50 Participants Needed

Dyanavel XR for ADHD and Fatigue

Recruiting in Rochester Hills (>99 mi)
JS
Overseen ByJaime Saal, MA
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Rochester Center for Behavioral Medicine
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to study the impact of Dyanavel on co-occuring fatigue in adults with Attention Deficit/Hyperactivity Disorder. The main question it aims to answer is whether Dyanavel XR leads to a statistically significant reduction in fatigue compared to placebo, as measured by the Fatigue Symptom Inventory.

Will I have to stop taking my current medications?

The trial requires that some medications, especially stimulant medications like methylphenidate or amphetamine-based drugs, be stopped before starting the study. The primary investigator will review your current medications to decide if they might interfere with the study drug.

What data supports the effectiveness of the drug Dyanavel XR for ADHD and fatigue?

Adderall XR, which contains similar amphetamine components as Dyanavel XR, has been shown to be effective in treating ADHD in both children and adults, with a significant impact on quality of life and proven safety and efficacy.12345

Is Dyanavel XR safe for humans?

Dyanavel XR, an extended-release amphetamine, is generally well tolerated in clinical trials for ADHD, with safety shown in both children and adults. However, its safety in people with heart conditions hasn't been fully evaluated, though a study showed it could be safely used in adults with high blood pressure.36789

How is the drug Dyanavel XR unique for treating ADHD and fatigue?

Dyanavel XR is unique because it is an extended-release oral suspension of amphetamine, designed for those who have difficulty swallowing pills, allowing for flexible dosing based on daily needs. This formulation can be titrated (adjusted) with a single prescription, offering convenience and potentially better adherence for patients.1371011

Research Team

JY

Joel Young, MD

Principal Investigator

Medical Director

Eligibility Criteria

Adults aged 18-65 with ADHD and significant fatigue living in or near Michigan, who can swallow tablets and follow the study plan. They must score high on specific ADHD and fatigue scales, have no major intellectual deficits, agree to use two birth control methods if applicable, and sign informed consent.

Inclusion Criteria

My fatigue significantly interferes with my daily life and is severe.
I am between 18 and 65 years old.
I can sign and understand the consent form for this study.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks
1 visit (in-person)

Treatment

Participants receive Dyanavel XR or placebo with flexible titration dosing for 10 weeks

10 weeks
Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person)

Treatment Details

Interventions

  • Dyanavel XR
Trial OverviewThe trial is testing whether Dyanavel XR reduces fatigue in adults with ADHD more effectively than a placebo. Participants will be randomly assigned to receive either Dyanavel XR or a placebo, and their levels of fatigue will be measured using the Fatigue Symptom Inventory.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: Dyanavel XR (Active Agent)Active Control1 Intervention
Dyanavel 5, 10, 15 or 20 mg once daily in the morning
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo 5, 10, 15 or 20 mg once daily in the morning

Dyanavel XR is already approved in United States for the following indications:

🇺🇸
Approved in United States as Dyanavel XR for:
  • Attention Deficit Hyperactivity Disorder (ADHD)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rochester Center for Behavioral Medicine

Lead Sponsor

Trials
4
Recruited
150+

Findings from Research

In a study involving 22 adults with ADHD, both modafinil and dextroamphetamine significantly improved ADHD symptoms compared to placebo, with modafinil showing promise as an alternative treatment.
Both medications were well tolerated, suggesting that modafinil could be a viable option for adults seeking treatment for ADHD without the side effects commonly associated with traditional stimulants.
Efficacy of modafinil compared to dextroamphetamine for the treatment of attention deficit hyperactivity disorder in adults.Taylor, FB., Russo, J.[2018]
In a 2-year open-label study involving participants aged 6-17 with ADHD, extended-release guanfacine (GXR) demonstrated long-term safety and efficacy, with most adverse events being mild to moderate.
Significant improvements in ADHD symptoms were observed as early as the first month and continued throughout the 24-month treatment period, supporting GXR as a viable monotherapy for ADHD.
Long-term safety and efficacy of guanfacine extended release in children and adolescents with attention-deficit/hyperactivity disorder.Sallee, FR., Lyne, A., Wigal, T., et al.[2013]
Adderall XR is a long-acting psychostimulant approved for treating ADHD in both children and adults, with a 12-hour duration of action and demonstrated superior efficacy compared to the nonstimulant atomoxetine.
The largest effectiveness trial for ADHD therapies confirmed that Adderall XR significantly improves quality of life in children and shows proven safety and efficacy in adults, with potential benefits for treating comorbid conditions like oppositional defiant disorder.
Adderall XR: long acting stimulant for single daily dosing.Sallee, FR., Smirnoff, AV.[2019]

References

Efficacy of modafinil compared to dextroamphetamine for the treatment of attention deficit hyperactivity disorder in adults. [2018]
Long-term safety and efficacy of guanfacine extended release in children and adolescents with attention-deficit/hyperactivity disorder. [2013]
Adderall XR: long acting stimulant for single daily dosing. [2019]
Focus on Guanfacine Extended-release: A Review of its Use in Child and Adolescent Psychiatry. [2021]
Use of modafinil for the treatment of attention deficit/hyperactivity disorder. [2018]
Stimulant therapy in the management of ADHD: mixed amphetamine salts (extended release). [2019]
Amphetamine extended-release oral suspension for attention-deficit/hyperactivity disorder. [2019]
Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study to Evaluate the Efficacy and Safety of Amphetamine Extended-Release Tablets in Adults With Attention-Deficit/Hyperactivity Disorder. [2022]
Treating attention-deficit/hyperactivity disorder in adults: focus on once-daily medications. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Effects of dextroamphetamine on depression and fatigue in men with HIV: a double-blind, placebo-controlled trial. [2019]
Guanfacine extended release in the treatment of attention deficit hyperactivity disorder in children and adolescents. [2017]