Please be advised that due to the high volume of submissions, the ANZCTR is currently experiencing delays in processing submissions. Please allow additional time for registration or updates to registration records. As the ANZCTR is funded by Australia and New Zealand, we must prioritise submissions from these countries first, therefore international submissions will experience further delays. Apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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

Study type
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

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

Key inclusion criteria
Minimum age
18 Years
Maximum age
65 Years
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

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

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

Ethics approval
Ethics application status
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
Date submitted for ethics approval [1] 5950 0
Approval date [1] 5950 0
Ethics approval number [1] 5950 0

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

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
Phone 12112 0
Fax 12112 0
Email 12112 0
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
Phone 3040 0
(08) 9347-6443
Fax 3040 0
(08) 9346-3469
Email 3040 0

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