Attention Deficit Disorder With HyperactivityPhase 4NCT00254462
Atomoxetine for Treating Attention Deficit Hyperactivity Disorder in Young Children
A Phase 4 study testing Atomoxetine and Parent Training in people with Attention Deficit Disorder With Hyperactivity, run by University of Nebraska at 3 sites in United States.
Trial summary
This study will evaluate the effectiveness of atomoxetine in reducing the symptoms of attention deficit hyperactivity disorder (ADHD) in young children. Read more about this study
- Who is it for?
- Ages 5 to 6 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Atomoxetine and Parent Training
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Oct 2005to 1 Sep 2008
- 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 5 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parent and child must be English speaking
- Child has been living with parent/guardian for at least six months
- Meets criteria for ADHD on the DISC, on clinical interview, and on clinical consensus conference
- ADHD is primary disorder with symptoms present for at least 9 months
- ADHD-IV-Rating Scale (ADHD-IV-RS)score that is at least 1.5 standard deviations above age and sex norms
- Score of 55 or below on the Children's Global Assessment Scale
Show all 11Show fewer
- Score of 4 or greater on the Clinical Global Impression Scale
- Estimated Intelligence Quotient (IQ) of 70 or greater
- Currently participating in school at least 2 half-days per week
- Able to identify a teacher who can make valid assessments
- Patient and parent are able to attend regular study visits
Who cannot join
- Currently taking other psychotropic medications or other medications with effects on the central nervous system
- Currently being treated effectively with atomoxetine
- Major medical conditions that might interfere with study medications
- History of or current clinically significant kidney illness
- Evidence of adjustment disorder, autism, psychosis, bipolar disorder, suicide ideations, or any other psychiatric disorder requiring treatment with additional psychotropic medication
- History of physical, sexual, or emotional abuse impacting clinical presentation
- Prior failure to respond to an adequate trial of atomoxetine
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Duke University Medical Center
Durham, North Carolina, 27705
New York State Psychiatric Institute
New York, New York, 10032
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: Pharmacological Treatment of ADHD in Young Children
This study will evaluate the effectiveness of atomoxetine in reducing the symptoms of attention deficit hyperactivity disorder (ADHD) in young children.
Read the detailed description
Attention deficit hyperactivity disorder (ADHD) is one of the most common mental disorders in children. Children with ADHD often have impaired functioning in home and school and usually experience difficulty relating to peers. If left untreated, the disorder can have long-term adverse effects into adolescence and adulthood. Atomoxetine is a selective noradrenergic reuptake inhibitor that is FDA-approved for the treatment of ADHD in children, adolescents, and adults. Unlike most other medications for ADHD, atomoxetine is not a stimulant. Studies have shown that atomoxetine is effective in treating ADHD, but more information is needed on its effectiveness in young children. This study will evaluate the effectiveness of atomoxetine in reducing the symptoms of ADHD in young children.
Participants in this double-blind study will be randomly assigned to receive either atomoxetine or placebo for 8 weeks. In addition, all children will receive parent training for the duration of the study. For the first 5 weeks, participants will report to the study site weekly for assessments of ADHD symptoms. Study visits will occur every other week for the remainder of the study.
- Being tested
- Atomoxetine, Placebo, Parent Training
- Keywords
- ADHD, Atomoxetine
- 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 Strattera
Participants will receive atomoxetine for 8 weeks up to a maximum of 1.8 mg/kg/day. Dosed once daily in capsule formulation.
PlaceboDrug
Also called Pill placebo
Participants will receive placebo for 8 weeks. Dosed once daily, capsule formulation.
Parent TrainingBehavioural
Also called Psychosocial and educational intervention
All children will receive parent training for the duration of the study.
| Study group | Role | What they receive |
|---|---|---|
| atomoxetine and parent training | Experimental | atomoxetine capsules, dose 0.5mg/kg/day to 1.8mg/kg/day administered once daily for 8 weeks Receives: Drug: Atomoxetine; Behavioral: Parent Training |
| placebo and parent training | Placebo comparator | matching placebo capsules, dose 0.5mg/kg/day to 1.8mg/kg/day administered once daily for 8 weeks Receives: Drug: Placebo; Behavioral: Parent Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ADHD-IV Rating Scale Total Score
Measures 18 symptoms of attention deficit hyperactivity disorder (ADHD). Each symptom rated 0-3, for a minimum total score of 0, and a maximum total score of 54 for the scale. A higher score reflects more severe symptomatology.
The inattentive subscale and the hyperactive/impulsive subscale each has a minimum score of 0 and maximum score of 27.
Measured: Measured at baseline and at Week 8. These are the only two timepoints calculated, later timepoint subtracted from earlier timepoint.
Secondary outcomes (1)
Change in Total ADHD-IV Teacher
Measures 18 symptoms of ADHD. Each symptom rated 0-3, for a maximum total score of 54 for the scale. A higher score reflects more severe symptomatology.
Measured: Measured at baseline and at Week 8. Later time point is subtracted from earlier time point.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2005 (estimated)
- Study start1 Oct 2005
- Primary completion1 Aug 2008
- Study completion1 Sep 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Christopher J Kratochvil, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00254462
- Sponsor's protocol ID
- 0164-03-FB
- Other IDs
- K23MH066127
- Status last verified
- Sep 2023
- First submitted
- 14 Nov 2005
- Last updated
- 2 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Kratochvil CJ, Vaughan BS, Stoner JA, Daughton JM, Lubberstedt BD, Murray DW, Chrisman AK, Faircloth MA, Itchon-Ramos NB, Kollins SH, Maayan LA, Greenhill LL, Kotler LA, Fried J, March JS. A double-blind, placebo-controlled study of atomoxetine in young children with ADHD. Pediatrics. 2011 Apr;127(4):e862-8. doi: 10.1542/peds.2010-0825. Epub 2011 Mar 21.
