Aptensio Xr

Attention Deficit Hyperactivity Disorder
Treatment
1 FDA approval
20 Active Studies for Aptensio Xr

What is Aptensio Xr

DexmethylphenidateThe Generic name of this drug
Treatment SummaryDexmethylphenidate is a medication used to treat Attention Deficit Hyperactivity Disorder (ADHD). It was released in 2002 and works by increasing the levels of two neurotransmitters, norepinephrine and dopamine, in the brain. Dexmethylphenidate has fewer side effects than other forms of methylphenidate and has been found to be more effective at treating symptoms of ADHD.
Ritalinis the brand name
Aptensio Xr Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Ritalin
Dexmethylphenidate
1955
400

Approved as Treatment by the FDA

Dexmethylphenidate, otherwise known as Ritalin, is approved by the FDA for 1 uses including Attention Deficit Hyperactivity Disorder .
Attention Deficit Hyperactivity Disorder
Helps manage Attention Deficit Hyperactivity Disorder (ADHD)

Effectiveness

How Aptensio Xr Affects PatientsDexmethylphenidate is an active form of the drug methylphenidate. It works by blocking the reuptake of two chemicals (norepinephrine and dopamine) in the brain.
How Aptensio Xr works in the bodyMethylphenidate blocks the action of dopamine and norepinephrine in the brain, particularly in the thalamus and striatum. Studies in animals have shown that it affects blood flow in the prefrontal cortex, supplementary motor area, and posterior parietal cortex.

When to interrupt dosage

The measure of Aptensio Xr is based on the diagnosed affliction. The amount of dosage fluctuates in relation to the mode of administration (e.g. Tablet, film coated, extended release or Capsule, extended release) recorded in the table below.
Condition
Dosage
Administration
Attention Deficit Hyperactivity Disorder
, 5.0 mg, 10.0 mg, 20.0 mg, 30.0 mg, 40.0 mg, 15.0 mg, 25.0 mg, 35.0 mg, 2.5 mg, 10.0 mg/mL, 5.0 mg/mL, 18.0 mg, 36.0 mg, 27.0 mg, 54.0 mg, 72.0 mg, 85.0 mg, 55.0 mg, 45.0 mg, 70.0 mg, 80.0 mg, 60.0 mg, 100.0 mg, 50.0 mg, 10.4 mg, 6.0 mg/mL, 5.2 mg, 9.0 mg/mL, 30.0 mg/mL, 7.5 mg/mL, 7.8 mg, 1.0 mg/mL, 2.0 mg/mL
, Oral, Capsule, extended release, Capsule, extended release - Oral, Tablet, Tablet - Oral, Capsule - Oral, Capsule, Solution - Oral, Solution, Tablet, chewable, Tablet, extended release - Oral, Tablet, extended release, Tablet, chewable - Oral, Tablet, Chewable, Extended Release, Suspension, extended release, Tablet, Chewable, Extended Release - Oral, Suspension, extended release - Oral, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral

