Attention Deficit Hyperactivity DisorderPhase 4ADHD SWITCHNCT00760747
Comparison of Slow and Fast Transition From Stimulants to Atomoxetine in Children and Adolescents With Attention Deficit/Hyperactivity Disorder(ADHD)
A Phase 4 study testing Atomoxetine in people with Attention Deficit Hyperactivity Disorder, run by Eli Lilly and Company at 6 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Atomoxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Sep 2008to Sep 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United Kingdom4 sites
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.
Birmingham, West Midlands, B13 8QE
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.
Fife, Scotland, KY2 5AH
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.
Northampton, NN1 2BG
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.
Sheffield, South Yorkshire, S10 5DD
Australia1 site
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, Queensland, 4064
Mexico1 site
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.
Zona Centro, 37000
About this study
Official 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)
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.
Read the detailed description
Study B4Z-EW-LYFJ is a phase IV multicentre, open label, controlled study in approximately 120 patients with ADHD from 6 years to 16 years of age. After the screening period, patients will be randomized (centrally in a 1:1 ratio) either to a transition period of 10 weeks (slow switching arm) or to a transition period of 2 weeks (fast switching arm). After completion of the 10 week open phase patients will be treated for a further 4 weeks with atomoxetine.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Atomoxetine
- Keywords
- ADHD, Children, Stimulant, Atomoxetine, Adolescents
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtomoxetineDrug
Also called LY139603, Strattera
1.2 mg/kg/day up to 1.8 mg/kg/day, orally (PO)
| Study group | Role | What they receive |
|---|---|---|
| Slow Switching Group | Experimental | 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 Receives: Drug: Atomoxetine |
| Fast Switching Group | Experimental | 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 Receives: Drug: Atomoxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: Baseline, 10 weeks
Change From Baseline in ADHD-RS-IV Parent Version: Investigator Administered and Scored - Total Score at Week 2 Endpoint
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.
Measured: Baseline, 2 weeks
Secondary outcomes (10)
Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale - Patient Total Score at Week 10 Endpoint
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.
Measured: Baseline, 10 weeks
Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Parent Total Score at Week 10 Endpoint
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.
Measured: Baseline, 10 weeks
Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Investigator Total Score at Week 10 Endpoint
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.
Measured: Baseline, 10 weeks
Change From Baseline in Clinical Global Impression Severity (CGI-S) Rating Scale - Total Score at Week 10 Endpoint
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.
Measured: Baseline, 10 weeks
Change From Baseline in Child Health and Illness Profile Child Edition-Parent Report Form (CHIP-CE-PRF) - Domain Scores at Week 10 Endpoint
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.
Measured: Baseline, 10 weeks
Change From Baseline in Treatment Satisfaction Preference Survey Mean Score at Week 10 Endpoint
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.
Measured: Baseline, 10 weeks
Change From Baseline in Blood Pressure (BP) at Week 6 and Week 14 Endpoint
Measured: Baseline, 6 weeks, 14 weeks
Change From Baseline in Pulse Rate at Week 6 and Week 14 Endpoint
Measured: Baseline, 6 weeks, 14 weeks
Change From Baseline in Body Weight at Week 6 and Week 14 Endpoint
Measured: Baseline, 6 weeks, 14 weeks
Number of Participants With Suicidal Behaviors and Ideations
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.
Measured: Baseline through 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionAug 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) Mon-Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760747
- Sponsor's protocol ID
- 12305
- Other IDs
- B4Z-EW-LYFJ
- Acronym
- ADHD SWITCH
- Status last verified
- Aug 2011
- First submitted
- 25 Sep 2008
- Last updated
- 1 Sep 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT00760747
- Acronym / sponsor ID
- ADHD SWITCH / 12305
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, Children, Stimulant, Atomoxetine, Adolescents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 26 Sep 2008 (estimated)
- Results
- Posted 1 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study B4Z-EW-LYFJ is a phase IV multicentre, open label, controlled study in approximately 120 patients with ADHD from 6 years to 16 years of age. After the screening period, patients will be randomized (centrally in a 1:1 ratio) either to a transition period of 10 weeks (slow switching arm) or to a transition period of 2 weeks (fast switching arm). After completion of the 10 week open phase patients will be treated for a further 4 weeks with atomoxetine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Slow Switching Group | Experimental | Drug: AtomoxetineSlow 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 |
| Fast Switching Group | Experimental | Drug: AtomoxetineFast 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 |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtomoxetineAlso: LY139603, Strattera1.2 mg/kg/day up to 1.8 mg/kg/day, orally (PO) | Drug | Fast Switching Group, Slow Switching Group |
Primary outcome
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
Time frame: Baseline, 10 weeks
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.
Change From Baseline in ADHD-RS-IV Parent Version: Investigator Administered and Scored - Total Score at Week 2 Endpoint
Time frame: Baseline, 2 weeks
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.
10 secondary outcomes
Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale - Patient Total Score at Week 10 Endpoint
Time frame: Baseline, 10 weeks
Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Parent Total Score at Week 10 Endpoint
Time frame: Baseline, 10 weeks
Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Investigator Total Score at Week 10 Endpoint
Time frame: Baseline, 10 weeks
Change From Baseline in Clinical Global Impression Severity (CGI-S) Rating Scale - Total Score at Week 10 Endpoint
Time frame: Baseline, 10 weeks
Change From Baseline in Child Health and Illness Profile Child Edition-Parent Report Form (CHIP-CE-PRF) - Domain Scores at Week 10 Endpoint
Time frame: Baseline, 10 weeks
Change From Baseline in Treatment Satisfaction Preference Survey Mean Score at Week 10 Endpoint
Time frame: Baseline, 10 weeks
Change From Baseline in Blood Pressure (BP) at Week 6 and Week 14 Endpoint
Time frame: Baseline, 6 weeks, 14 weeks
Change From Baseline in Pulse Rate at Week 6 and Week 14 Endpoint
Time frame: Baseline, 6 weeks, 14 weeks
Change From Baseline in Body Weight at Week 6 and Week 14 Endpoint
Time frame: Baseline, 6 weeks, 14 weeks
Number of Participants With Suicidal Behaviors and Ideations
Time frame: Baseline through 14 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Attention Deficit Hyperactivity Disorder
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) Mon-Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atomoxetine in people with Attention Deficit Hyperactivity Disorder, run by Eli Lilly and Company at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom, Australia, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline, 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2011.