Condition category
Mental and Behavioural Disorders
Date applied
04/08/2007
Date assigned
16/08/2007
Last edited
04/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Geoff Mitchell

ORCID ID

Contact details

Division of General Practice
The University of Queensland
Brisbane
4006
Australia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ADHDAHMACGEN version 2; Also registered in Australian Clinical Trials Registry: ACTRN12605000507684

Study information

Scientific title

Acronym

ADHDIMET

Study hypothesis

1. N-of-1 trials will improve therapeutic decision making about Attention Deficit Hyperactivity Disorder (ADHD) medications, by educating the doctor and the patient in the use of N-of-1 trial methodology for objective individual patient decision making
2. N-of-1 trials will be able to evaluate individual patient responses to stimulants in terms of relief of ADHD symptoms, and immediate side-effect profile

Ethics approval

The University of Queensland Medical Research Ethics Committee and the Mater Misericordiae Hospital Medical Research Ethics Committee approved the study.

Study design

This N-of-1 trial is a randomised, double-blind, cross-over comparison of stimulants (methylphenidate or dexamphetamine) and placebo within an individual patient.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Attention Deficit Hyperactivity Disorder

Intervention

1. Stimulant versus placebo
2. Stimulant versus stimulant

The stimulants being tested will be dexamphetamine and methylphenidate, compared to placebo and each other. The dose will be individualised by the child's doctor to the optimum dose without side effects, and will be taken orally at morning and lunchtime. There are two types of trials: treatments will take place in three day or one week periods; each pair of periods will be repeated three times (total of 3 and 6 weeks respectively). Follow-up will be for one year.

Intervention type

Drug

Phase

Not Specified

Drug names

Methylphenidate, dexamphetamine

Primary outcome measures

1. Conners' Teacher and Parent self reported revised short form
2. Conners-Wells Adolescent Rating Scales

Outcomes will be measured at baseline and at the end of each treatment period.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/12/1999

Overall trial end date

01/05/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Any school age patient with a clinical diagnosis of ADHD of at least a month's duration, in the opinion of the attending medical practitioner, who is stabilised on treatment with Ritalin
2. Patient, parent and doctor would like to use the n-of-1 trial methodology to see if the patient is a responder to methylphenidate or dexamphetamine

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

100

Participant exclusion criteria

1. Advanced arteriosclerosis
2. Symptomatic cardiovascular disease
3. Moderate to severe hypertension
4. Hyperthyroidism
5. Phaeochromocytoma
6. Glaucoma
7. Agitated states
8. Anxiety
9. Motor tics
10. Tourette syndrome
11. Monoamine Oxidase Inhibitors (MAOIs) (+/- 14 days)
12. Idiosyncratic reaction to sympathomimetic amines
13. History of drug abuse

Recruitment start date

01/12/1999

Recruitment end date

01/05/2005

Locations

Countries of recruitment

Australia

Trial participating centre

Division of General Practice
Brisbane
4006
Australia

Sponsor information

Organisation

The University of Queensland (Australia)

Sponsor details

St. Lucia 4029
Brisbane
4029
Australia
iharris@uq.edu.au

Sponsor type

University/education

Website

http://www.uq.edu.au/

Funders

Funder type

Government

Funder name

General Practice Evaluation Program (GPEP) (Australia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Department of Health and Aged Care (Australia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Queensland Medical Laboratory (Australia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Mater Misericordiae Health Services (Brisbane, Australia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Royal Australian College of General Practitioners (Australia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Health and Medical Research Council (Australia) - medical postgraduate research scholarship (ref: 210364)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes