Dyanavel Xr

Narcolepsy, Depression, Attention Deficit Hyperactivity Disorder + 1 more

Treatment

2 FDA approvals

20 Active Studies for Dyanavel Xr

What is Dyanavel Xr

Amphetamine/Dextroamphetamine

The Generic name of this drug

Treatment Summary

Amphetamine is a highly-restricted controlled drug that was discovered over 100 years ago. It is made up of the chemical alpha-methylphenethylamine and is composed of two forms of isomers, dextro- and levo-isomers. It was originally used to reduce drug-induced anesthesia and produce arousal and insomnia, and it was approved by the FDA in 1976. During World War II, amphetamine was used to help soldiers stay awake, and after the war, much of the surplus ended up in the black market, leading to its abuse.

Adderall

is the brand name

image of different drug pills on a surface

Dyanavel Xr 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 Dyanavel Xr Affects Patients

Amphetamine affects the concentration of the neurotransmitters noradrenaline and dopamine in the brain in a dose and time-dependent way. It has been suggested to improve intelligence test scores and increase school performance, behavior, and demeanor for people with ADHD. However, it has also been linked to psychiatric dangers when misused, such as paranoia and depression.

How Dyanavel Xr works in the body

Amphetamine has a similar structure to neurotransmitters like catecholamines. It works by attaching itself to sodium and chloride ions, which allow it to be taken in by the nerve terminals. It then competes with other neurotransmitters to get stored in the terminals, which causes them to be released into the synapse. This process is more effective in the d-isomer form of amphetamine. Amphetamine also works by limiting how much of the neurotransmitters are taken up and degraded by blocking the reuptake and monoamine oxidase enzymes. Additionally, it acts as a weak inhibitor of the mitochondrial enzyme MAO.

When to interrupt dosage

The proposed dosage of Dyanavel Xr is contingent upon the ascertained condition, like Disease, Chronic Pain and Attention Deficit Hyperactivity Disorder. The quantity of dosage can be found in the table below, in correlation with the mode of administration (e.g. Oral or Tablet - Oral).

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

Dyanavel Xr 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 Dyanavel Xr.

Common Dyanavel Xr 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.

Dyanavel Xr Toxicity & Overdose Risk

The lethal dosage of amphetamine is 6.4mg/l. Overdosing can cause a range of symptoms, such as increased body temperature, shallow breathing, seizures, acidosis, kidney failure, liver damage, and loss of consciousness. There may also be neurological effects such as agitation, aggression, headache, and hallucinations. Cardiovascular issues such as abnormal heart rhythm, heart muscle problems, heart attack, and stroke may also occur. In the digestive system, overdose may cause abdominal pain, vomiting, diarrhea, cramping, lack of appetite, and bleeding. Animals studies have not found any evidence of cancer, chromosome damage, or infertility

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

Currently, there are 710 active trials evaluating the potential of Dyanavel Xr to combat 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

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

4.3

Patient Review

11/6/2016

Dyanavel Xr for Attention Deficit Disorder with Hyperactivity

My daughter has Dysautonomia, as well as ADHD. Dyanavel has been a godsend for her; not only does it help with her ADHD symptoms, but it also acts as a vasoconstrictor, which has made a huge positive impact on my daughter's quality of life by minimizing her headaches and improving her GI system. The only problem we have is that the medication sticks to the pharmacy bottle and runs out days too soon, which is concerning.

3

Patient Review

12/19/2017

Dyanavel Xr for Attention Deficit Disorder with Hyperactivity

At first, this medication was really effective. But now, I find that it makes me depressed. I'm not sure if it's the medication or if it's because taking it makes me feel like a failure.
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Patient Q&A Section about dyanavel xr

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

How long does DYANAVEL XR last?

"The effects of DYANAVEL XR generally last for 13 hours after taking the medication."

Answered by AI

Is there a generic for DYANAVEL XR?

"While Dyanavel XR is an expensive drug used to treat ADHD, it is less popular than comparable drugs. There are no generic alternatives to Dyanavel XR currently."

Answered by AI

Is Dyanavel the same as Adderall?

"The three drugs mentioned are all manufactured by Neos Therapeutics and are used to treat ADHD. All three drugs are bioequivalent to Adderall XR."

Answered by AI

What is DYANAVEL XR used for?

"Amphetamine is a medication used to treat ADHD by changing the amounts of certain natural substances in the brain. It belongs to a class of drugs known as stimulants."

Answered by AI

Clinical Trials for Dyanavel Xr

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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

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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

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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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