Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000432011
Ethics application status
Approved
Date submitted
20/05/2010
Date registered
27/05/2010
Date last updated
12/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of atomoxetine for adults with Attention Deficit Hyperactivity Disorder (ADHD)
Scientific title
A randomised controlled trial of atomoxetine vs placebo for attentional lapses in adults with attention deficit hyperactivity disorder (ADHD)
Secondary ID [1] 251824 0
NA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention deficit hyperactivity disorder 257423 0
Condition category
Condition code
Mental Health 257570 257570 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Atomoxetine capsules (daily dose ranging from 60mg-120mg) for 10 weeks. Starting dose is 60mg daily for all participants. Dose may be increased after 2 weeks to 90mg or 120 mg depending on individual clinical response as judged by clinical assessment and rating scales.
Intervention code [1] 256525 0
Treatment: Drugs
Comparator / control treatment
Identical looking placebo capsules daily for 10 weeks (microcellulose capsule)
Control group
Placebo

Outcomes
Primary outcome [1] 258489 0
Continuous Temporal Expectancy Task
Timepoint [1] 258489 0
Baseline and 10 weeks
Primary outcome [2] 258490 0
Stop Signal Task
Timepoint [2] 258490 0
Baseline and 10 weeks
Primary outcome [3] 258491 0
Spatial N-Back
Timepoint [3] 258491 0
Baseline and 10 weeks
Secondary outcome [1] 264277 0
Contingent Capture Task
Timepoint [1] 264277 0
Baseline and 10 weeks
Secondary outcome [2] 264278 0
Motor response reward task
Timepoint [2] 264278 0
Baseline and 10 weeks
Secondary outcome [3] 264279 0
Connors Adult ADHD Rating Scale
Timepoint [3] 264279 0
Baseline, 2, 4, 6, 8 and 10 weeks
Secondary outcome [4] 264280 0
Sheehan Disability Scale
Timepoint [4] 264280 0
Baseline and 10 weeks
Secondary outcome [5] 264281 0
State-trait anxiety inventory
Timepoint [5] 264281 0
Baseline and 10 weeks
Secondary outcome [6] 264282 0
Beck Depression Inventory
Timepoint [6] 264282 0
Baseline and 10 weeks
Secondary outcome [7] 264283 0
State-trait anger inventory
Timepoint [7] 264283 0
Baseline and 10 weeks

Eligibility
Key inclusion criteria
Aged at least 18 years
Diagnosis of ADHD
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Current or past diagnosis of psychotic disorders, pervasive development disorders, intellectual impairment,
2. History of serious neurologic illnesses including stroke, brain tumours, head trauma, multiple sclerosis, epilepsy, movement disorders or migraine in treatment
3. drug dependency on alcohol or illicit substances
4. Pregnancy or breast feeding

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)
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
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
68
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257009 0
Commercial sector/Industry
Name [1] 257009 0
Eli Lilly
Country [1] 257009 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Brisbane QLD 4072
Country
Australia
Secondary sponsor category [1] 256271 0
None
Name [1] 256271 0
Address [1] 256271 0
Country [1] 256271 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Atomoxetine is an established treatment for ADHD. Despite its routine use, little is understood how it influences brain functioning. This study will test the effect of atomoxetine treatment on a range of brain functions relevant to ADHD.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31199 0
Address 31199 0
Country 31199 0
Phone 31199 0
Fax 31199 0
Email 31199 0
Contact person for public queries
Name 14446 0
Angela Dean
Address 14446 0
The Queensland Brain Institute
QBI Building (#79)
Upland Rd
The University of Queensland
St Lucia, QLD 4072
Country 14446 0
Australia
Phone 14446 0
+61 7 3346 3325
Fax 14446 0
Email 14446 0
[email protected]
Contact person for scientific queries
Name 5374 0
Angela Dean
Address 5374 0
The Queensland Brain Institute
QBI Building (#79)
Upland Rd
The University of Queensland
St Lucia, QLD 4072
Country 5374 0
Australia
Phone 5374 0
+61 7 3346 3325
Fax 5374 0
Email 5374 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.