ADHDPhase 3NCT01109849
Novel Approach to Stimulant Induced Weight Suppression and Its Impact on Growth
A Phase 3 study testing behavior therapy, Extended release (ER) methylphenidate product and monitoring in people with ADHD and Growth, run by Florida International University at 1 site in United States.
Trial summary
Previous NIH funded Attention Deficit Hyperactivity Disorder (ADHD) trials in children found that daily stimulant therapy produced sustained growth deficits. However, no federally funded studies have examined the growth suppression associated with modern once a day stimulant medications. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- What is being tested?
- behavior therapy, Extended release (ER) methylphenidate product and monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Apr 2016
- Phase
- Phase 3
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children meeting criteria for any subtype of ADHD between the ages of 5-12 who are stimulant naive
Who cannot join
- Children who meet any of the following criteria will not be eligible to participate in this study:
- children with a Full Scale Intelligence Quotient (I below 70 as children with IQs less than this would likely not benefit from the behavior therapy intervention
- not in full time school or less than 5 or older than 12 years at the time of the screening visit
- children who have a history of seizures or other neurological problems and are taking medication to prevent seizures as stimulants could worsen seizures
- children with a history of other medical problems for whom psychostimulant treatment may involve considerable risk including cardiac arrhythmias, hypertension, Tourette's Disorder or history of severe tic exacerbations secondary to stimulant exposure
- children with a history of other medical problems that could impact appetite or weight such as hypothyroidism, diabetes mellitus, liver or renal disease. Also, children using prescription medication that can significantly impact appetite or weight are excluded
Show all 10Show fewer
- children with a childhood history or diagnosis of any of the following mental health disorders: pervasive developmental disorder, schizophrenia or other psychotic disorders, bipolar disorder, post traumatic stress disorder, major depression with serious suicidal thoughts or an eating disorder as stimulants are not safe and effective treatments for these conditions, and these diseases could affect eating habits
- children whose Body Mass Index is very low (too light for safe use of stimulant medication) or is too high (overweight so not suitable for weight promotion treatments)
- children allergic to milk proteins as they are in the caloric supplement (lactose intolerance okay)
- children previously treated with stimulant medications for more than 30 days as this study is focusing on children who have never used stimulant medication before.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Children and Families, Florida International University
Miami, Florida, 33199
About this study
Previous NIH funded Attention Deficit Hyperactivity Disorder (ADHD) trials in children found that daily stimulant therapy produced sustained growth deficits. However, no federally funded studies have examined the growth suppression associated with modern once a day stimulant medications. Therefore, this study will precisely estimate the risks of stimulant induced growth suppression (SIGS), examine the underlying mechanisms and develop treatments for it. While drug holidays and caloric supplementation are two common treatments for SIGS, there has been little systematic investigation of either. It is unknown if they are effective or feasible. Therefore, using a randomized adaptive design, we will evaluate the efficacy and feasibility of these two practices vs. routine monitoring of growth in 180 prepubertal children with ADHD. An additional 50 subjects will be treated solely with behavioral therapies to evaluate for growth abnormalities associated with ADHD. The study will assess will the risk of SIGS with ER stimulants and the underlying mechanisms while providing evidenced-based treatments for its management.
Read the detailed description
The study will consist of 4 parts:
- Screening assessment to determine if a child has ADHD and would be a good candidate to have their ADHD treated with an extended release (ER) stimulant medication. If the answer to step one is yes, then the child will be randomly assigned to receive either medication treatment with an extended release MPH product (OROS MPH). 78% of children with start with this option with 22% assigned to behavioral therapy/counseling treatments for ADHD. There will be no placebo treatments used in this study. All children must be between the ages of 5 and 12 and never have taken stimulant medications for ADHD for more than one week to be eligible for the study.
- Initial Treatment Phase: The dose of the assigned treatment option will be gradually adjusted over the course of the first 3 months until the child's ADHD is well controlled. If the child is assigned to medication, he/she will start with a low dose of the ER MPH product, and it will be gradually increased until his/her ADHD is in good control. Children assigned to medication will be asked to take it every day of the week for at least the first 6 months. Children assigned to behavior therapy will be asked to avoid using medication for the first 6 months of the study. After month 6 if the first treatment is not effective, the child will be given the chance to try the other option. If any treatment is causing a concerning side effect, he/she can stop taking it at any time and we will provide him/her with other treatment options as part of the study.
