Adzenys Xr-Odt

Narcolepsy, Depression, Attention Deficit Hyperactivity Disorder + 1 more

Treatment

2 FDA approvals

20 Active Studies for Adzenys Xr-Odt

What is Adzenys Xr-Odt

Amphetamine/Dextroamphetamine

The Generic name of this drug

Treatment Summary

Amphetamine is a controlled drug used for specific medical conditions. It was discovered in 1910 and first synthesized by 1927. In 1935, it was approved by Smith, Kline and French for treatment of drug-induced anesthesia, arousal, and insomnia. During World War II, amphetamine was used to keep soldiers alert, which led to an overproduction of the drug and an increase in black market sale. In 1976, it was approved by the FDA.

Adderall

is the brand name

image of different drug pills on a surface

Adzenys Xr-Odt Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Adderall

Amphetamine/Dextroamphetamine

1996

507

Approved as Treatment by the FDA

Amphetamine/Dextroamphetamine, also known as Adderall, is approved by the FDA for 2 uses such as Narcolepsy and Attention Deficit Hyperactivity Disorder .

Narcolepsy

Attention Deficit Hyperactivity Disorder

Used to treat Attention Deficit Hyperactivity Disorder (ADHD) in combination with Dextroamphetamine

Effectiveness

How Adzenys Xr-Odt Affects Patients

Amphetamine increases the levels of two key brain chemicals - noradrenaline in the prefrontal cortex and dopamine in the striatum - in a dose and time-dependent manner. This has been linked to improved school performance, behavior, and demeanor in ADHD patients. While amphetamine has been linked to cognitive enhancement, it can also lead to psychiatric dangers such as paranoia when misused. It can also worsen depression and anxiety.

How Adzenys Xr-Odt works in the body

Amphetamine has a similar structure to the catecholamine neurotransmitters, which makes it easy for it to be taken up by the presynaptic nerve terminals. Once inside the terminal, it is stored by a protein called VMAT2 and is then released into the synapse. Amphetamine also increases monoamine concentration by preventing its reuptake and inhibiting an enzyme called MAO that breaks down neurotransmitters. The l-isomer of amphetamine is less potent than the d-isomer when it comes to releasing dopamine.

When to interrupt dosage

The measure of Adzenys Xr-Odt is contingent upon the diagnosed illness, including Disease, Chronic Pain and Attention Deficit Hyperactivity Disorder. The amount additionally diverges as per the method of delivery (e.g. Oral or Tablet - Oral) noted in the table hereunder.

Condition

Dosage

Administration

Attention Deficit Hyperactivity Disorder

, 5.0 mg, 10.0 mg, 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, 18.8 mg, 2.5 mg/mL, 3.125 mg, 9.375 mg, 6.25 mg, 1.875 mg, 2.5 mg, 7.5 mg, 1.25 mg, 3.75 mg, 15.0 mg, 1.25 mg/mL, 18.75 mg, 25.0 mg, 7.26 mg, 12.11 mg, 2.42 mg, 9.69 mg, 14.53 mg, 4.84 mg, 20.0 mg, 60.0 mg, 40.0 mg, 30.0 mg

, Oral, Tablet - Oral, Tablet, Capsule, extended release, Capsule, extended release - Oral, Tablet, orally disintegrating - Oral, Tablet, orally disintegrating, Suspension, extended release - Oral, Suspension, extended release, Capsule, Capsule - Oral, Tablet, extended release, Tablet, extended release - Oral

Chronic Pain

, 5.0 mg, 10.0 mg, 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, 18.8 mg, 2.5 mg/mL, 3.125 mg, 9.375 mg, 6.25 mg, 1.875 mg, 2.5 mg, 7.5 mg, 1.25 mg, 3.75 mg, 15.0 mg, 1.25 mg/mL, 18.75 mg, 25.0 mg, 7.26 mg, 12.11 mg, 2.42 mg, 9.69 mg, 14.53 mg, 4.84 mg, 20.0 mg, 60.0 mg, 40.0 mg, 30.0 mg