Warnings

Aptensio Xr has nine counterindications, so it should be avoided for the situations mentioned in the following table.Aptensio Xr Contraindications
Condition
Risk Level
Notes
Gilles de la Tourette syndrome
Do Not Combine
Tension-Type Headache
Do Not Combine
Agitation
Do Not Combine
Pulse Frequency
Do Not Combine
Tourette Syndrome
Do Not Combine
Tics
Do Not Combine
Generalized Anxiety Disorder
Do Not Combine
Open-angle glaucoma
Do Not Combine
Severe Hypersensitivity Reactions
Do Not Combine
Dexmethylphenidate may interact with Pulse Frequency
There are 20 known major drug interactions with Aptensio Xr.
Common Aptensio Xr Drug Interactions
Drug Name
Risk Level
Description
Azelastine
Major
Dexmethylphenidate may increase the central nervous system depressant (CNS depressant) activities of Azelastine.
Desflurane
Major
Dexmethylphenidate may increase the hypertensive activities of Desflurane.
Diethyl ether
Major
Dexmethylphenidate may increase the hypertensive activities of Diethyl ether.
Enflurane
Major
Dexmethylphenidate may increase the hypertensive activities of Enflurane.
Ethanol
Major
Dexmethylphenidate may increase the central nervous system depressant (CNS depressant) activities of Ethanol.
Aptensio Xr Toxicity & Overdose RiskThe effects of dexmethylphenidate are the same for men and women. Not much research has been done on its effects on people under 6 years old, those with kidney or liver disease, pregnant women, or those who are breastfeeding. Those with kidney problems do not need to adjust their dose, as the drug is not mainly cleared from the kidneys. Animal studies have shown delayed bone growth in unborn babies and reduced weight gain in male offspring. It is important to weigh the benefits and risks of taking this drug. The maximum recommended human dose in mice caused hepatoblastomas (liver tumors), and it can be weakly clastogenic
image of a doctor in a lab doing drug, clinical research

Aptensio Xr Novel Uses: Which Conditions Have a Clinical Trial Featuring Aptensio Xr?

Research is ongoing to determine the efficacy of Aptensio XR in the management of Attention Deficit Hyperactivity Disorder, with 77 active studies currently being conducted.
Condition
Clinical Trials
Trial Phases
Attention Deficit Hyperactivity Disorder
63 Actively Recruiting
Not Applicable, Phase 3, Phase 4, Phase 1, Phase 2

Aptensio Xr Reviews: What are patients saying about Aptensio Xr?

3.3Patient Review
5/15/2016
Aptensio Xr for Attention Deficit Disorder with Hyperactivity
2.7Patient Review
10/25/2016
Aptensio Xr for Attention Deficit Disorder with Hyperactivity
We're still testing dosages to see what will work for my daughter, but so far this has been fairly effective.

Patient Q&A Section about aptensio xr

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Aptensio XR a controlled substance?

"Aptensio XR contains methylphenidate, a Schedule II controlled substance."

Answered by AI

Is Aptensio the same as Ritalin?

"Aptensio XR is a once-daily methylphenidate medication with the same active ingredient as Ritalin and Daytrana. It is available in capsule form in 10, 15, 20, 30, 40, 50, and 60 mg doses."

Answered by AI

What is Aptensio XR used for?

"This medication is used to treat attention deficit hyperactivity disorder (ADHD). It works by changing the amounts of certain natural substances in the brain. Methylphenidate belongs to a class of drugs known as stimulants."

Answered by AI

Is Aptensio XR like Adderall?

"Aptensio XR takes longer to start working than other forms of instant release medication, such as Ritalin, but it lasts up to 12 hours. Other medications, such as Adderall, are also available in extended release versions which last for the same amount of time."

Answered by AI

Clinical Trials for Aptensio Xr

Image of St. Jude Children's Research Hospital in Memphis, United States.

Methylphenidate for Sickle Cell Disease

8 - 17
All Sexes
Memphis, TN
The purpose of this study is to determine if patients with sickle cell disease (SCD) can consistently take a drug called Methylphenidate (MPH) daily, once a day for 4 weeks to help with any thinking, attention or schoolwork problems and if they have any side effects. The study will assess any thinking or attention problems participants may have both before taking this drug and after. Additionally, the study will assess the decision-making process of the caregiver that may influence using this drug or not. Primary Objective: • Assess the feasibility, acceptability, and adherence to MPH treatment in children with SCD and EF deficits. Secondary Objective: • Evaluate neurobehavioral and safety outcomes following MPH treatment. Exploratory Objective: • Evaluate decision-making and determinants influencing methylphenidate utilization among parents.
Phase 1
Recruiting
St. Jude Children's Research HospitalAndrew Heitzer, PhD
Image of The University of Iowa in Iowa City, United States.