PubMed 21422081
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological Treatment of ADHD in Young Children
- ClinicalTrials.gov ID
- NCT00254462
- Acronym / sponsor ID
- 0164-03-FB
- Keywords
- ADHD, Atomoxetine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Oct 2005 (actual)
- Primary completion
- 1 Aug 2008 (actual)
- Study completion
- 1 Sep 2008 (actual)
- First posted
- 16 Nov 2005 (estimated)
- Results
- Posted 17 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effectiveness of atomoxetine in reducing the symptoms of attention deficit hyperactivity disorder (ADHD) in young children.
Detailed description
Attention deficit hyperactivity disorder (ADHD) is one of the most common mental disorders in children. Children with ADHD often have impaired functioning in home and school and usually experience difficulty relating to peers. If left untreated, the disorder can have long-term adverse effects into adolescence and adulthood. Atomoxetine is a selective noradrenergic reuptake inhibitor that is FDA-approved for the treatment of ADHD in children, adolescents, and adults. Unlike most other medications for ADHD, atomoxetine is not a stimulant. Studies have shown that atomoxetine is effective in treating ADHD, but more information is needed on its effectiveness in young children. This study will evaluate the effectiveness of atomoxetine in reducing the symptoms of ADHD in young children.
Participants in this double-blind study will be randomly assigned to receive either atomoxetine or placebo for 8 weeks. In addition, all children will receive parent training for the duration of the study. For the first 5 weeks, participants will report to the study site weekly for assessments of ADHD symptoms. Study visits will occur every other week for the remainder of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| atomoxetine and parent training | Experimental | Drug: Atomoxetine, Behavioral: Parent Trainingatomoxetine capsules, dose 0.5mg/kg/day to 1.8mg/kg/day administered once daily for 8 weeks |
| placebo and parent training | Placebo comparator | Drug: Placebo, Behavioral: Parent Trainingmatching placebo capsules, dose 0.5mg/kg/day to 1.8mg/kg/day administered once daily for 8 weeks |
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Parent and child must be English speaking
- Child has been living with parent/guardian for at least six months
- Meets criteria for ADHD on the DISC, on clinical interview, and on clinical consensus conference
- ADHD is primary disorder with symptoms present for at least 9 months
- ADHD-IV-Rating Scale (ADHD-IV-RS)score that is at least 1.5 standard deviations above age and sex norms
Key exclusion criteria (7 listed)
- Currently taking other psychotropic medications or other medications with effects on the central nervous system
- Currently being treated effectively with atomoxetine
- Major medical conditions that might interfere with study medications
- History of or current clinically significant kidney illness
- Evidence of adjustment disorder, autism, psychosis, bipolar disorder, suicide ideations, or any other psychiatric disorder requiring treatment with additional psychotropic medication
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: StratteraParticipants will receive atomoxetine for 8 weeks up to a maximum of 1.8 mg/kg/day. Dosed once daily in capsule formulation. | Drug | atomoxetine and parent training |
| PlaceboAlso: Pill placeboParticipants will receive placebo for 8 weeks. Dosed once daily, capsule formulation. | Drug | placebo and parent training |
| Parent TrainingAlso: Psychosocial and educational interventionAll children will receive parent training for the duration of the study. | Behavioural | atomoxetine and parent training, placebo and parent training |
Primary outcome
Change in ADHD-IV Rating Scale Total Score
Time frame: Measured at baseline and at Week 8. These are the only two timepoints calculated, later timepoint subtracted from earlier timepoint.
Measures 18 symptoms of attention deficit hyperactivity disorder (ADHD). Each symptom rated 0-3, for a minimum total score of 0, and a maximum total score of 54 for the scale. A higher score reflects more severe symptomatology. The inattentive subscale and the hyperactive/impulsive subscale each has a minimum score of 0 and maximum score of 27.
1 secondary outcome
Change in Total ADHD-IV Teacher
Time frame: Measured at baseline and at Week 8. Later time point is subtracted from earlier time point.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21422081Kratochvil CJ, Vaughan BS, Stoner JA, Daughton JM, Lubberstedt BD, Murray DW, Chrisman AK, Faircloth MA, Itchon-Ramos NB, Kollins SH, Maayan LA, Greenhill LL, Kotler LA, Fried J, March JS. A double-blind, placebo-controlled study of atomoxetine in young children with ADHD. Pediatrics. 2011 Apr;127(4):e862-8. doi: 10.1542/peds.2010-0825. Epub 2011 Mar 21.
Related trials for Attention Deficit Disorder With Hyperactivity
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
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
RecruitingPhase 3
A Study to Test the Effects of Centanafadine in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation
Attention-deficit/Hyperactivity Disorder, Emotional Dysregulation
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.
Christopher J Kratochvil, MD principal investigator
University of Nebraska
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atomoxetine and Parent Training in people with Attention Deficit Disorder With Hyperactivity, run by University of Nebraska at 3 sites in United States.
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 11 inclusion and 7 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 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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. Some participants in this study may receive a placebo. 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 17 Jul 2013). 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 in ADHD-IV Rating Scale Total Score (time frame: Measured at baseline and at Week 8. These are the only two timepoints calculated, later timepoint subtracted from earlier timepoint.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00254462, which also lists 1 linked publication.
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 2 Oct 2023.