- Ongoing Treatment Phase: We will continue to provide these ADHD treatments for a total of 30 months (2 1/2 years). The dose or type of therapy may be adjusted if needed. The child will be monitored every 1-3 months over this time span. Monitoring includes doctor visits to assess growth and side effects of medication, regular contact with his/her teacher to assess function at school and with you to assess function at home. In total, the child will receive study treatments for approximately 30 months and will be required to come to our center for a minimum of 18 follow up visits over this time. The average visit should take 30 minutes or less.
- Weight Recovery Phase: Any child whose body mass index or BMI declines by a concerning amount will be randomly assigned to receive 1 of 3 weight promotion treatments to stabilize his/her BMI in order to see if this prevents suppression of height (keeps them growing to be as tall as they should be). We do not expect children assigned to the behavior therapy arm to need these treatments, but the identical weight promotion treatments will be available for children in this group if the need arises.
- Extra monitoring: A doctor will check the child's growth every month (instead of every 3 months) until his/her BMI has returned to normal.The child will stay on the current daily dose of medication or behavior therapy.
- Caloric supplementation: Parents will be provided with a flavored calorie drink to give to your child every night and continue on the same daily dose and frequency of medication or behavior therapy. The child will have their growth monitored monthly by a study doctor.
- Drug Holiday: Participants will now only take medication on school days. Children assigned to behavior therapy will not participate in this treatment as they are not taking any study medication. The child will have their growth monitored monthly by a study doctor.
Once the child's weight recovers, these extra treatments will end and he/she will return to the prior medication treatment (medication7 days a week or behavior therapy) in step 3 and to every 3 month growth assessments. Any time the child's BMI declines again, the extra treatments will restart again.
- Being tested
- behavior therapy, Extended release (ER) methylphenidate product, monitoring, drug holiday, caloric supplement
- Keywords
- ADHD, growth, BMI, stimulant medication
- 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.
behavior therapyBehavioural
Also called behavior modification
combination of individual and group parent training plus school consultation
Extended release (ER) methylphenidate productDrug
Also called Concerta, OROS-MPH, Central Nervous Systemt (CNS) stimulants
medication to be taken daily for duration of study unless assigned to weight promotion arm
monitoringOther
Also called monitoring arm
monthly weight, height and BMI checks
drug holidayOther
Also called Ritalin based product, CNS stimulants
switch from seven day a week dosing to medication only on school days
caloric supplementDietary supplement
continue current ADHD regimen and add one 8oz liquid caloric supplement at night
| Study group | Role | What they receive |
|---|---|---|
| weight recovery treatment- monitoring | Active comparator | Subjects in either the behavior therapy arm or the medication arm will be assigned to one of 3 treatments if subject does not meet projected BMI goals. In the monitoring arm , participants will continue on their ER stimulant 7 days a week and have their weight, height and BMI checked monthly. Receives: Other: monitoring |
| behavior therapy | Active comparator | 10 week basic parent training, advanced 8 week parent training course. monthly boosters, option for individual parent training sessions, school consultant assigned to each subject Receives: Behavioral: behavior therapy |
| ER stimulant | Experimental | daily use of 12 hour extended release methylphenidate product Receives: Drug: Extended release (ER) methylphenidate product |
| weight recovery treatment- caloric supplement | Experimental | Subjects in either the behavior therapy arm or the medication arm will be assigned to one of 3 treatments if subject does not meet projected BMI goals. In the caloric supplement arm, participants will continue on their ER stimulant 7 days a week, have their weight, height and BMI checked monthly and be prescribed a 150 kcal caloric supplement to be consumed every evening. Receives: Dietary Supplement: caloric supplement |
| weight recovery treatment- drug holiday | Experimental | Subjects in either the behavior therapy arm or the medication arm will be assigned to one of 3 treatments if subject does not meet projected BMI goals. In the drug holiday arm, participants will only take their ER stimulant on school days a week and have their weight, height and BMI checked monthly. Receives: Other: drug holiday |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Score for Z-height Baseline to Endpoint
The primary endpoint will be change in z-height at month 30 which is study endpoint.
