Attention Deficit Hyperactivity DisorderPhase 4NCT00517647
Atomoxetine Pilot Study in Preschool Children With ADHD
A Phase 4 study testing ATMX in people with Attention Deficit Hyperactivity Disorder, run by University of Arizona at 1 site in United States.
Trial summary
The purpose of this study is to determine if atomoxetine (a common brand name is Strattera), a medicine that is used for treating older children with Attention Deficit and Hyperactivity Disorder (ADHD), is also safe and helpful for ADHD problems in young children. Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- ATMX
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Mar 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 3 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child must be 36-69 months old at the time of screening to insure that the child can complete the short-term safety and efficacy trial before the age of 6 years.
- Child must have categorical and dimensional evidence of clinically significant ADHD symptoms in multiple settings that have been present for at least six months.
- ADHD symptoms must cause significant functional impairment in the child. Child must meet impairment scale threshold based on Children's Global Assessment Scale (C-GAS, Shaffer, Gould, Brasic et al., 1983) score < 60.
- Child must have resided with primary caretaker for at least 6 months prior to the screening.
- Child's heart rate must be within the 98th percentile and blood pressure within the 95th percentile by age and gender and oral temperature values within the normal range.
Who cannot join
- Child with prior failed treatment with an adequate trial of ATMX (defined by a minimum of 1.8 mg/kg/day for 4 weeks) or known hypersensitivity to ATMX. Prior failure on stimulants or other psychotropics will not be the sole reason for exclusion.
- Child is taking MAOI or there have been less than 2 weeks since it was discontinued.
- Concurrent treatment with other medications that have CNS effects or that affect performance (e.g., antidepressants, antipsychotics, alpha-agonists, adrenergic blockers, lithium carbonate, sedating antihistamines, decongestant or sympathomimetics). Child should be off of previous psychotropic medications for a minimum duration of one week for stimulants, clonidine or guanfacine; two weeks for bupropion, tricyclic antidepressants, venlafaxine, SSRIs (except fluoxetine and citalopram), valproate; and three weeks for fluoxetine, citalopram, and neuroleptics.
- Child has narrow angle glaucoma.
- Child who has a major medical condition that would interfere with involvement in the study or would be affected negatively by ATMX (i.e., heart disease, high blood pressure, glaucoma, untreated or unstable hyperthyroidism, uncontrolled seizure disorder, or illnesses that would require hospitalization).
- Child with co-morbid psychiatric diagnoses of Major Depression, Bipolar Disorder, a psychotic disorder, or other psychiatric disorders in addition to ADHD that requires concurrent treatment with additional/alternative medication.
- Current history of physical, sexual, or emotional abuse.
- The patient has taken an investigational drug within the last 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arizona Department of Psychiatry
Tucson, Arizona, 85724
About this study
The purpose of this study is to determine if atomoxetine (a common brand name is Strattera), a medicine that is used for treating older children with Attention Deficit and Hyperactivity Disorder (ADHD), is also safe and helpful for ADHD problems in young children. While atomoxetine is not approved by the FDA for use in children younger than 6 years, the FDA has given permission to study this drug in this age group.
Read the detailed description
Prevalence of Attention Deficit Hyperactivity Disorder ADHD in school age children is estimated to be 2% to 11%. Many preschool age children have problems with hyperactivity, short attention span, impulsivity and other behavior dyscontrol and are quite likely to continue to have difficulties in elementary school years. Many of these children are referred for diagnosis and management of their difficult behavior and are diagnosed with ADHD. Children with ADHD often display disruptive behaviors that interfere with their functioning at school, home and in the community due to symptoms of hyperactivity, impulsiveness and inattention.
Symptoms of ADHD may be underdiagnosed and undertreated in preschool children. Preschool children with ADHD often require vigilant monitoring and supervision to ensure their safety. Symptoms of impulsivity, hyperactivity and distractibility often limit the effectiveness of educational and behavioral interventions. Hence, it is important to treat the symptoms of ADHD in children at an early age. Early intervention in children with ADHD may have an impact in the course of illness by abating longer-term disability in vulnerable children.
Pharmacological agents are considered a standard treatment recommendation in children with ADHD. Recently, a non-stimulant pharmacological agent, atomoxetine (ATMX), has been reported to be effective and safe in school-age children with ADHD. Data are not available for the usefulness of ATMX in children younger than 6 years. However, parents of younger children with ADHD are frequently asking practicing physicians to prescribe ATMX for their child since they do not want their child taking stimulants.
