Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001752156
Ethics application status
Approved
Date submitted
2/12/2019
Date registered
10/12/2019
Date last updated
6/08/2021
Date data sharing statement initially provided
10/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the influence of methylphenidate on perceptual decisions in healthy, young adults
Scientific title
Clarifying the role of methylphenidate on distractor processing through event-related potentials in healthy controls.
Secondary ID [1] 297159 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Symptoms of inattention 311316 0
Symptoms of hyperactivity 315542 0
Condition category
Condition code
Mental Health 309950 309950 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Drug Intervention
A single dose of 30mg of methylphenidate will be administered in one testing session via an oral capsule. A gelatin filled placebo capsule will be administered in the second session in a counterbalanced order, with the two sessions separated by 7 days.
Intervention code [1] 313498 0
Treatment: Drugs
Comparator / control treatment
gelatin filled placebo capsule in a counterbalanced, double-blind procedure
Control group
Placebo

Outcomes
Primary outcome [1] 319237 0
Changes to response time in the presence of distractors, assessed through a variation of the random dot motion paradigm
Timepoint [1] 319237 0
1.5-3 hours after administration of drug
Primary outcome [2] 319238 0
Changes to event-related potentials (ERPs) associated with perceptual decisions measured via electroencephalography. Specifically, we will be assessing N2 signals, reflecting early target selection, and the central parietal positivity (CPP), reflecting evidence accumulation. Measured through characteristics of the ERP waveforms (i.e., amplitude, latency and slope).
Timepoint [2] 319238 0
1.5-3 hours after drug administration
Primary outcome [3] 319239 0
Adverse reactions to the drug
- Anxiety - measured through Visual analogue scale and heart rate and blood pressure monitoring
- stomach pain - measured through Visual analogue scale/inquiry from researcher
- sleep problems - measured through Visual analogue scale/inquiry from researcher
- loss of appetite - measured through Visual analogue scale/inquiry from researcher
- nausea - measured through Visual analogue scales/inquiry from researcher
- dizziness - measured through Visual analogue scales/inquiry from researcher
- headache - measured through Visual analogue scale/inquiry from researcher
- increased blood pressure or heart rate - measure through monitoring heart rate and blood pressure
Timepoint [3] 319239 0
At drug administration, 1.5 hours after drug administration, and 3 hours after drug administration.
Secondary outcome [1] 367396 0
Impulsivity, measured through the Barrett Impulsivity Scale (BIS)
Timepoint [1] 367396 0
Measured prior to drug administration
Secondary outcome [2] 367397 0
Inattention symptoms, measured through a subscale of the Conner's Adult ADHD Rating Scale
Timepoint [2] 367397 0
Measured prior to drug administration
Secondary outcome [3] 367398 0
Novelty seeking tendencies, measured through the Tridimensional Personality Questionnaire
Timepoint [3] 367398 0
Measured prior to drug administration
Secondary outcome [4] 367399 0
Genotype of the DAT1 gene, related to dopamine production - measured through saliva collection and DNA analysis
Timepoint [4] 367399 0
Saliva collected prior to drug administration, analysis conducted on completion of data collection
Secondary outcome [5] 367400 0
Exploratory analysis of genes related to noradrenaline production - measured through saliva collection and DNA analysis
Timepoint [5] 367400 0
Saliva collected prior to drug administration, genetic analysis conducted on completion of data collection.
Secondary outcome [6] 377791 0
Hyperactivity symptoms, measured through a subscale of the Conner's Adult ADHD Rating Scale
Timepoint [6] 377791 0
Prior to drug administration.

Eligibility
Key inclusion criteria
All four grandparents Caucasian - to ensure consistency in drug absorption rates
Right handed - to reduce noise associated with differences in organisation of brain function
Females taking combined oral contraceptive pill - to control for any differing absorption rates that may be the result of fluctuating hormones
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Pregnant or breastfeeding - to prevent any potential risk of harm methylphenidate may cause for unborn or newborn children
- History of psychiatric or neurological illness (including head injuries) - such conditions may confound results
- Use of psychotropic medication or significant drug use - could confound results, as any possible alteration in brain function from previous drug use may interfere with substances administered in this study
- Current smokers - May influence sensitivity of nicotine receptors
- Alcohol dependence (more than 24 units/week) - may influence dopamine receptor availability or sensitivity
- Individuals with contraindications to methylphenidate

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)
Randomisation of allocation is done externally through an off-site organisation and concealed to the participants and the researcher until completion of data collection.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2021
Actual
14/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 301712 0
Government body
Name [1] 301712 0
Office of Naval Research Global
Country [1] 301712 0
United States of America
Primary sponsor type
University
Name
Monash University
Address
Wellington Rd, Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 301442 0
Individual
Name [1] 301442 0
Prof Mark Bellgrove
Address [1] 301442 0
School of Psychological Sciences, Monash University, Wellington Rd, Clayton VIC 3800
Country [1] 301442 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302432 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 302432 0
Ethics committee country [1] 302432 0
Australia
Date submitted for ethics approval [1] 302432 0
02/05/2018
Approval date [1] 302432 0
14/06/2018
Ethics approval number [1] 302432 0
13202

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

Contacts
Principal investigator
Name 90222 0
Dr Trevor Chong
Address 90222 0
Monash University, Wellington Road, Clayton, VIC, 3800
Country 90222 0
Australia
Phone 90222 0
+613 9905 9889
Fax 90222 0
Email 90222 0
[email protected]
Contact person for public queries
Name 90223 0
Bridgitt Shea
Address 90223 0
Monash University, Wellington Road, Clayton, VIC, 3800
Country 90223 0
Australia
Phone 90223 0
+613 9905 3997
Fax 90223 0
Email 90223 0
[email protected]
Contact person for scientific queries
Name 90224 0
Trevor Chong
Address 90224 0
Monash University, Wellington Road, Clayton, VIC, 3800
Country 90224 0
Australia
Phone 90224 0
+613 9905 9889
Fax 90224 0
Email 90224 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.