Measured as a zscore with more negative units reflecting smaller incremental height gain. Z units used to account for differences between groups in gender and age with both impact height at a fixed time.
Measured: month 30 or last assessment point
Secondary outcomes (11)
Change Score for z Weight
difference between baseline and endpoint (month 30 or last assessment point if did not finish study). Measured as a zscore with more negative units reflecting lesser weight gain. Z units used to account for differences between groups in gender and age with both impact weight at a fixed time.
Measured: baseline to month 30 or to last assessment point
Change in zBody Mass Index (BMI)
BMI will be calculated at endpoint (month 30). Difference between baseline and endpoint (month 30 or last assessment point if did not finish study). Measured as a zscore with more negative units reflecting less BMI gain. Z units used to account for differences between groups in gender and age with both impact BMI at a fixed time.
Measured: baseline to month 30 or last assessment point
Treatment Adherence for Caloric Supplement
percent of days caloric supplement were taken versus prescribed in caloric supplement arm
Measured: from entry to exit of caloric supplement arm
ADHD Symptoms- Parent Rated
sum of score on 10 item IOWA Conners with range from 0 to 30 and higher values indicating more symptoms. Collected at end point or last assessment point.
Measured: at month 30 or last collected assessment point
Change Score for Zheight Months 0 to 6
in addition to the primary outcome of height at month 30, change in z-height from baseline to study month 6 post is also reported. Subjects who were still moderately impaired after 6 months in their initial treatment arm were allowed to cross over and receive the treatments in the other arm so prior to month 6 no participants randomized to behavior arm were prescribed study medication.
This outcome includes all participants with 2+ growth assessments from the behavior therapy and ER stimulant arms. Doesn't include adaptive randomization arms (drug holiday, cal supplement, monitoring) as they didn't exist until 2nd randomization which did not occur until after this assessment period was over.
Height converted to z score to account for differences in age and gender. More negative values reflecting smaller incremental height gain.
If participant dropped out prior to month 6, then the last assessment point was used.
Measured: baseline to month 6
ADHD Symptoms- Teacher Rated
sum of items on 10 item IOWA Conners with range from 0-30 and larger values indicating greater symptoms. Collected at endpoint or last assessment point.
Measured: month 30 or last assessment point
Medication Adherence
% of study days that study ADHD medication was taken when prescribed to be taken; behavior group could be prescribed medication if moderately impaired still after month 6. Once prescribed, all medication was prescribed to be taken 7 days a week except for in the drug holiday weight recovery arm.
Measured: denominator is number of days in study for which study med was prescribed
Number of Behavior Therapy Sessions
Raw number of behavior therapy sessions attended; participants could cross over to other treatment arm if moderately impaired after 6 months in initial randomly assigned arm
Measured: months 0 through 30
Change in Height z Score During Weight Recovery Phase (Second Randomization)
difference in height z score from entry into weight recovery phase to exit from weight recovery phase (exact duration varied by participant). Randomization could not occur before month 6 (equaling a 24 month duration) but could start as late as month 29 (equaling a 1 month duration) of treatment based on the pattern of zBMI change by the individual participant.
Z scores used to account for differences in age and gender. More negative values reflecting less incremental height gain.
Measured: between 1 month and 24 months
Change in Weight z Score During Weight Recovery Phase (Second Randomization)
difference in weight z score from entry into weight recovery phase to exit from weight recovery phase (exact duration varied by participant). Randomization could not occur before month 6 (equaling a 24 month duration) but could start as late as month 29 (equaling a 1 month duration) of treatment based on the pattern of zBMI change by the individual participant.
Z scores used to account for differences in age and gender. Larger values reflect a greater incremental weight gain.
Measured: 1 to 24 months duration
Change in Zscore for BMI During Weight Recovery Phase (Second Randomization)
difference in BMI z score from entry into weight recovery phase to exit from weight recovery phase (exact duration varied by participant). Randomization could not occur before month 6 (equaling a 24 month duration) but could start as late as month 29 (equaling a 1 month duration) of treatment based on the pattern of zBMI change by the individual participant.
