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Search Results Within Category "ADD/ADHD"

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8 Study Matches

Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD

This study will evaluate the efficacy and safety of SPN-812 (viloxazine extended release) in children 4 to 5 years of age with ADHD.

ADHDResearch@cchmc.org

ALL
48 months to 69 months old
PHASE4
This study is NOT accepting healthy volunteers
NCT04781140
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Inclusion Criteria:

• Is male or female 4 years 0 months of age to less than or equal to 5 years 9 months of age at Visit 1 (Screening) and considered medically healthy.
• Subject's parent(s) or legal guardian(s)/representative(s) is (are) willing and able to provide written informed consent before completing any study related procedures.
• Has a primary diagnosis of ADHD according to DSM-IV-TR criteria and confirmed with the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version (K-SADS-PL).
• Has an ADHD-RS-IV-P Total Score of ≥ 28 (males) or ≥ 24 (females) at Visit 1 (Screening) and at Visit 2 (Baseline).
• Has a CGI-S score of ≥ 4 (moderate or worse) at Visit 1 (Screening) and at Visit 2 (Baseline).
• Has undergone an adequate course of non-pharmacologic treatment or is having symptoms severe enough to warrant pharmacologic treatment without prior non-pharmacologic treatment.
• Is participating in a structured group activity (e.g., preschool, kindergarten, sports, Sunday school, summer camp or childcare program) at least 2 days a week during study so as to assess symptoms and impairment in a setting outside the home.
• Has not initiated any behavioral intervention/therapy within 30 days of Visit 1 (Screening) and does not plan to initiate any new or discontinue any ongoing behavioral intervention/therapy during the study (e.g., subject is eligible if behavioral intervention/therapy is initiated 30 or more days prior to Visit 1 \[Screening\] and continues with a similar duration/frequency throughout their study).
• Subjects who are on ADHD medication at Visit 1 (Screening), but whose ADHD symptoms are not well controlled on current ADHD medication (e.g., meets Inclusion Criterion #4), meet all other inclusion/exclusion criteria, and discontinues ADHD medication at least 7 days prior to the day of Visit 2 (Baseline) are eligible to participate.
• Has no current condition in the opinion of the Investigator that could confound efficacy assessments, safety assessments or increase participant risk.
• Has lived with the same parent(s) or legal guardian(s) or has lived under a shared living arrangement (e.g., joint legal custody) for greater than or equal to 6 months prior to Visit 1 (Screening).
• Has a body weight ≥5th percentile for age and sex at Visit 1 (Screening) and Visit 2 (Baseline).
Exclusion Criteria:

• Has a diagnosis at Screening (per K-SADS-PL) of another psychiatric disorder that is considered to be the primary diagnosis rather than ADHD or has a comorbid psychiatric disorder secondary to ADHD that, in the opinion of the investigator (after consulting medical monitor), will likely interfere with study treatment adherence and/or impact study results.
• Has a current diagnosis of a major neurological disorder. The eligibility of those who have seizures, a history of seizure-like events (e.g., syncope, myoclonus, severe muscle spasms), a family history of seizure disorder (immediate family, i.e., sibling, parent), and/or febrile seizures will be assessed on a case-by-case basis after consulting the medical monitor.
• History of Bipolar Disorder diagnosed in a first degree relative.
• Has global development delay or intellectual disability by medical history.
• Has a current diagnosis of a significant (per Investigator's evaluation and/or judgement) systemic disease.
• Has body mass index \> 95th percentile for the subject's age and sex at Visit 1 (Screening) or Visit 2 (Baseline).
• Has a mean resting systolic and diastolic blood pressure\* that are both \>95th percentile for age sex, and height and has a mean resting pulse rate\* that is \>95th percentile for age and sex (males: \>117 bpm; females: \>122 bpm) at Visit 1 (Screening) or Visit 2 (Baseline). \* Note: The mean of three measurements while seated.
• Has a clinically significant electrocardiogram finding(s) at Visit 1 (Screening).
• Is currently taking SPN-812 for ADHD, has previously taken SPN-812 for ADHD, but discontinued due to a lack of efficacy or adverse reactions, or has history of allergic reaction, hypersensitivity or intolerance to viloxazine.
• Has an allergy to or cannot swallow pudding and applesauce and cannot swallow intact capsule whole.
• Has any food allergy, intolerance, restriction or special diet that, in the opinion of the Investigator, could contraindicate the subject's participation in the study.
• Has received any investigational drug within the longer of 30 days or 5 half-lives prior to Visit 2 (e.g., first dose of study medication).
• Has a positive urine drug test at Visit 1 (Screening). A positive test for amphetamines is allowed for subjects receiving a stimulant ADHD medication at Screening. The subject will be required to discontinue the stimulant for the duration of the study, beginning at least 7 days prior to Visit 2 (Baseline).
• Is using of prohibited concomitant medications including known CYP1A2 substrates (e.g., theophylline, melatonin) during the Screening Period or (anticipated) for the duration of the study.
• Any reason that, in the opinion of the Investigator, would prevent the subject from participating in the study.
• Has suicidal ideation ("Yes" indicated on C-SSRS question 4 or 5) or suicidal behavior ("Yes" indicated on C-SSRS for any suicidal behavior) within 6 months prior to or the day of Visit 1 (Screening) or has attempted suicide ("Yes" indicated on C-SSRS for lifetime).
DRUG: 100mg SPN-812, DRUG: Placebo
Attention-Deficit/Hyperactivity Disorder
ADHD
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Carboxylesterase 1 Genetic Variation and Methylphenidate in ADHD