fMRI for Cognitive Flexibility

18 - 35
All Sexes
Iowa City, IA
The goal of this basic experimental research study is to examine how the human thalamus supports flexible thinking and behavior. Specifically, the research aims to elucidate how the mediodorsal (MD) thalamus encodes and updates "context"-the mental framework that determines which rules or actions are relevant in a given situation. This work may contribute to understanding why certain psychiatric conditions, such as schizophrenia and ADHD, involve difficulties with cognitive flexibility and control. The primary research questions are: Does the MD thalamus represent the context that organizes how working memory guides task selection? Does the MD thalamus signal when context needs to be updated after a change in task demands? Do these thalamic representations support generalization to new situations or rules? Participants will complete cognitive tasks while undergoing high-resolution brain imaging using 7-Tesla MRI. The investigators will combine behavioral data, computational modeling, and advanced neuroimaging analyses to examine how the thalamus interacts with the cortex during flexible decision-making.
Waitlist Available
Has No Placebo
The University of Iowa
Image of UCSF Nancy Friend Pritzker Psychiatry Building in San Francisco, United States.

Trigeminal Nerve Stimulation for ADHD in Children with Autism

7 - 14
All Sexes
San Francisco, CA
The goal of this clinical trial is to learn if external trigeminal nerve stimulation (eTNS) works to treat ADHD symptoms in children on the autism spectrum (ASD). It will also learn about the efficacy and tolerability of the eTNS device. The main questions it aims to answer are: * Does eTNS reduce ADHD symptoms? * Does eTNS improve core and associated features of ASD? Participation spans 8-12 weeks and includes: * 4-5 in-person visits * 4 brief virtual check-ins * Nightly use of the eTNS device with a small sticky patch applied to child's forehead * Randomized assignment (those who start with the sham device may try the active device later)
Recruiting
Device
UCSF Nancy Friend Pritzker Psychiatry Building
Have you considered Aptensio Xr clinical trials? We made a collection of clinical trials featuring Aptensio Xr, we think they might fit your search criteria.Go to Trials
Image of Hoskinson Health and Wellness Clinic in Gillette, United States.

Biofeedback and Lifestyle Interventions for ADHD

7 - 18
All Sexes
Gillette, WY
The Pediatric Healing Minds II intervention includes a biofeedback component, breathing practices nutrition and exercise counseling. Biofeedback is a type of mind-body technique used to control body functions such as heart, lung and muscle responses. Biofeedback uses therapeutic techniques that aim to help study participants gain more awareness and control over certain physiological functions in their bodies. It involves the use of electronic monitoring equipment to provide real-time information about physiological processes such as heart rate, HRV, coherence and muscle tension. This information is then provided back to the study participant, allowing them to learn how to consciously regulate these processes. During the sessions parents are expected to attend and participate. Study participants and parents will have access to a video that provides instructions for placement of the Heart Math single small ear lobe or finger sensor. Breathing Practices include alternate nostril, qi gong and other breathing practices. Nutrition counseling includes nutrition supplementation to correct deficiencies, dietary education and an age-and gender-specific diet prescription based on the Mediterranean Diet. Exercise counseling includes developmentally appropriate guidelines for cardiopulmonary, strength and flexibility activities based on guidelines from the American College of Sports Medicine (ACSM) and the American Academy of Pediatrics (AAP). The objective of this research proposal is to examine the combined effects of an integrative approach including biofeedback, breathing practices, nutrition and exercise counseling intervention (Healing Minds II), on symptoms and severity of ADHD, impulsivity and attention (e.g., QB continuous performance test) in youth 7-18 years of age. The investigators hypothesize that ADHD symptoms and severity, impulsivity and attention will be significantly improved and coherence increased after participation in the 6-month intervention. The investigators also propose that ADHD severity in those patients with prescribed medication but poorly-controlled ADHD will demonstrate the greatest improvement compared to those not prescribed medication and those who have well-controlled ADHD.
Waitlist Available
Has No Placebo
Hoskinson Health and Wellness ClinicInara McMaster, MDHoskinson Health and Wellness Clinic
Image of Louisiana State University in Baton Rouge, United States.