Z scores used to account for differences in age and gender. Larger values reflecting a greater incremental BMI gain.
Measured: between 1 month and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2010 (estimated)
- Study startNov 2010
- Primary completionApr 2016
- Study completionApr 2016
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 (3)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- initial randomization to behavior or extended release stimulant (ER stimulant) arms. Participants in either arm meting criteria for a weight recovery intervention (based on change in zBMI) will be adaptively randomized to one of three weight recovery arms (Monitoring, Drug Holiday, Caloric Supplementation)
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James G Waxmonsky, MD, Principal investigator, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109849
- Sponsor's protocol ID
- R01MH083692
- Status last verified
- Jun 2017
- First submitted
- 21 Apr 2010
- Last updated
- 14 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Waxmonsky JG, Pelham WE 3rd, Baweja R, Hale D, Pelham WE Jr. Predictors of Changes in Height, Weight, and Body Mass Index After Initiation of Central Nervous System Stimulants in Children with Attention Deficit Hyperactivity Disorder. J Pediatr. 2022 Feb;241:115-125.e2. doi: 10.1016/j.jpeds.2021.09.030. Epub 2021 Sep 25.
PubMed 34571023Baweja R, Waschbusch DA, Pelham WE 3rd, Pelham WE Jr, Waxmonsky JG. The Impact of Persistent Irritability on the Medication Treatment of Paediatric Attention Deficit Hyperactivity Disorder. Front Psychiatry. 2021 Jul 21;12:699687. doi: 10.3389/fpsyt.2021.699687. eCollection 2021.
PubMed 34366928Waxmonsky JG, Pelham WE 3rd, Campa A, Waschbusch DA, Li T, Marshall R, Babocsai L, Humphery H, Gnagy E, Swanson J, Hanc T, Fallahazad N, Pelham WE Jr. A Randomized Controlled Trial of Interventions for Growth Suppression in Children With Attention-Deficit/Hyperactivity Disorder Treated With Central Nervous System Stimulants. J Am Acad Child Adolesc Psychiatry. 2020 Dec;59(12):1330-1341. doi: 10.1016/j.jaac.2019.08.472. Epub 2019 Aug 29.
PubMed 31473291
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Approach to Stimulant Induced Weight Suppression and Its Impact on Growth
- ClinicalTrials.gov ID
- NCT01109849
- Acronym / sponsor ID
- R01MH083692
- Keywords
- ADHD, growth, BMI, stimulant medication
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 23 Apr 2010 (estimated)
- Results
- Posted 14 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Previous NIH funded Attention Deficit Hyperactivity Disorder (ADHD) trials in children found that daily stimulant therapy produced sustained growth deficits. However, no federally funded studies have examined the growth suppression associated with modern once a day stimulant medications. Therefore, this study will precisely estimate the risks of stimulant induced growth suppression (SIGS), examine the underlying mechanisms and develop treatments for it. While drug holidays and caloric supplementation are two common treatments for SIGS, there has been little systematic investigation of either. It is unknown if they are effective or feasible. Therefore, using a randomized adaptive design, we will evaluate the efficacy and feasibility of these two practices vs. routine monitoring of growth in 180 prepubertal children with ADHD. An additional 50 subjects will be treated solely with behavioral therapies to evaluate for growth abnormalities associated with ADHD. The study will assess will the risk of SIGS with ER stimulants and the underlying mechanisms while providing evidenced-based treatments for its management.
Detailed description
The study will consist of 4 parts:
- Screening assessment to determine if a child has ADHD and would be a good candidate to have their ADHD treated with an extended release (ER) stimulant medication. If the answer to step one is yes, then the child will be randomly assigned to receive either medication treatment with an extended release MPH product (OROS MPH). 78% of children with start with this option with 22% assigned to behavioral therapy/counseling treatments for ADHD. There will be no placebo treatments used in this study. All children must be between the ages of 5 and 12 and never have taken stimulant medications for ADHD for more than one week to be eligible for the study.
