N-of-1 trials of stimulants versus placebo and each other for Attention Deficit Hyperactivity Disorder in children
| ISRCTN | ISRCTN24045888 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24045888 |
| Secondary identifying numbers | ADHDAHMACGEN version 2; Also registered in Australian Clinical Trials Registry: ACTRN12605000507684 |
- Submission date
- 04/08/2007
- Registration date
- 16/08/2007
- Last edited
- 21/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Geoff Mitchell
Scientific
Scientific
Division of General Practice
The University of Queensland
Brisbane
4006
Australia
Study information
| 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 |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | N-of-1 trials of stimulants versus placebo and each other for Attention Deficit Hyperactivity Disorder in children |
| Study acronym | ADHDIMET |
| Study objectives | 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(s) | The University of Queensland Medical Research Ethics Committee and the Mater Misericordiae Hospital Medical Research Ethics Committee approved the study. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Methylphenidate, dexamphetamine |
| Primary outcome measure | 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 study start date | 01/12/1999 |
| Completion date | 01/05/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Not Specified |
| Target number of participants | 100 |
| Total final enrolment | 86 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/1999 |
| Date of final enrolment | 01/05/2005 |
Locations
Countries of recruitment
- Australia
Study participating centre
Division of General Practice
Brisbane
4006
Australia
4006
Australia
Sponsor information
The University of Queensland (Australia)
University/education
University/education
St. Lucia 4029
Brisbane
4029
Australia
| iharris@uq.edu.au | |
| Website | http://www.uq.edu.au/ |
"ROR" |
https://ror.org/00rqy9422 |
Funders
Funder type
Government
General Practice Evaluation Program (GPEP) (Australia)
No information available
The Department of Health and Aged Care (Australia)
No information available
Queensland Medical Laboratory (Australia)
No information available
Mater Misericordiae Health Services (Brisbane, Australia)
No information available
The Royal Australian College of General Practitioners (Australia)
No information available
National Health and Medical Research Council (Australia) - medical postgraduate research scholarship (ref: 210364)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2006 | 21/05/2019 | Yes | No |
Editorial Notes
21/05/2019: Total final enrolment and publication reference added.