There is a need to carry out treatment trials with ATMX in preschool children with ADHD in order to collect data on how effective the drug is, its safety, and the best doses to administer to children with ADHD. Therefore, this study will be a pilot project to obtain preliminary data that will then be used to help set up a larger study that will examine preschool children with ADHD.
All subjects will be screened for eligibility inclusion and exclusion criteria. Since other therapies including behavior therapy are routinely indicated, for ethical reasons subjects will continue to receive all concurrent therapies throughout the study period. All concurrent therapies will be stabilized for a minimum period of 2 weeks prior to the child's entry into the drug phase of the study. At each medication follow-up visit, a detailed history will be obtained and recorded for all concurrent treatments.
If a child enrolls in this study, his/her participation will last approximately 7 to 13 weeks with a minimum of 7 outpatient daytime visits. The visits will be weekly in the beginning and then every other week once the child is taking an optimum dose of atomoxetine. Visits will take 1-5 hours each and will take place at the Department of Psychiatry in the Arizona Health Sciences Center (Tucson). The study consists of 2 periods.
Screening assessment: The screening visit(s) is/are used to determine if a child is eligible for participation. The child's teacher/daycare provider (with the parent's permission) and the parent(s) will need to complete some forms describing the child's problems with overactivity, impulsivity and inattention. The screening assessments may be completed over 1-2 visits. Each visit will take about 3-5 hours to complete. The research staff will evaluate each child to see if s/he has ADHD. Parents will be interviewed about their child's behavior. The child's teacher will be given several rating forms to complete. Parents will be asked to complete some questions about their child's development. Both parents (if available) and will be interviewed about their family histories.
After it is determined that a child is eligible to participate, there will be a baseline visit. The child's previous ineffective medication will be discontinued. The ratings done at the first visit will be repeated, including both the teacher and parent rating scales. The child will have vital signs taken including height, weight, blood pressure and pulse rate, an electrocardiogram (EKG) (a test of heart rhythm recorded by putting sticky pads on the chest), a urine test and a blood test (about 10cc or 1 tablespoon). The doctor will ask the parents about the child's medical history. Parents will be told about any abnormal laboratory values or physical findings that may be discovered during this study. This information will also be available to the child's pediatrician if the parents request this be done.
Medication phase: After screening assessments are completed, the child will enter the medication phase of the study. The child will be started on atomoxetine at 0.5 mg/kg/day, with the dosage increased to a maximum dose of 1.8 mg/kg/day. The dose will be determined by how well the child responds to and tolerates the drug. The dose will be given twice a day to minimize side effects. After the optimum dose is determined, the child will be kept at this stable dose for 4 weeks.
At each visit, vital signs will be taken including height, weight, blood pressure, and pulse rate. Interviews, play assessments, checklist, and questionnaires will be completed at each visit in order to assess how well the child is doing, and whether there are symptoms or side effects. Teachers will also continue to be asked to fill out assessments.
If the child's behavior gets worse or s/he experiences any side effects, parents should call the study doctor immediately and it will be determined if any changes in the child's treatment will need to be made. Participants will be given a card with telephone numbers and important information needed to get in touch with the doctor at any time, day or night.
Some of the screening assessments will be videotaped/audiotaped. These tapes will be used for later coding, supervision of the child's doctor/therapist, review by offsite consultants/mentors, training of other doctors/therapists, and/or for presentations at conferences. The tapes can be erased at any time during or after the session at the parent's request.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- ATMX
- Keywords
- ADHD, atomoxetine, preschool children, efficacy, safety
- 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.
ATMXDrug
Medication phase: After screening assessments are completed, the child will enter the medication phase of the study. The child will be started on atomoxetine at 0.5 mg/kg/day, with the dosage increased to a maximum dose of 1.8 mg/kg/day. The dose will be determined by how well the child responds to and tolerates the drug. The dose will be given twice a day to minimize side effects. After the optimum dose is determined, the child will be kept at this stable dose for 4 weeks.
What is being measured
The primary outcome is the main question the study is designed to answer.
A reduction of 30% in the Hyperactive-Impulsive (HI) subscale scores of the Conners Rating Scale-Revised, which indicates an improvement in both efficacy and a significant clinical improvement in the child.
