Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000507684
Ethics application status
Approved
Date submitted
15/09/2005
Date registered
26/09/2005
Date last updated
11/09/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can routine N-of-1 studies improve net benefits and reduce costs by better targeting chronic therapy?
Scientific title
Can routine N-of-1 studies improve net benefits and reduce costs by better targeting chronic therapy for Attention Deficit Hyperactivity Disorder?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention Deficit Hyperactivity Disorder. 632 0
Condition category
Condition code
Neurological 704 704 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This single patient (n of 1) trial is a randomised, double-blind, cross-over comparison of methylphenidate and placebo within an individual patient. The patient will undergo three pairs of treatment periods. The order of treatment in each cycle will be determined by random allocation. The choice of initial therapy will be balanced in blocks of four, to ensure that equivalent numbers start the IMET on each of the two medications. Patients, parents and practitioners will all be blinded to which treatment the patients are taking. Product information will be provided to the patient and parent at the beginning of the study.

Parents, teachers, and patients over 12 years will complete ADHD Rating Scales at the end of two days (or one week for the 6 week IMET). If at any time during the study the patient feels worse, that treatment period can be terminated, and they can go on to the next treatment period.

Upon completion of the study, the timing of the active treatment will be revealed. After looking at the symptoms recorded, the doctor and patient decide together whether methylphenidate is of significant benefit. If the patient chooses, they can then continue on that medication, confident that it is effective for them.
Intervention code [1] 624 0
Treatment: Drugs
Comparator / control treatment
Placebo
Control group
Dose comparison

Outcomes
Primary outcome [1] 857 0
To improve therapeutic decision making about Attention Deficit Hyperactivity Disorder (ADHD) medications, by educating the doctor and the patient in the use of Individualised Medication Effectiveness Test methodology for objective individual patient decision making
Timepoint [1] 857 0
Secondary outcome [1] 1720 0
To evaluate individual patient responses to stimulants in terms of relief of ADHD symptoms, and immediate side-effect profile.
Timepoint [1] 1720 0

Eligibility
Key inclusion criteria
Any school age patient with a clinical diagnosis of ADHD of at least a month's duration, made by a medical practitioner, and who is stabilised on treatment with the stimulant. Patient, parent and doctor would like to use the Individualised Medication Effectiveness Test methodology to see if the patient is a responder to the stimulant.
Minimum age
Not stated
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Symptomatic cardiovascular disease. Moderate to severe hypertension. Hyperthyroidism. Phaeochromocytoma. Glaucoma. Agitated states. Anxiety. Motor tics. Tourette syndrome. MAOIs (+/- 14 days). Idiosyncratic reaction to sympathomimetic amines. History of drug abuse.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
7/08/2000
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
108
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 779 0
Government body
Name [1] 779 0
Australian Health Ministers' Advisory Council
Country [1] 779 0
Australia
Funding source category [2] 780 0
Government body
Name [2] 780 0
Mater Health Services, Brisbane
Country [2] 780 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 645 0
Hospital
Name [1] 645 0
Mater Health Services, Brisbane
Address [1] 645 0
Country [1] 645 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2054 0
University of Queensland
Ethics committee address [1] 2054 0
Ethics committee country [1] 2054 0
Australia
Date submitted for ethics approval [1] 2054 0
Approval date [1] 2054 0
Ethics approval number [1] 2054 0
Ethics committee name [2] 2055 0
Mater Health Services
Ethics committee address [2] 2055 0
Ethics committee country [2] 2055 0
Australia
Date submitted for ethics approval [2] 2055 0
Approval date [2] 2055 0
Ethics approval number [2] 2055 0
Ethics committee name [3] 2056 0
Princess Alexandra Hospital
Ethics committee address [3] 2056 0
Ethics committee country [3] 2056 0
Australia
Date submitted for ethics approval [3] 2056 0
Approval date [3] 2056 0
Ethics approval number [3] 2056 0
Ethics committee name [4] 2057 0
Port Kembla Hospital
Ethics committee address [4] 2057 0
Ethics committee country [4] 2057 0
Australia
Date submitted for ethics approval [4] 2057 0
Approval date [4] 2057 0
Ethics approval number [4] 2057 0
Ethics committee name [5] 2058 0
Princess Margaret Hospital
Ethics committee address [5] 2058 0
Ethics committee country [5] 2058 0
Australia
Date submitted for ethics approval [5] 2058 0
Approval date [5] 2058 0
Ethics approval number [5] 2058 0
Ethics committee name [6] 2059 0
Royal Children's Hospital
Ethics committee address [6] 2059 0
Ethics committee country [6] 2059 0
Australia
Date submitted for ethics approval [6] 2059 0
Approval date [6] 2059 0
Ethics approval number [6] 2059 0

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

Contacts
Principal investigator
Name 35713 0
Address 35713 0
Country 35713 0
Phone 35713 0
Fax 35713 0
Email 35713 0
Contact person for public queries
Name 9813 0
Norma McNairn
Address 9813 0
Individualised Medication Effectiveness Test (IMET) Service
University of Queensland
Level 2 Edith Cavell Building
Herston QLD 4006
Country 9813 0
Australia
Phone 9813 0
+61 7 33464835
Fax 9813 0
+61 7 33655130
Email 9813 0
[email protected]
Contact person for scientific queries
Name 741 0
Associate Professor Geoff Mitchell
Address 741 0
School of Medicine
University of Queensland
Herston Rd
Herston QLD 4006
Country 741 0
Australia
Phone 741 0
+61 7 33655504
Fax 741 0
+61 7 33655130
Email 741 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.