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Trial registered on ANZCTR


Registration number
ACTRN12615000093583
Ethics application status
Approved
Date submitted
31/01/2015
Date registered
4/02/2015
Date last updated
4/02/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The impact of Clonidine, a pharmacological treatment for attention deficit hyperactivity disorder (ADHD), on behavioural and brain imaging measures of attention, inhibition and error processing.
Scientific title
A randomised, placebo controlled trial of the effects of Clonidine (200 mcg) on cognitive control and error processing measures (recorded with electroencephalogram (EEG) during behavioural tasks) in a sample of 26 healthy adult males.
Secondary ID [1] 286082 0
Client Id: 13491 (Monash University), protocol Number: 2013001978, Therapeutic good administration (TGA), Australian Govt, Dept of Health - Clinical Trials Notification (CTN) scheme.
Universal Trial Number (UTN)
U1111-1166-7520
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Study employs a commonly used ADHD medication (Clonidine) with healthy human adults (only) and examines changes in behaviours that are of relevance to ADHD (inhibition, error processing, selective attention) 294081 0
Condition category
Condition code
Mental Health 294388 294388 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised placebo controlled trial of the effects of Clonidine (200mcg) on cognitive control and error processing measures in healthy adults.

Clonidine trade name: Catapress

Participants will receive each of Clonidine and placebo in capsule form (1 week apart, order of administration randomised).

The Experimenter will observe ingestion of the capsule (time 0), participants will commence tasks after 90 minutes has elapsed (onset of drug peak), task will be completed at 180 minutes, observation will then occur for half an hour before completion at 210 minutes.
Intervention code [1] 291075 0
Treatment: Drugs
Comparator / control treatment
placebo (cellulose) - trade name: Avicel
mode of administration: capsule
Control group
Placebo

Outcomes
Primary outcome [1] 294176 0
mean stop signal reaction time (SSRT) - a measure of response inhibition
Timepoint [1] 294176 0
At approx 90-180 minutes following placebo vs Clonidine administration
Primary outcome [2] 294177 0
number of errors on error awareness task (EAT)
Timepoint [2] 294177 0
Approximately 90-180 minutes following Placebo vs Clonidine administration
Primary outcome [3] 294178 0
Mean asymmetry measure - spatial asymmetry task
Timepoint [3] 294178 0
At approx 90-180 minutes following placebo vs Clonidine administration
Secondary outcome [1] 312699 0
amplitude of the Error positivity (Pe) - an electrophysiological (EEG) correlate of error awareness (see primary outcome 2)
Timepoint [1] 312699 0
At approx 90-180 minutes following placebo vs Clonidine administration
Secondary outcome [2] 312758 0
amplitude of the Error related negativity (ERN) - an electrophysiological (EEG) correlate of error processing (see primary outcome 2)
Timepoint [2] 312758 0
At approx 90-180 minutes following placebo vs Clonidine administration
Secondary outcome [3] 312760 0
EEG measure of (pre-target) alpha power spatial asymmetry (see primary outcome 3)
Timepoint [3] 312760 0
At approx 90-180 minutes following Placebo vs Clonidine administration

Eligibility
Key inclusion criteria
healthy adult
Normal or corrected to normal vision
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of psychiatric illness
Currently on medication
Smoker
Regular recreational drug use

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)
randomised placebo controlled

allocation concealment via numbered containers (allocation schedule determined by supplier of Clonidine and placebo) and given to experimenters post study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomisation by computer software
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
A repeated measures ANOVA design (drug vs. placebo) will be used to compare the effects of Clonidine (vs placebo) on each of the EEG and behavioural measures

Our previous investigations with similar pharmacological agents
(Methyphenidate, Atomoxetine, Citalopram) revealed effect sizes in the medium to large range with such a design (Cohens D = .5 to .8). see e.g. Nandam et al Biological psychiatry (2011), 69, 902-904.

Given a repeated measures design, effect sizes that fall in the medium/large range, a critical alpha of .05, allowance for multiple comparison correction (and the satisfaction of standard clinical and statistical assumptions for such designs - see below), 26 people will afford us sufficient statistical power (>80%).

clinical assumption:
The subjects (each of whom is an independent sample - eg not related) were correctly assigned to the treatments
Statistical assumption:
the distribution of the difference scores for any given dependent variable should be normal.
We note that if this distribution is non-normal (ie if this assumption is not met) we can run a permutation (distribution free) analysis without any loss of power.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/02/2015
Actual
3/02/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
26
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 290668 0
Government body
Name [1] 290668 0
Australian Research council
Country [1] 290668 0
Australia
Primary sponsor type
Individual
Name
Professor Mark Bellgrove
Address
School of Psychological Sciences
Monash University,
Building 17, Clayton Campus,
Wellington Road,
Monash University, VIC, 3800
Australia
Country
Australia
Secondary sponsor category [1] 289373 0
University
Name [1] 289373 0
Monash University
Address [1] 289373 0
Monash University
Victoria 3800
Australia
Country [1] 289373 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292297 0
Monash University human research ethics committee (MUHREC)
Ethics committee address [1] 292297 0
Ethics committee country [1] 292297 0
Australia
Date submitted for ethics approval [1] 292297 0
Approval date [1] 292297 0
18/12/2013
Ethics approval number [1] 292297 0
CF13/3846 - 2013001978

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

Contacts
Principal investigator
Name 54538 0
Prof Mark Bellgrove
Address 54538 0
School of Psychological Sciences
Monash University,
Building 17, Clayton Campus,
Wellington Road,
Monash University, VIC, 3800
Australia
Country 54538 0
Australia
Phone 54538 0
+61, 3, 99024200
Fax 54538 0
Email 54538 0
mark.bellgrove@monash.edu
Contact person for public queries
Name 54539 0
Mark Bellgrove
Address 54539 0
School of Psychological Sciences
Monash University,
Building 17, Clayton Campus,
Wellington Road,
Monash University, VIC, 3800
Australia
Country 54539 0
Australia
Phone 54539 0
+61, 3, 99024200
Fax 54539 0
Email 54539 0
mark.bellgrove@monash.edu
Contact person for scientific queries
Name 54540 0
Mark Bellgrove
Address 54540 0
School of Psychological Sciences
Monash University,
Building 17, Clayton Campus,
Wellington Road,
Monash University, VIC, 3800
Australia
Country 54540 0
Australia
Phone 54540 0
+61, 3, 99024200
Fax 54540 0
Email 54540 0
mark.bellgrove@monash.edu

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.