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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00760747




Registration number
NCT00760747
Ethics application status
Date submitted
25/09/2008
Date registered
26/09/2008
Date last updated
1/09/2011

Titles & IDs
Public title
Comparison of Slow and Fast Transition From Stimulants to Atomoxetine in Children and Adolescents With Attention Deficit/Hyperactivity Disorder(ADHD)
Scientific title
A Randomized, Controlled, Open-Label Comparison Study of the Efficacy and Safety of Slow Transitioning Compared With Fast Transitioning From a Stimulant Medication to Atomoxetine in Pediatric and Adolescent Outpatients With DSM-IV Attention-Deficit/Hyperactivity Disorder (ADHD)
Secondary ID [1] 0 0
B4Z-EW-LYFJ
Secondary ID [2] 0 0
12305
Universal Trial Number (UTN)
Trial acronym
ADHD SWITCH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention Deficit Hyperactivity Disorder 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Atomoxetine

Experimental: Slow Switching Group - Slow Switching Group (switch from full stimulant dose to atomoxetine, 1.2 mg/kg/day, orally (PO), during 10 weeks then continue treatment up to 1.8 mg/kg/day, PO to 14 weeks

Experimental: Fast Switching Group - Fast Switching Group (switch from full stimulant dose to atomoxetine 1.2 mg/kg/day, PO, during 2 weeks then continue treatment up to 1.8 mg/kg/day, PO to 14 weeks


Treatment: Drugs: Atomoxetine
1.2 mg/kg/day up to 1.8 mg/kg/day, orally (PO)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Attention Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS-IV) Parent Version: Investigator Administered and Scored - Total Score at Week 10 Endpoint
Timepoint [1] 0 0
Baseline, 10 weeks
Primary outcome [2] 0 0
Change From Baseline in ADHD-RS-IV Parent Version: Investigator Administered and Scored - Total Score at Week 2 Endpoint
Timepoint [2] 0 0
Baseline, 2 weeks
Secondary outcome [1] 0 0
Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale - Patient Total Score at Week 10 Endpoint
Timepoint [1] 0 0
Baseline, 10 weeks
Secondary outcome [2] 0 0
Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Parent Total Score at Week 10 Endpoint
Timepoint [2] 0 0
Baseline, 10 weeks
Secondary outcome [3] 0 0
Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Investigator Total Score at Week 10 Endpoint
Timepoint [3] 0 0
Baseline, 10 weeks
Secondary outcome [4] 0 0
Change From Baseline in Clinical Global Impression Severity (CGI-S) Rating Scale - Total Score at Week 10 Endpoint
Timepoint [4] 0 0
Baseline, 10 weeks
Secondary outcome [5] 0 0
Change From Baseline in Child Health and Illness Profile Child Edition-Parent Report Form (CHIP-CE-PRF) - Domain Scores at Week 10 Endpoint
Timepoint [5] 0 0
Baseline, 10 weeks
Secondary outcome [6] 0 0
Change From Baseline in Treatment Satisfaction Preference Survey Mean Score at Week 10 Endpoint
Timepoint [6] 0 0
Baseline, 10 weeks
Secondary outcome [7] 0 0
Change From Baseline in Blood Pressure (BP) at Week 6 and Week 14 Endpoint
Timepoint [7] 0 0
Baseline, 6 weeks, 14 weeks
Secondary outcome [8] 0 0
Change From Baseline in Pulse Rate at Week 6 and Week 14 Endpoint
Timepoint [8] 0 0
Baseline, 6 weeks, 14 weeks
Secondary outcome [9] 0 0
Change From Baseline in Body Weight at Week 6 and Week 14 Endpoint
Timepoint [9] 0 0
Baseline, 6 weeks, 14 weeks
Secondary outcome [10] 0 0
Number of Participants With Suicidal Behaviors and Ideations
Timepoint [10] 0 0
Baseline through 14 weeks

Eligibility
Key inclusion criteria
* Outpatients between 6-16 years of age
* Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) diagnostic criteria for ADHD must be met
* Normal laboratory and electrocardiogram (ECG) results
* Normal intelligence
* Must have unsatisfactory symptom response to stimulant therapy or experience of adverse events while on stimulant therapy
Minimum age
6 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Less than 20 kg or more than 70 kg at study entry
* Concomitant major psychiatry disorders, drug or alcohol abuse or serious suicide risk
* Medical conditions such as seizures, severe allergies, glaucoma, cardiovascular disease, hypertension, or acute or unstable medical conditions
* Taking of anticonvulsants, antihypertensive agents, medication with sympathomimetic activity, psychotropic medications, monoamine oxidase inhibitor
* Immediate need for stimulant discontinuation due to tolerability problems
* Previous participation in an atomoxetine study, or unresponsive to atomoxetine, or intolerable side effects to atomoxetine

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
Open (masking not 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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2010
Sample size
Target
Accrual to date
Final
112
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Milton
Recruitment postcode(s) [1] 0 0
4064 - Milton
Recruitment outside Australia
Country [1] 0 0
Mexico
State/province [1] 0 0
Zona Centro
Country [2] 0 0
United Kingdom
State/province [2] 0 0
Scotland
Country [3] 0 0
United Kingdom
State/province [3] 0 0
South Yorkshire
Country [4] 0 0
United Kingdom
State/province [4] 0 0
West Midlands
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Northampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD) who are not tolerating or not responding well to stimulant therapy will be included in this study. Two different strategies for transition from Stimulant to Atomoxetine will be used: Slow (10 weeks) and fast (2 weeks). Changes in ADHD symptoms and tolerability of medication will be compared between the two different switching approaches.
Trial website
https://clinicaltrials.gov/study/NCT00760747
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) Mon-Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00760747