- Initial Treatment Phase: The dose of the assigned treatment option will be gradually adjusted over the course of the first 3 months until the child's ADHD is well controlled. If the child is assigned to medication, he/she will start with a low dose of the ER MPH product, and it will be gradually increased until his/her ADHD is in good control. Children assigned to medication will be asked to take it every day of the week for at least the first 6 months. Children assigned to behavior therapy will be asked to avoid using medication for the first 6 months of the study. After month 6 if the first treatment is not effective, the child will be given the chance to try the other option. If any treatment is causing a concerning side effect, he/she can stop taking it at any time and we will provide him/her with other treatment options as part of the study.
- Ongoing Treatment Phase: We will continue to provide these ADHD treatments for a total of 30 months (2 1/2 years). The dose or type of therapy may be adjusted if needed. The child will be monitored every 1-3 months over this time span. Monitoring includes doctor visits to assess growth and side effects of medication, regular contact with his/her teacher to assess function at school and with you to assess function at home. In total, the child will receive study treatments for approximately 30 months and will be required to come to our center for a minimum of 18 follow up visits over this time. The average visit should take 30 minutes or less.
- Weight Recovery Phase: Any child whose body mass index or BMI declines by a concerning amount will be randomly assigned to receive 1 of 3 weight promotion treatments to stabilize his/her BMI in order to see if this prevents suppression of height (keeps them growing to be as tall as they should be). We do not expect children assigned to the behavior therapy arm to need these treatments, but the identical weight promotion treatments will be available for children in this group if the need arises.
- Extra monitoring: A doctor will check the child's growth every month (instead of every 3 months) until his/her BMI has returned to normal.The child will stay on the current daily dose of medication or behavior therapy.
- Caloric supplementation: Parents will be provided with a flavored calorie drink to give to your child every night and continue on the same daily dose and frequency of medication or behavior therapy. The child will have their growth monitored monthly by a study doctor.
- Drug Holiday: Participants will now only take medication on school days. Children assigned to behavior therapy will not participate in this treatment as they are not taking any study medication. The child will have their growth monitored monthly by a study doctor.
Once the child's weight recovers, these extra treatments will end and he/she will return to the prior medication treatment (medication7 days a week or behavior therapy) in step 3 and to every 3 month growth assessments. Any time the child's BMI declines again, the extra treatments will restart again.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- initial randomization to behavior or extended release stimulant (ER stimulant) arms. Participants in either arm meting criteria for a weight recovery intervention (based on change in zBMI) will be adaptively randomized to one of three weight recovery arms (Monitoring, Drug Holiday, Caloric Supplementation)
| Arm | Type | Receives |
|---|---|---|
| weight recovery treatment- monitoring | Active comparator | Other: monitoringSubjects in either the behavior therapy arm or the medication arm will be assigned to one of 3 treatments if subject does not meet projected BMI goals. In the monitoring arm , participants will continue on their ER stimulant 7 days a week and have their weight, height and BMI checked monthly. |
| behavior therapy | Active comparator | Behavioral: behavior therapy10 week basic parent training, advanced 8 week parent training course. monthly boosters, option for individual parent training sessions, school consultant assigned to each subject |
| ER stimulant | Experimental | Drug: Extended release (ER) methylphenidate productdaily use of 12 hour extended release methylphenidate product |
| weight recovery treatment- caloric supplement | Experimental | Dietary Supplement: caloric supplementSubjects in either the behavior therapy arm or the medication arm will be assigned to one of 3 treatments if subject does not meet projected BMI goals. In the caloric supplement arm, participants will continue on their ER stimulant 7 days a week, have their weight, height and BMI checked monthly and be prescribed a 150 kcal caloric supplement to be consumed every evening. |
| weight recovery treatment- drug holiday | Experimental | Other: drug holidaySubjects in either the behavior therapy arm or the medication arm will be assigned to one of 3 treatments if subject does not meet projected BMI goals. In the drug holiday arm, participants will only take their ER stimulant on school days a week and have their weight, height and BMI checked monthly. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children meeting criteria for any subtype of ADHD between the ages of 5-12 who are stimulant naive
Key exclusion criteria (10 listed)
- Children who meet any of the following criteria will not be eligible to participate in this study:
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 |
|---|---|---|
| behavior therapyAlso: behavior modificationcombination of individual and group parent training plus school consultation | Behavioural | behavior therapy |
| Extended release (ER) methylphenidate productAlso: Concerta, OROS-MPH, Central Nervous Systemt (CNS) stimulantsmedication to be taken daily for duration of study unless assigned to weight promotion arm | Drug | ER stimulant |
| monitoringAlso: monitoring armmonthly weight, height and BMI checks | Other | weight recovery treatment- monitoring |
| drug holidayAlso: Ritalin based product, CNS stimulantsswitch from seven day a week dosing to medication only on school days | Other | weight recovery treatment- drug holiday |
| caloric supplementcontinue current ADHD regimen and add one 8oz liquid caloric supplement at night | Dietary supplement | weight recovery treatment- caloric supplement |
Primary outcome
Change Score for Z-height Baseline to Endpoint
Time frame: month 30 or last assessment point
The primary endpoint will be change in z-height at month 30 which is study endpoint. Measured as a zscore with more negative units reflecting smaller incremental height gain. Z units used to account for differences between groups in gender and age with both impact height at a fixed time.
