Aptensio Xr

Attention Deficit Hyperactivity Disorder

Treatment

1 FDA approval

20 Active Studies for Aptensio Xr

What is Aptensio Xr

Dexmethylphenidate

The Generic name of this drug

Treatment Summary

Dexmethylphenidate 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.

Ritalin

is 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 Patients

Dexmethylphenidate 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 body

Methylphenidate 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, Capsule - Oral, Solution - Oral, Solution, Tablet, chewable, Tablet, extended release, Tablet, extended release - Oral, Tablet, chewable - Oral, Suspension, extended release - Oral, Suspension, extended release, Tablet, Chewable, Extended Release, Tablet, Chewable, Extended Release - Oral, Tablet, film coated, extended release - Oral, Tablet, film coated, extended release

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 Risk

The 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?

3.3

Patient Review

5/15/2016

Aptensio Xr for Attention Deficit Disorder with Hyperactivity

2.7

Patient 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 Seattle Children's Hospital in Seattle, United States.

Organizational Skills Training vs Mindfulness for ADHD

13 - 17
All Sexes
Seattle, WA

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

Seattle Children's Hospital

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 Hospital

Andrew Heitzer, 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 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

Image of The University of Texas at Austin in Austin, United States.

Transcranial Photobiomodulation for ADHD

18 - 44
All Sexes
Austin, TX

The investigators have previously shown that non-invasive methods of brain stimulation such as the administration of transcranial infrared light to the prefrontal cortex (PFC) can result in improvements to cognition and emotion as well as brain oxygenation. This method is called transcranial photobiomodulation (tPBM). The investigators hypothesize that tPBM can improve cognition and brain oxygenation in adults with attention deficit hyperactivity disorder (ADHD). The investigators will investigate the effects of repeated tPBM sessions on cognitive functioning in adults with ADHD. Specifically, the investigators hypothesize that participants that receive tPBM will show improvements in response control, sustained attention, and working memory, as well as improvements in prefrontal hemodynamics and a reduction in ADHD symptoms.

Waitlist Available
Online Trial

The University of Texas at Austin

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 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 University

John Mitchell, PhD

Image of Kennedy Krieger Institute in Baltimore, United States.

Iron Supplementation for ADHD and Restless Sleep

8 - 18
All Sexes
Baltimore, MD

The goal of this clinical trial is to learn if iron supplementation works to restless sleep in youth with ADHD. A second goal is to learn if iron supplementation helps to ease ADHD symptoms. The main questions that this trial aims to answer are: Does 3 months of iron supplementation treatment improve parent- and youth self-reported sleep difficulties more than placebo? Does 3 months of iron supplementation treatment improve sleep as measured by actigraphy more than placebo? Does 3 months of iron supplementation treatment improve parent-reported and/or objectively measured attention more than placebo? Researchers will compare over-the-counter iron supplementation treatment to a placebo (a look-alike substance that contains no drug) to see if iron supplementation works to treat sleep difficulties in youth with ADHD. Participants will: * Take iron supplements every day for 3 months * Visit the clinic once before treatment begins and once at the end of treatment to complete tests and rating scales related to sleep and attention * Wear motion-monitoring leg bands while sleeping for one 2-week period before treatment begins and one 2-week period at the end of treatment

Phase 1 & 2
Waitlist Available

Kennedy Krieger Institute

Alison E Pritchard, PhD

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

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