The study team will determine the association between d,l-methylphenidate (MPH) therapeutic outcomes in ADHD patients and genetic variants of CES1 and reveal key associations between CES1 genotypes and the PK and PD of MPH.

Simon Abimosleh - simon.abimosleh@cchmc.org

ALL
6 years to 17 years old
PHASE4
This study is NOT accepting healthy volunteers
NCT03781752
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Inclusion Criteria:
\- Youth ages 6-17 years with ADHD as a primary diagnosis
Exclusion Criteria:
* Participants that do not have ADHD as a primary diagnosis * Participants that do not want, require, or are not healthy enough for a single dose trial of MPH for ADHD per the clinical judgment of the treating and study clinicians * Participants that are smokers or, are pregnant
DRUG: Methylphenidate
ADHD, Attention Deficit Hyperactivity Disorder
PK Study, PD Study, Pharmacokinetics, Pharmacodynamics, Methylphenidate, MPH
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Improving ADHD Teen Driving - Virtual Reality

Teens with Attention-Deficit/Hyperactivity Disorder (ADHD) have high rates of negative driving outcomes, including motor vehicle crashes, which may be caused by visual inattention (i.e., looking away from the roadway to perform secondary tasks). Two versions of a driving intervention that trains teens to reduce instances of looking away from the roadway will be tested in teens with ADHD.

- ADHDdriving@cchmc.org

ALL
16 years to 19 years old
NA
This study is NOT accepting healthy volunteers
NCT06960980
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Inclusion Criteria:

• Aged 16-19.
• Teens will meet DSM ADHD criteria for ADHD-Predominantly Inattentive Presentation or ADHD-Combined Presentation based on the K-SADS interview.
• Possess a valid driver's license and regularly spend at least 3 hours per week engaged in unsupervised driving.
• IQ ≥80 as measured by the Kauffman Brief Intelligence Scale - Second Edition (KBIT-2).
• Parent willing to participate.
Exclusion Criteria:

• On ADHD medication that cannot be washed out on assessment days.
• Drug or alcohol dependence based on self-report on the Simple Screening Instrument for Alcohol and Other Drugs survey.
• On psychotropic or neuroleptic medications.
• At-risk for motion sickness in the driving simulator or in virtual reality.
• History of moderate to severe head trauma, neurological disorder, or any other organic disorder that could possibly affect brain function.
• Cannot see the secondary task stimuli without the use of glasses (contacts acceptable).
BEHAVIORAL: FOCAL+, BEHAVIORAL: VR-FOCAL+
Attention Deficit Hyperactivity Disorder (ADHD)
Visual attention, Automobile Driving
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Biomarker Validation in Motor System Physiology in Attention Deficit Hyperactivity Disorder (AMPAIII)