, Oral, Tablet - Oral, Tablet, Capsule, extended release, Capsule, extended release - Oral, Tablet, orally disintegrating - Oral, Tablet, orally disintegrating, Suspension, extended release - Oral, Suspension, extended release, Capsule, Capsule - Oral, Tablet, extended release, Tablet, extended release - Oral

Narcolepsy

, 5.0 mg, 10.0 mg, 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, 18.8 mg, 2.5 mg/mL, 3.125 mg, 9.375 mg, 6.25 mg, 1.875 mg, 2.5 mg, 7.5 mg, 1.25 mg, 3.75 mg, 15.0 mg, 1.25 mg/mL, 18.75 mg, 25.0 mg, 7.26 mg, 12.11 mg, 2.42 mg, 9.69 mg, 14.53 mg, 4.84 mg, 20.0 mg, 60.0 mg, 40.0 mg, 30.0 mg

, Oral, Tablet - Oral, Tablet, Capsule, extended release, Capsule, extended release - Oral, Tablet, orally disintegrating - Oral, Tablet, orally disintegrating, Suspension, extended release - Oral, Suspension, extended release, Capsule, Capsule - Oral, Tablet, extended release, Tablet, extended release - Oral

Depression

, 5.0 mg, 10.0 mg, 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, 18.8 mg, 2.5 mg/mL, 3.125 mg, 9.375 mg, 6.25 mg, 1.875 mg, 2.5 mg, 7.5 mg, 1.25 mg, 3.75 mg, 15.0 mg, 1.25 mg/mL, 18.75 mg, 25.0 mg, 7.26 mg, 12.11 mg, 2.42 mg, 9.69 mg, 14.53 mg, 4.84 mg, 20.0 mg, 60.0 mg, 40.0 mg, 30.0 mg

, Oral, Tablet - Oral, Tablet, Capsule, extended release, Capsule, extended release - Oral, Tablet, orally disintegrating - Oral, Tablet, orally disintegrating, Suspension, extended release - Oral, Suspension, extended release, Capsule, Capsule - Oral, Tablet, extended release, Tablet, extended release - Oral

Warnings

Adzenys Xr-Odt Contraindications

Condition

Risk Level

Notes

Agitation

Do Not Combine

advanced arteriosclerosis

Do Not Combine

Drug abuse

Do Not Combine

Hyperthyroidism

Do Not Combine

Hypertensive disease

Do Not Combine

symptomatic cardiovascular disease

Do Not Combine

Pulse Frequency

Do Not Combine

Severe Hypersensitivity Reactions

Do Not Combine

Amphetamine/Dextroamphetamine may interact with Pulse Frequency

There are 20 known major drug interactions with Adzenys Xr-Odt.

Common Adzenys Xr-Odt Drug Interactions

Drug Name

Risk Level

Description

Clonidine

Major

The metabolism of Clonidine can be decreased when combined with Amphetamine.

Cyclophosphamide

Major

The metabolism of Cyclophosphamide can be decreased when combined with Amphetamine.

Dacomitinib

Major

The metabolism of Dacomitinib can be decreased when combined with Amphetamine.

Enasidenib

Major

The metabolism of Enasidenib can be decreased when combined with Amphetamine.

Erlotinib

Major

The metabolism of Erlotinib can be decreased when combined with Amphetamine.

Adzenys Xr-Odt Toxicity & Overdose Risk

The typical fatal dose of amphetamine is 6.4 mg/l. An overdose on amphetamine can lead to high body temperature, difficulty breathing, seizures, acidosis, kidney failure, liver damage, and coma. Neurological effects include confusion, aggression, irritability, headaches, and hallucinations. Cardiovascular effects include irregular heartbeats, heart muscle damage, heart attack, and stroke. Gastrointestinal effects include abdominal pain, vomiting, diarrhea, cramps, loss of appetite, and bleeding. Animal studies have not found amphetamine to cause cancer, chromosomal damage, or fertility issues.