Measured: 7 to 13 weeks
Secondary outcomes (1)
Decrease in ADHD specific symptom severity and impairment
Measured: 7 to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2007 (estimated)
- Study startApr 2004
- Primary completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jaswinder K Ghuman, M.D., Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00517647
- Sponsor's protocol ID
- HSC04-22
- Status last verified
- Jul 2012
- First submitted
- 15 Aug 2007
- Last updated
- 9 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atomoxetine Pilot Study in Preschool Children With ADHD
- ClinicalTrials.gov ID
- NCT00517647
- Acronym / sponsor ID
- HSC04-22
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, atomoxetine, preschool children, efficacy, safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- Apr 2004
- Primary completion
- Mar 2008 (actual)
- First posted
- 17 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if atomoxetine (a common brand name is Strattera), a medicine that is used for treating older children with Attention Deficit and Hyperactivity Disorder (ADHD), is also safe and helpful for ADHD problems in young children. While atomoxetine is not approved by the FDA for use in children younger than 6 years, the FDA has given permission to study this drug in this age group.
Detailed description
Prevalence of Attention Deficit Hyperactivity Disorder ADHD in school age children is estimated to be 2% to 11%. Many preschool age children have problems with hyperactivity, short attention span, impulsivity and other behavior dyscontrol and are quite likely to continue to have difficulties in elementary school years. Many of these children are referred for diagnosis and management of their difficult behavior and are diagnosed with ADHD. Children with ADHD often display disruptive behaviors that interfere with their functioning at school, home and in the community due to symptoms of hyperactivity, impulsiveness and inattention.
Symptoms of ADHD may be underdiagnosed and undertreated in preschool children. Preschool children with ADHD often require vigilant monitoring and supervision to ensure their safety. Symptoms of impulsivity, hyperactivity and distractibility often limit the effectiveness of educational and behavioral interventions. Hence, it is important to treat the symptoms of ADHD in children at an early age. Early intervention in children with ADHD may have an impact in the course of illness by abating longer-term disability in vulnerable children.
Pharmacological agents are considered a standard treatment recommendation in children with ADHD. Recently, a non-stimulant pharmacological agent, atomoxetine (ATMX), has been reported to be effective and safe in school-age children with ADHD. Data are not available for the usefulness of ATMX in children younger than 6 years. However, parents of younger children with ADHD are frequently asking practicing physicians to prescribe ATMX for their child since they do not want their child taking stimulants.
There is a need to carry out treatment trials with ATMX in preschool children with ADHD in order to collect data on how effective the drug is, its safety, and the best doses to administer to children with ADHD. Therefore, this study will be a pilot project to obtain preliminary data that will then be used to help set up a larger study that will examine preschool children with ADHD.
All subjects will be screened for eligibility inclusion and exclusion criteria. Since other therapies including behavior therapy are routinely indicated, for ethical reasons subjects will continue to receive all concurrent therapies throughout the study period. All concurrent therapies will be stabilized for a minimum period of 2 weeks prior to the child's entry into the drug phase of the study. At each medication follow-up visit, a detailed history will be obtained and recorded for all concurrent treatments.
If a child enrolls in this study, his/her participation will last approximately 7 to 13 weeks with a minimum of 7 outpatient daytime visits. The visits will be weekly in the beginning and then every other week once the child is taking an optimum dose of atomoxetine. Visits will take 1-5 hours each and will take place at the Department of Psychiatry in the Arizona Health Sciences Center (Tucson). The study consists of 2 periods.
Screening assessment: The screening visit(s) is/are used to determine if a child is eligible for participation. The child's teacher/daycare provider (with the parent's permission) and the parent(s) will need to complete some forms describing the child's problems with overactivity, impulsivity and inattention. The screening assessments may be completed over 1-2 visits. Each visit will take about 3-5 hours to complete. The research staff will evaluate each child to see if s/he has ADHD. Parents will be interviewed about their child's behavior. The child's teacher will be given several rating forms to complete. Parents will be asked to complete some questions about their child's development. Both parents (if available) and will be interviewed about their family histories.
After it is determined that a child is eligible to participate, there will be a baseline visit. The child's previous ineffective medication will be discontinued. The ratings done at the first visit will be repeated, including both the teacher and parent rating scales. The child will have vital signs taken including height, weight, blood pressure and pulse rate, an electrocardiogram (EKG) (a test of heart rhythm recorded by putting sticky pads on the chest), a urine test and a blood test (about 10cc or 1 tablespoon). The doctor will ask the parents about the child's medical history. Parents will be told about any abnormal laboratory values or physical findings that may be discovered during this study. This information will also be available to the child's pediatrician if the parents request this be done.
Medication phase: After screening assessments are completed, the child will enter the medication phase of the study. The child will be started on atomoxetine at 0.5 mg/kg/day, with the dosage increased to a maximum dose of 1.8 mg/kg/day. The dose will be determined by how well the child responds to and tolerates the drug. The dose will be given twice a day to minimize side effects. After the optimum dose is determined, the child will be kept at this stable dose for 4 weeks.