11 secondary outcomes
Change Score for z Weight
Time frame: baseline to month 30 or to last assessment point
Change in zBody Mass Index (BMI)
Time frame: baseline to month 30 or last assessment point
Treatment Adherence for Caloric Supplement
Time frame: from entry to exit of caloric supplement arm
ADHD Symptoms- Parent Rated
Time frame: at month 30 or last collected assessment point
Change Score for Zheight Months 0 to 6
Time frame: baseline to month 6
ADHD Symptoms- Teacher Rated
Time frame: month 30 or last assessment point
Medication Adherence
Time frame: denominator is number of days in study for which study med was prescribed
Number of Behavior Therapy Sessions
Time frame: months 0 through 30
Change in Height z Score During Weight Recovery Phase (Second Randomization)
Time frame: between 1 month and 24 months
Change in Weight z Score During Weight Recovery Phase (Second Randomization)
Time frame: 1 to 24 months duration
Change in Zscore for BMI During Weight Recovery Phase (Second Randomization)
Time frame: between 1 month and 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34571023Waxmonsky JG, Pelham WE 3rd, Baweja R, Hale D, Pelham WE Jr. Predictors of Changes in Height, Weight, and Body Mass Index After Initiation of Central Nervous System Stimulants in Children with Attention Deficit Hyperactivity Disorder. J Pediatr. 2022 Feb;241:115-125.e2. doi: 10.1016/j.jpeds.2021.09.030. Epub 2021 Sep 25.
- Derived from this study: PubMed 34366928Baweja R, Waschbusch DA, Pelham WE 3rd, Pelham WE Jr, Waxmonsky JG. The Impact of Persistent Irritability on the Medication Treatment of Paediatric Attention Deficit Hyperactivity Disorder. Front Psychiatry. 2021 Jul 21;12:699687. doi: 10.3389/fpsyt.2021.699687. eCollection 2021.
- Derived from this study: PubMed 31473291Waxmonsky JG, Pelham WE 3rd, Campa A, Waschbusch DA, Li T, Marshall R, Babocsai L, Humphery H, Gnagy E, Swanson J, Hanc T, Fallahazad N, Pelham WE Jr. A Randomized Controlled Trial of Interventions for Growth Suppression in Children With Attention-Deficit/Hyperactivity Disorder Treated With Central Nervous System Stimulants. J Am Acad Child Adolesc Psychiatry. 2020 Dec;59(12):1330-1341. doi: 10.1016/j.jaac.2019.08.472. Epub 2019 Aug 29.
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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.
James G Waxmonsky, MD principal investigator
Florida International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing behavior therapy, Extended release (ER) methylphenidate product and monitoring in people with ADHD and Growth, run by Florida International University 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 1 inclusion and 10 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 14 Jul 2017. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 14 Jul 2017). 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 Score for Z-height Baseline to Endpoint (time frame: month 30 or last assessment point). 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 NCT01109849, which also lists 3 linked publications.
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 14 Jul 2017.