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Adzenys Xr-Odt Novel Uses: Which Conditions Have a Clinical Trial Featuring Adzenys Xr-Odt?

Presently, there are 710 active studies investigating the possibility of Adzenys Xr-Odt to serve as a therapeutic intervention for Depression, Disease and Narcolepsy.

Condition

Clinical Trials

Trial Phases

Narcolepsy

2 Actively Recruiting

Not Applicable, Phase 1

Attention Deficit Hyperactivity Disorder

63 Actively Recruiting

Not Applicable, Phase 3, Phase 4, Phase 1, Phase 2

Chronic Pain

0 Actively Recruiting

Depression

305 Actively Recruiting

Not Applicable, Phase 1, Phase 2, Early Phase 1, Phase 4, Phase 3

Adzenys Xr-Odt Reviews: What are patients saying about Adzenys Xr-Odt?

5

Patient Review

5/3/2018

Adzenys Xr-Odt for Attention Deficit Disorder with Hyperactivity

I was amazed at how well this worked for my daughter! It was a real life-changer, but unfortunately we can't keep up with the costs.

5

Patient Review

3/19/2019

Adzenys Xr-Odt for Attention Deficit Disorder with Hyperactivity

I've never felt better taking a medication! Adzenys is so natural feeling-- no initial bump and no let down in the evenings. The only side effect I experienced was dry mouth. No problems with blood pressure or sleep, even though my blood pressure is controlled by medication. This drug helped me to be more focused, alert, and productive.

5

Patient Review

9/22/2016

Adzenys Xr-Odt for Attention Deficit Disorder with Hyperactivity

5

Patient Review

11/10/2016

Adzenys Xr-Odt for Attention Deficit Disorder with Hyperactivity

We switched my son to this treatment from Concerta and so far it's going well! We've found that it only lasts for about 8 hours, but there isn't the crash at the end of the day and he's been sleeping soundly through the night.

4.7

Patient Review

5/4/2021

Adzenys Xr-Odt for Attention Deficit Disorder with Hyperactivity

We made the switch to this treatment from Eveekeo when we were seeking an extended release medication for my son that he wouldn't have to take during school hours. We couldn't be happier. It lasts around seven to eight hours with no hard crash and no issues falling asleep at night. Very satisfied.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about adzenys xr-odt

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

How long does Adzenys XR-ODT last?

"Adzenys XR-ODT is a tablet that is designed to dissolve in your mouth instead of being swallowed. It has an effect that lasts for 10 to 12 hours."

Answered by AI

Is Adzenys XR-ODT the same as Adderall?

"Adzenys XR-ODT is the first FDA-approved extended-release orally disintegrating amphetamine tablet. It is bioequivalent to Adderall XR, but is not a generic of it."

Answered by AI

What is Adzenys XR-ODT used for?

"This medication is used to treat attention deficit hyperactivity disorder - ADHD. It works by altering the levels of certain natural substances in the brain. Amphetamine is a type of drug classified as a stimulant."

Answered by AI

How long does Adzenys XR-ODT take to kick in?

"The main difference between Adzenys XR-ODT and other medications is that Adzenys XR-ODT starts working within an hour, while other medications work instantly. Adzenys XR-ODT also lasts up to 12 hours, while other medications only last for a few hours."

Answered by AI

Clinical Trials for Adzenys Xr-Odt

Image of Stanford University School of Medicine in Stanford, United States.

BEAR Program for Suicidal Thoughts

18 - 75
Female
Stanford, CA

The current study aims to test the feasibility of a new form of group therapy for women who have a history of interpersonal trauma and current suicidal ideation. The Building Empowerment and Resilience (BEAR) Therapeutic group has been adapted for women who have experienced trauma and have current suicidal ideation. It incorporates psychological skills, psychoeducation about trauma and gender-based violence, and physical self-defense training, all within a therapeutic process. It will be implemented with women who have experienced interpersonal trauma (physical, sexual, or emotional abuse/neglect) and experience various mental health difficulties, including suicidal ideation. We aim to assess the feasibility to recruit and implement the BEAR group. Our ultimate aim is to assess whether the program can effect self-efficacy and suicidal ideation.