At each visit, vital signs will be taken including height, weight, blood pressure, and pulse rate. Interviews, play assessments, checklist, and questionnaires will be completed at each visit in order to assess how well the child is doing, and whether there are symptoms or side effects. Teachers will also continue to be asked to fill out assessments.
If the child's behavior gets worse or s/he experiences any side effects, parents should call the study doctor immediately and it will be determined if any changes in the child's treatment will need to be made. Participants will be given a card with telephone numbers and important information needed to get in touch with the doctor at any time, day or night.
Some of the screening assessments will be videotaped/audiotaped. These tapes will be used for later coding, supervision of the child's doctor/therapist, review by offsite consultants/mentors, training of other doctors/therapists, and/or for presentations at conferences. The tapes can be erased at any time during or after the session at the parent's request.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Child must be 36-69 months old at the time of screening to insure that the child can complete the short-term safety and efficacy trial before the age of 6 years.
- Child must have categorical and dimensional evidence of clinically significant ADHD symptoms in multiple settings that have been present for at least six months.
- ADHD symptoms must cause significant functional impairment in the child. Child must meet impairment scale threshold based on Children's Global Assessment Scale (C-GAS, Shaffer, Gould, Brasic et al., 1983) score < 60.
- Child must have resided with primary caretaker for at least 6 months prior to the screening.
- Child's heart rate must be within the 98th percentile and blood pressure within the 95th percentile by age and gender and oral temperature values within the normal range.
Key exclusion criteria (8 listed)
- Child with prior failed treatment with an adequate trial of ATMX (defined by a minimum of 1.8 mg/kg/day for 4 weeks) or known hypersensitivity to ATMX. Prior failure on stimulants or other psychotropics will not be the sole reason for exclusion.
- Child is taking MAOI or there have been less than 2 weeks since it was discontinued.
- Concurrent treatment with other medications that have CNS effects or that affect performance (e.g., antidepressants, antipsychotics, alpha-agonists, adrenergic blockers, lithium carbonate, sedating antihistamines, decongestant or sympathomimetics). Child should be off of previous psychotropic medications for a minimum duration of one week for stimulants, clonidine or guanfacine; two weeks for bupropion, tricyclic antidepressants, venlafaxine, SSRIs (except fluoxetine and citalopram), valproate; and three weeks for fluoxetine, citalopram, and neuroleptics.
- Child has narrow angle glaucoma.
- Child who has a major medical condition that would interfere with involvement in the study or would be affected negatively by ATMX (i.e., heart disease, high blood pressure, glaucoma, untreated or unstable hyperthyroidism, uncontrolled seizure disorder, or illnesses that would require hospitalization).
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 |
|---|---|---|
| ATMXMedication phase: After screening assessments are completed, the child will enter the medication phase of the study. The child will be started on atomoxetine at 0.5 mg/kg/day, with the dosage increased to a maximum dose of 1.8 mg/kg/day. The dose will be determined by how well the child responds to and tolerates the drug. The dose will be given twice a day to minimize side effects. After the optimum dose is determined, the child will be kept at this stable dose for 4 weeks. | Drug | – |
Primary outcome
A reduction of 30% in the Hyperactive-Impulsive (HI) subscale scores of the Conners Rating Scale-Revised, which indicates an improvement in both efficacy and a significant clinical improvement in the child.
Time frame: 7 to 13 weeks
1 secondary outcome
Decrease in ADHD specific symptom severity and impairment
Time frame: 7 to 13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2012.
Related trials for Attention Deficit Hyperactivity Disorder
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
RecruitingPhase 2
A Study to Evaluate Safety and Efficacy of ALKS 7290 Compared With Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder (ALKS 7290-201)
Attention Deficit Disorder With Hyperactivity (ADHD)
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
RecruitingObservational study
Pharmacogenomics of Stimulant Treatment Response
Attention-Deficit/ Hyperactivity Disorder (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.
Jaswinder K Ghuman, M.D. principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ATMX in people with Attention Deficit Hyperactivity Disorder, run by University of Arizona at 1 site 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 5 inclusion and 8 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 9 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
A reduction of 30% in the Hyperactive-Impulsive (HI) subscale scores of the Conners Rating Scale-Revised, which indicates an improvement in both efficacy and a significant clinical improvement in the child. (time frame: 7 to 13 weeks). 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 9 Jul 2012.