Attention-Deficit/Hyperactivity Disorder (ADHD) is the most commonly diagnosed neurobehavioral disorder in childhood. Children with ADHD struggle in school due to problems with attention and high levels of impulsivity and hyperactivity. They are at substantially increased risk for long-term difficulties into adulthood, including academic underachievement, substance abuse, and criminal behavior. The diagnosis of ADHD, which is based on subjective ratings by parents and teachers, likely results from multiple different, overlapping differences in circuits of the brain responsible for attention and impulse control. However, we do not have any scientific or clinical tests that allow us to understand these circuits. In an effort to improve ADHD outcomes, we have used a technology called Transcranial Magnetic Stimulation (TMS) to identify highly reliable measurements of brain function. We have identified two very promising measures that are abnormal in children with ADHD and, importantly, also predict the severity of ADHD behaviors. The goal of this project is to determine if these two TMS measurements could be used to help better guide ADHD treatment. To do this, we will perform three investigations in 8 to 12 year old children to determine: 1) test-retest reliability; 2) pharmacologic responsiveness; and 3) correlations with two domains of function relevant to ADHD: "Cognitive Control" and "Emotional Valence." Through these investigations, we aim to determine whether these two TMS brain measures are reliable and meaningful enough to be used to help improve precision of individually-targeted and effective ADHD treatments.

Karlee Migneault - karlee.migneault@cchmc.org

ALL
8 years to 12 years old
PHASE4
This study is also accepting healthy volunteers
NCT04421248
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Inclusion Criteria:
* Either gender, any race, ethnicity or socioeconomic status * Currently between 8 years 0 months and 12 years, 11 months, 30 days * Willing to answer questions about ADHD and related diagnoses * For children with ADHD prescribed stimulant medications, willing to suspend taking medications as specified in the study procedures * For children with ADHD, willing to participate in the single dose, randomized crossover study to probe acute effects of methylphenidate on biomarkers * Right hand dominant (predominately right-handed) * Able to participate in and sign an informed consent * ADHD inclusion: The diagnosis of ADHD will be based on Diagnostic and Statistical Manual version 5 (DSM-5) criteria using standard rating scales and a structured diagnostic interview. Oppositional Defiant Disorder is permitted; Conduct disorder is excluded. * Typically Developing (healthy control) inclusion: Free of ADHD or other developmental or psychiatric disorders based on DSM-5 criteria using standard rating scales and a structured diagnostic interview.
Exclusion Criteria:
* Known diagnosis of mental retardation, cerebral palsy, Autism Spectrum Disorder, traumatic brain injury, brain tumor, epilepsy, or other serious neurological disorder. * Major Depression, Bipolar Disorder, Conduct Disorder, Adjustment Disorder, other Anxiety Disorders, or other developmental psychiatric diagnoses. * For females, onset of menses, pregnancy. * Current use of antidepressants, non-stimulant ADHD medications, dopamine blocking agents, mood stabilizers. * Implanted brain stimulator, vagal nerve stimulator, ventriculo-peritoneal shunt, cardiac pacemaker, or implanted medication port. * Diagnosis of a speech/language disorder or a Reading Disability (RD).
DRUG: Methylphenidate, DRUG: Placebo
Attention Deficit Hyperactivity Disorder Combined
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Treating Young Children With Attention Deficit Hyperactivity Disorder (TYCA)

This project will evaluate the effectiveness of Methylphenidate versus Guanfacine in treating Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged 3 through 5 years (inclusive), as measured by clinician rating of global improvement.

Hannah Bush, MA - ddbp.adhd.research@cchmc.org

ALL
3 years to 5 years old
PHASE4
This study is NOT accepting healthy volunteers
NCT07300956
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Inclusion Criteria:

• Males or females 3 to 5 years of age, inclusive (e.g. children age 5 years, 11 months are eligible).
• Child has a confirmed diagnosis of moderate or severe Attention-Deficit/Hyperactivity Disorder (diagnostic code: F90.9) based on Diagnostic and Statistical Manual of Mental Disorders - 5th Edition (DSM-5) criteria, review of supportive evidence (caregiver interview, behavioral observations, Vanderbilt Attention-Deficit/Hyperactivity Disorder Rating Scale results, any school or daycare information provided by caregiver).
• Clinician-rated Clinical Global Impairment-Severity (see description below) rating of ≥4 (denoting moderate or greater impairment due to their Attention-Deficit/Hyperactivity Disorder symptoms).
• The child's clinician and caretakers have decided on or are considering initiating drug therapy (with either Methylphenidate or Guanfacine).
• Primary language is English or Spanish.
Exclusion Criteria:

• History of taking Methylphenidate or Guanfacine. Prior use of other Attention-Deficit/Hyperactivity Disorder medications or other psychotropic medications is allowed.
• Current use of other Attention-Deficit/Hyperactivity Disorder medications (e.g., amphetamines), other psychotropic medications (e.g., atypical antipsychotics or serotonin reuptake inhibitors), or centrally active depressants (such as phenothiazines, barbiturates, or benzodiazepines)
• Electronic Health Record documentation of moderate to severe global developmental delay (F88) or intellectual disability (F70), or a score of \<55 on the Vineland Adaptive Behavior Scales-3.
• Medical contraindications to taking Methylphenidate or Guanfacine, including cardiac risk factors (e.g. known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac disease), increased intraocular pressure, glaucoma, verbal tics, Tourette's Syndrome, psychosis
DRUG: Guanfacine (GUA), DRUG: Methylphenidate (MPH)
Attention-Deficit/Hyperactivity Disorder (ADHD)
Attention-Deficit/Hyperactivity Disorder, Methylphenidate, Guanfacine, Preschool Children, Comparative Effectiveness, Prospective Study
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Impact of Short and Mistimed Sleep on Adolescents With ADHD: The Adolescent Attention and Circadian Timing Study (AACT)

Many adolescents go to bed late and wake up early for school. Science is only beginning to understand how sleep schedules can affect them. The investigators are interested in whether changing adolescents' sleep patterns affects their functioning, attention, and how they feel. The investigators are especially interested in the effects of changing both how much sleep adolescents get and when that sleep happens. This study focuses on healthy 13-17-year-olds with ADHD. This study asks adolescents to systematically change their sleeping habits across a 3 week span. The first week, they follow a sleep schedule that fits reasonably well with the schedule they keep when they do not have to wake up early for any specific obligation (e.g., for school). The second week, they spend several nights in a "short sleep" condition, during which they get 6.5 hours in bed per night. The final week, they enter a sleep condition that allows for healthy sleep duration, but with a timing that is randomly assigned to either fit well with their preferred schedule or fit poorly with that schedule. During each week, they and their parents complete measures of their attention and other factors. At the end of each week, they attend an evening session to measure their internal body clock ("circadian phase"), as well as measures of attention and other thinking skills. The goal is to understand whether the benefits of healthy sleep duration depend on the timing of when that sleep occurs.

- teensleep@cchmc.org

ALL
13 years to 17 years old
NA
This study is NOT accepting healthy volunteers
NCT07684417
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Inclusion Criteria:
* Ages 13-17 years at time of informed consent/assent * Based on semi-structured clinical interview, participants must meet full DSM-5 criteria for ADHD inattentive or ADHD combined presentation.
Exclusion Criteria:
* Non-traditional school setting (morning-afternoon Monday-Friday). * Exclusionary diagnoses. We will exclude adolescents with known intellectual disability, autism spectrum disorder, psychosis, bipolar disorder, or neurologic conditions (e.g., epilepsy), per caregiver-report. * Exclusionary sleep disorders. We will exclude adolescents with symptoms of obstructive sleep apnea or periodic limb movement disorder based on published cutoffs on a validated questionnaire. * High caffeine intake. To promote adherence to directives not to consume caffeine the day of office visits without withdrawal effects, adolescents with daily intake of \>1 coffee or "energy drink" or \>2 caffeinated sodas per day based on caregiver- and adolescent-report will be excluded. * Unwillingness or inability to take part in study procedures (e.g., visits, prescribed sleep conditions). * Medication use or unwillingness to discontinue melatonin and/or stimulant medications during the 3-week study protocol. * Refusal to refrain from automobile driving during the sleep restriction condition. * "Intermediate" Chronotypes (neither morning larks nor night owls) based on habitual sleep timing on nights when adolescent has no morning obligations such as school or work.
BEHAVIORAL: Aligned sleep extension, BEHAVIORAL: Misaligned sleep extension
ADHD
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ADHD PreSMA Response Inhibition Therapy

ADHD children have abnormal inhibitory control, meaning they have trouble stopping themselves from doing something they should not do. This ability to control involves an area in the brain called the pre-supplementary motor area (pre-SMA). Scientists have previously shown that the pre-SMA is abnormal in ADHD patients. In this study, we will use Transcranial Magnetic Stimulation (TMS) to stimulate the pre-SMA and determine the effects on measures that are related to inhibitory control.