Waitlist Available
Has No Placebo

Stanford University School of Medicine

Jennifer Keller, PhD

Image of Western Psychiatric Hospital/University of Pittsburgh in Pittsburgh, United States.

Sleep and Circadian Interventions for Suicide

18 - 25
All Sexes
Pittsburgh, PA

The purpose of this study is to examine the extent to which delivering sleep and circadian focused interventions in addition to evidenced based psychiatric care for depression and suicide risk may contribute to decreasing suicide risk among high risk young adults. Investigators will evaluate three interventions targeting sleep in acutely suicidal college students enrolled in intensive outpatient treatment. Participants will be randomly assigned to one of three intervention groups: 1. Triple Chronotherapy (TCT)+ Transdiagnostic Sleep and Circadian Intervention (TSC) 2. Transdiagnostic Sleep and Circadian Intervention (TSC) 3. Sleep Feedback (SF) Participants will be followed for 6 months with primary outcome domains of suicidal thoughts and behaviors and depression evaluated by blinded clinicians at short (Days 1-4 of intervention), medium (2 months) and long (6 month) term intervals.

Waitlist Available
Has No Placebo

Western Psychiatric Hospital/University of Pittsburgh

Tina Goldstein, PhD

Image of University of South Florida in Tampa, United States.

WeACT Program for Caregivers of People With Dementia

18+
All Sexes
Tampa, FL

The goal of this clinical trial is to learn whether WeACT, a self-paced, web-based program, is feasible and helpful for adult family caregivers of a relative living with dementia. WeACT is based on acceptance and commitment therapy (ACT), which teaches skills to handle difficult thoughts and feelings and take steps toward what matters most. The main questions this study aims to answer are: * Can caregivers complete WeACT as planned? * Do caregivers show improvements in mental health and coping after using WeACT? * What are caregivers' experiences with the program, and what suggestions do they have to improve it? Participants will: * Complete six self-paced weekly online modules and use the daily practice section during the program. * Complete online questionnaires before starting and after completing the program. * Take part in one online interview about their experience.

Waitlist Available
Has No Placebo

University of South Florida

Areum Han

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Psilocybin Therapy for Anxiety and Depression in Cancer

18 - 85
All Sexes
Seattle, WA

This phase II trial tests the safety, side effects and how well group retreat psilocybin therapy works for the treatment of anxiety and depression in patients with solid tumors that have spread from where they first started (primary site) to other places in the body (metastatic) or with hematologic cancers for which no treatment is currently available (incurable). For patients with metastatic, incurable cancer, unrelieved anxiety and existential distress can cause profound suffering. Psilocybin therapy can relieve anxiety and existential distress by disrupting patterns of thinking that contribute to anxiety and depression. Psilocybin is a substance being studied in the treatment of anxiety or depression in patients with cancer. In this study, a pharmaceutical grade of psilocybin will be used that has been approved by the FDA for research, provided by Filament Health. Psilocybin acts on the brain by resetting the brain's activity and increasing connections between brain regions, particularly those involved in mood regulation and self-perception. In this study psilocybin is combined with structured discussions and reflections that enable patients to have new insights about their situation. In a prior study, group retreat psilocybin therapy was proven to be safe and this study tests a refined dosing regimen for symptoms of anxiety and depression in patients with metastatic solid tumors or incurable hematologic malignancies.

Phase 2
Waitlist Available

Fred Hutch/University of Washington Cancer Consortium

Anthony Back, MD

Image of Wahwala Iyohlogya/Peaceful Means in Pine Ridge, United States.

