Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000564954
Ethics application status
Not yet submitted
Date submitted
31/05/2011
Date registered
2/06/2011
Date last updated
2/06/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Will methylphenidate have an effect on self-control?
Scientific title
In healthy adults, how dose methylphenidate compared with placebo effect cognitive resource depletion and self-control?
Secondary ID [1] 262280 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Self-control 267983 0
Resource depletion in cognitive performance 267997 0
Condition category
Condition code
Mental Health 268115 268115 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single oral dose of methylphenidate (40 mg) capsule and a placebo lactose tablet will be administered to healthy adults to investigate the neurochemical basis of self-control. All participants will receive all conditions of treatment over two separate sessions. The two testing sessions will be separated by at least one week to allow for drug washout. The order in which each participant receives the two treatment conditions is randomised and blinded. No abnormal condition or disease is being investigated as part of this study. The medications in this study are already approved by the Australian Therapeutic Goods Administration.
Intervention code [1] 266672 0
Treatment: Drugs
Comparator / control treatment
Placebo lactose tablets
Control group
Placebo

Outcomes
Primary outcome [1] 266864 0
Resource depletion - when people are given two consecutive tasks that require self-control, they generally perform worse on the second task compared to when participants perform a task that does not require self-control followed by self-control task, suggesting that self-control is a depletable resource. We will measure the participant's cognitive performance using computer tasks following custom designed computer tasks known to induce depletion of self-control. During these tasks participants will be asked to press buttons to visual stimuli (e.g., abstract symbols and objects).
Timepoint [1] 266864 0
1 hour after the administration of methylphenidate or placebo.
Secondary outcome [1] 276520 0
We will use electroencephalography (EEG) to assess neural activity associated with cognitive performance and self-control.
Timepoint [1] 276520 0
1 hour after the administration of methylphenidate or placebo.
Secondary outcome [2] 276547 0
Measures of saliva cortisol levels will be used to establish the relationship between stress and self-control.
Timepoint [2] 276547 0
1 hour after the administration of methylphenidate or placebo.
Secondary outcome [3] 276555 0
Measures of heart rate will be used to establish the relationship between stress and self-control.
Timepoint [3] 276555 0
1 hour after the administration of methylphenidate or placebo.
Secondary outcome [4] 276556 0
Measures of blood pressure will be used to establish the relationship between stress and self-control.
Timepoint [4] 276556 0
1 hour after the administration of methylphenidate or placebo.

Eligibility
Key inclusion criteria
Healthy adults
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Previous personal or first-degree family history of psychiatric or neurological disorders or suicidality, impairments in vision or audition, hepatic or cardiac function (including diagnosed hypertension), pregnancy or breastfeeding, previous intolerance or hypersensitivity to methylphenidate or related medications, current or recent (last 2 weeks) use of psychotropic medication, psychoactive substances or any other medications known to interact with methylphenidate. Participants will also be excluded if their blood pressure is found to be above 140/100 and remains above this level for fifteen minutes.

Study design
Purpose of the study
Diagnosis
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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
All participants will receive all conditions of treatment. The two testing sessions will be separated by at least one week to allow for drug washout. The order in which each participant receives the two treatment conditions is randomised and blinded.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267164 0
Charities/Societies/Foundations
Name [1] 267164 0
John Templeton Foundation
Country [1] 267164 0
United States of America
Primary sponsor type
University
Name
The University of Melbourne
Address
The University of Melbourne, Victoria 3010
Country
Australia
Secondary sponsor category [1] 266239 0
Charities/Societies/Foundations
Name [1] 266239 0
Florey Neuroscience Institutes
Address [1] 266239 0
Level 2, Alan Gilbert Building
161 Barry Street
Carlton South
Victoria 3053, Australia
Country [1] 266239 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 269154 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 269154 0
Ethics committee country [1] 269154 0
Australia
Date submitted for ethics approval [1] 269154 0
29/05/2011
Approval date [1] 269154 0
Ethics approval number [1] 269154 0
2011.117

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

Contacts
Principal investigator
Name 32678 0
Address 32678 0
Country 32678 0
Phone 32678 0
Fax 32678 0
Email 32678 0
Contact person for public queries
Name 15925 0
Olivia Carter
Address 15925 0
Department of Psychological Sciences, The University of Melbourne, Victoria 3010
Country 15925 0
Australia
Phone 15925 0
+61 3 8344 6372
Fax 15925 0
Email 15925 0
[email protected]
Contact person for scientific queries
Name 6853 0
Olivia Carter
Address 6853 0
Department of Psychological Sciences, The University of Melbourne, Victoria 3010
Country 6853 0
Australia
Phone 6853 0
+61 3 8344 6372
Fax 6853 0
Email 6853 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.