Karlee Migneault - karlee.migneault@cchmc.org

ALL
12 years to 17 years old
NA
This study is NOT accepting healthy volunteers
NCT06325813
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Inclusion Criteria:

• ADHD diagnosis
• Ages 12-17 years
• Stimulant use is allowed but must be discontinued 24 hours prior to and during days of TMS visit
Exclusion Criteria:

• Medical conditions contraindicated or associated with altered TMS risk profile, including history of intracranial pathology, epilepsy or seizure disorders, traumatic brain injury, brain tumor, stroke, intellectual disability, cerebral palsy, neurodegenerative conditions, hearing impairment, metallic objects in the head or any other serious medical condition
• Presence of any implanted medical devices (e.g., ports, shunts, stimulators, cochlear implants)
• For biological females who are post-menarche, current pregnancy based on urine pregnancy test.
• Baseline problem of hearing impairment or chronic tinnitus
• Any clinically significant finding on brain MRI
• History of DSM-5 conduct disorder, major depressive disorder, bipolar disorder, obsessive compulsive disorder, anxiety disorder, psychotic disorder
• Non-stimulant medication(s) for ADHD (e.g., alpha2 adrenergic agonist, atomoxetine, tricyclics)
• Neuroleptic/antipsychotic medication(s)
• Inability to undergo MRI
• Active suicidality, history of suicidality, or high risk for suicide as assessed by a study physician
• Substance abuse or dependence within the past year, based on 1) separate screening process of asking parent/guardian and participant, and 2) positive urine drug screen. Exception will be made for positive urine drug screen due to prescribed ADHD medication
DEVICE: Active repetitive TMS, DEVICE: Sham repetitive TMS
Attention Deficit Hyperactivity Disorder
ADHD, Transcranial Magnetic Stimulation
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AWARE: Management of ADHD in Autism Spectrum Disorder

This study is a pragmatic clinical trial examining the comparative effectiveness of two stimulant medications (methylphenidate and amphetamine) in the treatment of ADHD in children and adolescents with autism. Using a sequential, multiple assignment randomization trial (SMART) design the study will not only assess these two medications but also the role of an increasingly popular class of ADHD medication, the alpha-2 agonists. Findings from this study will help improve clinicians' approach to medication selection and reduce the repeated trials of multiple medications that are current standard care.

Courtney Herberger - Courtney.Herberger@cchmc.org

ALL
4 years to 17 years old
PHASE4
This study is NOT accepting healthy volunteers
NCT05916339
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Inclusion Criteria:

• Participant and/or legal caregiver must be willing and able to give informed consent/assent for participation in this study.
• Participant and/or legal caregiver must be willing and able (in the Investigator's opinion) to comply with all study requirements.
• Participant must be between 4 and 17 years of age (inclusive) at time of enrollment.
• Participant must have a confirmed diagnosis of ASD based on supportive evidence (e.g. referring physician's report, medical records, such as ADOS or CARS, etc.).
• Participant must have the ability to consistently take medication (via pill, liquid or mixed with food/liquid).
• Participant must have a confirmed diagnosis of ADHD (based upon DSM-5 criteria and supportive evidence).
• Participant must have a consistent reporter (e.g., parent) who spends regular time with the child.
• Participant can be on other psychotropic medications (selective serotonin reuptake inhibitor (SSRI), atypical antipsychotic, anticonvulsant) if dose has been stable for \> 4 weeks prior to consent with no plans for a dose change during the study.
• It has been at least 7 days since the participant last took an ADHD medication and the presiding clinician believes this to be a sufficient amount of time.
• Caregiver must be sufficiently fluent in English or Spanish to be able to complete questionnaires relevant to this study.
Exclusion Criteria:

• Participant has taken ADHD medication within the past 7 days.
• Participant is not stable on other medications (\< 4 weeks).
• Any other risk factor that might prevent patient from safely taking the study medications. * There are no inclusion/exclusion criteria based upon participant IQ. We will include individuals across the entire range of cognition, just as practitioners are asked to treat ADHD in children with ASD across the entire IQ range.
DRUG: Randomization to either Amphetamine (AMP) class of stimulant medication or Methylphenidate (MPH) class of stimulant medication, DRUG: Randomization to either Alpha 2 agonist class of medication or alternate class of stimulant.
ADHD, Autism Spectrum Disorder
ADHD, Autism, ASD
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