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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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)
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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)
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Secondary ID [1]
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B4Z-EW-LYFJ
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Secondary ID [2]
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12305
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Universal Trial Number (UTN)
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Trial acronym
ADHD SWITCH
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Attention Deficit Hyperactivity Disorder
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Condition category
Condition code
Neurological
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Other neurological disorders
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Mental Health
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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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)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Higher score indicates greater severity of disease. Least squares means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.
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Timepoint [1]
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Baseline, 10 weeks
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Primary outcome [2]
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Change From Baseline in ADHD-RS-IV Parent Version: Investigator Administered and Scored - Total Score at Week 2 Endpoint
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Assessment method [2]
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Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Higher score indicates greater severity of disease. Least squares means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.
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Timepoint [2]
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Baseline, 2 weeks
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Secondary outcome [1]
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Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale - Patient Total Score at Week 10 Endpoint
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Assessment method [1]
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The GIPD scale is a 5-item rating of ADHD-related difficulties (overall difficulties perceived in the morning, during school, during homework, in the evening, and over the entire day and night). For each item, difficulties during the past week are rated on a 7-point scale (1 = normal, not difficult at all; 7 = extremely difficult) and the mean of the 5 items is reported. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.
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Timepoint [1]
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Baseline, 10 weeks
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Secondary outcome [2]
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Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Parent Total Score at Week 10 Endpoint
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Assessment method [2]
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The GIPD scale is a 5-item rating of ADHD-related difficulties (overall difficulties perceived in the morning, during school, during homework, in the evening, and over the entire day and night). For each item, difficulties during the past week are rated on a 7-point scale (1 = normal, not difficult at all; 7 = extremely difficult) and the mean of the 5 items is reported. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.
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Timepoint [2]
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Baseline, 10 weeks
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Secondary outcome [3]
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Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Investigator Total Score at Week 10 Endpoint
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Assessment method [3]
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The GIPD scale is a 5-item rating of ADHD-related difficulties (overall difficulties perceived in the morning, during school, during homework, in the evening, and over the entire day and night). For each item, difficulties during the past week are rated on a 7-point scale (1 = normal, not difficult at all; 7 = extremely difficult) and the mean of the 5 items is reported. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.
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Timepoint [3]
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Baseline, 10 weeks
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Secondary outcome [4]
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Change From Baseline in Clinical Global Impression Severity (CGI-S) Rating Scale - Total Score at Week 10 Endpoint
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Assessment method [4]
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The CGI- S is a single-item clinician rating of the severity of the participant's ADHD symptoms in relation to the clinician's total experience of ADHD participants. Severity is rated on a seven-point scale (1 = normal, not ill at all; 7 = among the most extremely ill patients). Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.
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Timepoint [4]
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Baseline, 10 weeks
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Secondary outcome [5]
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Change From Baseline in Child Health and Illness Profile Child Edition-Parent Report Form (CHIP-CE-PRF) - Domain Scores at Week 10 Endpoint
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Assessment method [5]
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CHIP-CE-PRF consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format. Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation (SD) of 10. Standard scores are expressed in SD units. T-score=[(Score- Mean for the reference population [Ref Pop])*10/SD for the Ref Pop]+50. Higher scores mean better quality of life. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.
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Timepoint [5]
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Baseline, 10 weeks
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Secondary outcome [6]
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Change From Baseline in Treatment Satisfaction Preference Survey Mean Score at Week 10 Endpoint
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Assessment method [6]
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The Treatment Satisfaction Survey consists of a five-question survey each rated on a 5 point scale (0=very satisfied/very likely, 4=very dissatisfied/not at all likely). The mean score over the items is reported.
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Timepoint [6]
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Baseline, 10 weeks
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Secondary outcome [7]
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Change From Baseline in Blood Pressure (BP) at Week 6 and Week 14 Endpoint
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Assessment method [7]
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Timepoint [7]
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Baseline, 6 weeks, 14 weeks
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Secondary outcome [8]
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Change From Baseline in Pulse Rate at Week 6 and Week 14 Endpoint
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Assessment method [8]
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Timepoint [8]
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Baseline, 6 weeks, 14 weeks
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Secondary outcome [9]
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Change From Baseline in Body Weight at Week 6 and Week 14 Endpoint
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Assessment method [9]
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Timepoint [9]
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Baseline, 6 weeks, 14 weeks
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Secondary outcome [10]
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Number of Participants With Suicidal Behaviors and Ideations
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Assessment method [10]
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Columbia Suicide Rating Scale (C-SSRS): scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors and ideations are provided. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation.
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Timepoint [10]
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Baseline through 14 weeks
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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
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Minimum age
6
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Maximum age
16
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2010
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Sample size
Target
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Accrual to date
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Final
112
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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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
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Recruitment postcode(s) [1]
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4064 - Milton
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Recruitment outside Australia
Country [1]
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Mexico
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State/province [1]
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Zona Centro
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Country [2]
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United Kingdom
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State/province [2]
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Scotland
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Country [3]
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United Kingdom
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State/province [3]
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South Yorkshire
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Country [4]
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United Kingdom
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State/province [4]
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West Midlands
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Country [5]
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United Kingdom
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State/province [5]
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Northampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eli Lilly and Company
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00760747
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Call 1-877-CTLILLY (1-877-285-4559) Mon-Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
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Address
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Eli Lilly and Company
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00760747
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