Virtual Reality for ADHD

18 - 25
All Sexes
Baton Rouge, LA
The goal of this larger parallel group randomized trial is to test the impact of a virtual reality program for improving the ability of emerging adults (age 18-25) with attention deficit hyperactivity disorder (ADHD) to stay focused while completing homework and studying. This study compares the impact of using a virtual reality headset to using a virtual reality headset while also receiving feedback about levels of focus to a control group. The main question is whether participants demonstrate significantly improved concentration while completing homework and studying in virtual reality and whether they enjoy and prefer working in a virtual reality environment. Concentration is measured both through participant report and also using keyboard and mouse click data to assess work productivity objectively.
Phase 4
Waitlist Available
Louisiana State University (+1 Sites)Joshua M Langberg, PhD
Image of Duke University in Durham, United States.

Organizational Skills Training vs Mindfulness for ADHD

13 - 17
All Sexes
Durham, NC
This randomized control trial comparing Organizational Skills Training (OST) and Mindfulness-Based Intervention (MBI) among adolescents with a pre-existing ADHD diagnosis presenting to the Duke ADHD Program. Both treatments are eight 90 minute sessions. The research component will involve a pre-treatment assessment and post-treatment assessment. Both assessments will involve adolescents and one caregiver to complete questionnaires over REDCap. Rating scales will include ADHD symptom severity (Conners 3: self and parent report), functional impairment (IRS: self and parent report), executive functioning (BRIEF-2: parent report), emotion dysregulation (DERS: self and parent report), trait mindfulness (FFMQ: self report), organizational skills (BRIEF-2: parent report), treatment satisfaction (self report and parent report) and credibility (self report and parent report). Post-treatment assessments for feasibility will include attendance (measured over the course of treatment) and homework completion rates on a scale of 1 to 5 in which 5 indicates higher homework completion. We will also assess acceptability via individual items on a Likert scale (self report): overall satisfaction, how much was learned about ADHD, usefulness of information learned, content relevance to individual experience, comprehension of strategies, confidence about using strategies, likelihood of using strategies, helpfulness to share with the group, benefits from hearing from other group members, willingness to recommend the same treatment to others, and whether or not treatment was beneficial.
Recruiting
Has No Placebo
Duke UniversityJohn Mitchell, PhD
Have you considered Aptensio Xr clinical trials? We made a collection of clinical trials featuring Aptensio Xr, we think they might fit your search criteria.Go to Trials
Image of Montana State University in Bozeman, United States.

Speech-Gesture Combinations for Autism

Any Age
All Sexes
Bozeman, MT
This research study investigates how hand gestures can support language comprehension and communication skills of hearing speaking, non-speaking, and/or minimally verbal individuals with Autism Spectrum Disorders (ASD), who are especially disadvantaged by the lack of accessible services in their rural communities. Individuals with other cognitive profiles, including Developmental Language Disorder (DLD), ADHD, Dyslexia, and others are welcome too. The study uses methods of eye tracking and recording of brain activity to understand how hand gestures adapted from signs from American Sign Language, such as \[cry\], can promote successful understanding of words like "cry". The overarching goal is to help families effectively utilize gestures to support communication with their children.
Recruiting
Has No Placebo
Montana State University
Image of University of Pennsylvania in Philadelphia, United States.

