3899 0
35 Stirling Highway
Crawley, WA 6009
Country [1] 3899 0
Australia
Primary sponsor type
Individual
Name
Mathew Martin-Iverson
Address
University of Western Australia
35 Stirling Highway, Crawley, WA 6009
Country
Australia
Secondary sponsor category [1] 3500 0
Individual
Name [1] 3500 0
Joseph Lee
Address [1] 3500 0
Graylands Hospital,
Brockway Road
Mt Claremont, WA 6600
Country [1] 3500 0
Australia
Other collaborator category [1] 423 0
Individual
Name [1] 423 0
Rajan Iyyalol
Address [1] 423 0
Graylands Hospital
Brockway Road
Mt Claremont, WA 6600
Country [1] 423 0
Australia
Other collaborator category [2] 449 0
Individual
Name [2] 449 0
Rajan Iyyalol
Address [2] 449 0
Graylands Hospital,
Brockway Road
Mt Claremont, WA 6600
Country [2] 449 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5950 0
University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 5950 0
35 Stirling Highway
Crawley, WA 6009
Ethics committee country [1] 5950 0
Australia
Date submitted for ethics approval [1] 5950 0
Approval date [1] 5950 0
26/03/2008
Ethics approval number [1] 5950 0
RA/4/1/1987

Summary
Brief summary
The primary purpose of the study is to determine whether or not acute administration of amphetamine produces schizophrenic-like brain function and cognitive effects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28955 0
Address 28955 0
Country 28955 0
Phone 28955 0
Fax 28955 0
Email 28955 0
Contact person for public queries
Name 12112 0
Mathew Martin-Iverson
Address 12112 0
University of Western Australia
Pharmacology M510,
35 Stirling Highway,
Crawley, WA 6009
Country 12112 0
Australia
Phone 12112 0
(08)-9347-6443
Fax 12112 0
(08)-9346-3469
Email 12112 0
mathew.martin-iverson@uwa.edu.au
Contact person for scientific queries
Name 3040 0
Mathew Martin-Iverson
Address 3040 0
University of Western Australia
Pharmacology M510,
35 Stirling Highway,
Crawley, WA 6009
Country 3040 0
Australia
Phone 3040 0
(08) 9347-6443
Fax 3040 0
(08) 9346-3469
Email 3040 0
mathew.martin-Iverson@uwa.edu.au

No information has been provided regarding IPD availability
Summary results
No Results