Lakota Family Acceptance Program for Depression and Anxiety

Any Age
All Sexes
Pine Ridge, SD

The goal of this open pilot trial (OPT) is to develop a Lakota-adapted Family Acceptance Project (LFAP) for Indigenous 2SLGBTQ+ youth and their caregivers. The OPT is specifically focused on acceptability, feasibility, and safety of programming and research protocols. The investigators will also examine pre- to post- changes on outcomes for the sole purposes of making sure scores on measures are changing in the hypothesized direction (e.g., depression scores are going from moderate to minimal as opposed to no change or depression scores increasing). Once enrolled in the study, participants complete a baseline survey. Then participants will engage in LFAP which is an 8-session group intervention; sessions will be scheduled once a week for eight weeks (at 2 hours per session). Participants will complete survey instruments before and immediately after the program sessions, in addition to post-program surveys and an exit interview.

Recruiting
Has No Placebo

Wahwala Iyohlogya/Peaceful Means (+1 Sites)

Katie Edwards, PhD

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FRAME for Heart Failure

18+
All Sexes
Cornwall, Canada

Heart failure is a high-risk, chronic condition that impacts patients' mental health. Approximately 50% of heart failure patients experience comorbid mental health conditions, such as stress, depression and anxiety, which affect their day-to-day lives. Despite this interconnection, the integration of mental health awareness and support into cardiac care remains limited. To address this gap, the FRAME (Foundation, Recognition, Awareness, Management, Engagement) intervention was co-designed by researchers, healthcare providers, health system decisionmakers, and patient partners. This pilot study evaluates the feasibility of implementing the FRAME intervention in pilot clinical sites within two health regions in Ontario, Canada, including team-based family medicine clinics, cardiac rehabilitation/specialist clinics, and emergency departments. Utilizing a pretest-posttest hybrid 1 model intervention design, this study evaluates process indicators and patient-focused outcomes through surveys and semi-structured qualitative interviews. Findings from this study will inform a future large scale cohort study and scalable integration of the FRAME tool into existing cardiac care pathways to enhance mental health awareness and support among heart failure patients.

Recruiting
Has No Placebo

Seaway Valley Community Health Centre (Cardiac Rehab Program) (+8 Sites)

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Behavioral Interventions for Depression in Students

Any Age
All Sexes
Cottage Grove, OR

The goal of this clinical trial is to learn if two behavioral interventions work to reduce office disciplinary referrals, improve attendance, and reduce depression and anxiety in 7th grade students. This project combines two evidence-based programs-the Inclusive Skill-building Learning Approach (ISLA) for school-wide discipline reform and the Family Check-Up Online (FCU-O) for family-centered support-in an adaptive design to examine the unique and additive effects of these interventions on these child behavior outcomes. The main questions it will answer are: 1. What is the relative efficacy of ISLA vs. School-as-Usual? 2. What is the optimal sequencing of these interventions? 3. Which overall sequence of intervention strategies was most effective? Researchers will compare 6 combinations of these interventions to see which combination and sequencing provides the best student outcomes. School personnel participating in the project will be trained to implement the two interventions at their school. They will answer surveys in the fall, winter, and spring of their year of participation. Parent and Youth participants will complete surveys at baseline and then again 6 months and 12 months later.

Waitlist Available
Has No Placebo

Lincoln Middle School (+12 Sites)

Beth Stormshak, PhD

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Living Well Program for Anxiety in Breast Cancer

18+
Female
Los Angeles, CA

The goal of this study is to evaluate the efficacy and cost-effectiveness of the Living Well Program, a digital therapeutic application with telecoaching support, in breast cancer patients with moderate-to-severe anxiety. The main question the study aims to answer is: does digital cognitive-behavioral therapy-based interventions decrease the overall healthcare costs of patients with stage II to IV breast cancer? The study has one group of participants who will use the Living Well app and telecoaching support. This group will be compared to retroactively matched controls. Over 3 months, patients will complete 21 mental health modules and 5 telecoaching sessions. In the following 3 months, they will complete any outstanding telecoaching sessions and modules while still being monitored, even if they finished all modules and sessions in the first 3 months. The 6 months after that will be the follow-up phase. They will still have access to the Living Well app and may continue to use it, and they will complete the same assessment questionnaires as baseline to identify any changes in their overall mental health.

Waitlist Available
Has No Placebo

Cedars-Sinai Medical Center

Scott Irwin, MD

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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

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