Measurement Feedback App for Autism Spectrum Disorder

18+
All Sexes
Philadelphia, PA
The goal of this clinical trial is to test whether a smartphone-based data collection and feedback application ("Footsteps") improves the quality of behavioral data collected by one-to-one aides and leads to better youth mental health outcomes in school-aged youth (ages 4-17) who receive one-to-one support in schools. The main questions it aims to answer are: 1. Does the Footsteps app improve aides' data collection quality (i.e., consistency, timeliness, and completeness)? 2. Does Footsteps use lead to improved youth behavioral health outcomes (e.g., SDQ, YTP, GAS scores)? 3. Does Footsteps improve communication and supervision processes between aides and clinical supervisors? Researchers will compare aides using Footsteps to those using a "data collection only" control app to see if Footsteps leads to higher quality data collection, enhanced supervisory communication, and better youth outcomes. Participants will: * Use either Footsteps or a control app to record de-identified data on one client's behaviors and skills over 12 weeks * Complete biweekly online surveys about data collection experiences, youth progress, and aide-supervisor communication * Participate in a virtual intake and post-trial meeting * (For a subset) Participate in a 30-45 minute qualitative interview about their experience using the app
Waitlist Available
Has No Placebo
University of PennsylvaniaHeather J Nuske, PhD
Image of Boston Children's Hospital Laboratories of Cognitive Neuroscience in Brookline, United States.

Guided Deep Breathing for ADHD

7 - 11
All Sexes
Brookline, MA
Attention-deficit/hyperactivity disorder (ADHD) affects approximately 11% of children and adolescents in the United States. Individuals with ADHD experience substantial impairments and burdens across multiple areas of daily living, including peer difficulties, academic difficulties, poor job outcomes, high rates of co-occurring disorders, and large financial costs. Although there are many well-established, evidence-based treatments for ADHD, many children continue to experience significant impairment and elevated ADHD symptoms even with prolonged treatment. Further, there are several limitations to existing treatment approaches, including medication side effects, difficulty accessing behavioral treatments, and high out-of-pocket costs for behavioral treatments. Thus, there is a crucial need to identify low cost, low burden, alternative or additive intervention approaches for pediatric ADHD. In the current pilot study, we aim to evaluate responses in behavioral and brain-based markers of attention to a mindfulness-based intervention. Mindfulness-based interventions (MBIs), including deep breathing, have received considerable research attention regarding their benefits for ADHD symptoms. Deep breathing is a strong candidate as a supplementary MBI intervention for children with ADHD due to its simplistic and easy-to-implement nature. Studies examining the effects of deep breathing on physiological arousal and ADHD symptoms in children have yielded promising results. Children will be led through a brief deep breathing intervention using a novel tool designed to optimize child engagement in deep breathing. This tool, Domi, is designed to be held in the child's hands and uses a series of haptic vibrations to provide real-time deep breathing pacing guidance. We predict that following a brief deep breathing practice, children with ADHD will demonstrate improved sustained attention, reaction time consistency, and inhibitory control. These areas of attention and behavioral functioning will be assessed using computer tasks and measures of brain activity. We plan to use the results of this study to strengthen a future application for grant funding to run a similar trial with many more children. We believe that the results of this and future studies will improve the lives of children with ADHD and their families.
Waitlist Available
Has No Placebo
Boston Children's Hospital Laboratories of Cognitive Neuroscience
Image of UPMC Magee-Womens Hospital in Pittsburgh, United States.

MomMA Intervention for ADHD

18+
Female
Pittsburgh, PA
The goal of this study is to test a behavioral program for pregnant individuals with ADHD. This behavioral program focuses on skills for managing ADHD and related symptoms in pregnancy and postpartum. This pilot effectiveness-implementation trial aims to (1) preliminarily evaluate the MomMA behavioral intervention compared to treatment as usual (TAU) on clinical outcomes and (2) evaluate implementation outcomes, including feasibility and acceptability of clinic screening within existing OB workflows; assessment and intervention protocols; provider training/fidelity to manual; and all other study protocols from the perspective of real-world providers and participants.
Waitlist Available
Has No Placebo
UPMC Magee-Womens HospitalHeather M Joseph, DO Assistant Professor of Psychiatry and Pediatrics
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